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      <content styleCode="bold">Approved by FDA under NADA # 140-441<br/>
         <content styleCode="italics">Elanco</content> Baytril<sup>®</sup>
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      <br/>
      <content styleCode="bold">(enrofloxacin)</content>
      <br/>
      <content styleCode="bold">Taste Tabs<sup>®</sup> 22.7 mg, 68 mg, 136 mg Antibacterial Tablets For Dogs And Cats</content>
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               <title>CAUTION:</title>
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                  <paragraph>Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals.</paragraph>
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               <title>DESCRIPTION:</title>
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                  <paragraph>Enrofloxacin is a synthetic chemotherapeutic agent from the class of the quinolone carboxylic acid derivatives. It has antibacterial activity against a broad spectrum of Gram negative and Gram positive bacteria (See <linkHtml href="#Table_I">Tables I</linkHtml> and <linkHtml href="#Table_II">II</linkHtml>). It is rapidly absorbed from the digestive tract, penetrating into all measured body tissues and fluids (See <linkHtml href="#Table_III">Table III</linkHtml>). Tablets are available in three sizes (22.7, 68.0 and 136.0 mg enrofloxacin).</paragraph>
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                     <title>CHEMICAL NOMENCLATURE AND STRUCTURAL FORMULA:</title>
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                        <paragraph>1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid.</paragraph>
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               <title>ACTIONS:</title>
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                        <paragraph>
                           <content styleCode="bold">Microbiology:</content> Quinolone carboxylic acid derivatives are classified as DNA gyrase inhibitors. The mechanism of action of these compounds is very complex and not yet fully understood. The site of action is bacterial gyrase, a synthesis promoting enzyme. The effect on <content styleCode="italics">Escherichia coli </content>is the inhibition of DNA synthesis through prevention of DNA supercoiling. Among other things, such compounds lead to the cessation of cell respiration and division. They may also interrupt bacterial membrane integrity.<sup>1</sup>
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                        <paragraph>Enrofloxacin is bactericidal, with activity against both Gram negative and Gram positive bacteria. The minimum inhibitory concentrations (MICs) were determined for a series of 39 isolates representing 9 genera of bacteria from natural infections in dogs and cats, selected principally because of resistance to one or more of the following antibiotics: ampicillin, cephalothin, colistin, chloramphenicol, erythromycin, gentamicin, kanamycin, penicillin, streptomycin, tetracycline, triple sulfa and sulfa/trimethoprim. The MIC values for enrofloxacin against these isolates are presented in <linkHtml href="#Table_I">Table I</linkHtml>. Most strains of these organisms were found to be susceptible to enrofloxacin <content styleCode="italics">in vitro</content> but the clinical significance has not been determined for some of the isolates. </paragraph>
                        <paragraph>The susceptibility of organisms to enrofloxacin should be determined using enrofloxacin 5 mcg disks. Specimens for susceptibility testing should be collected prior to the initiation of enrofloxacin therapy.</paragraph>
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                           <caption>TABLE I — MIC Values for Enrofloxacin Against Canine and Feline Pathogens (Diagnostic laboratory isolates, 1984)</caption>
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                                       <content styleCode="bold">Organisms</content>
                                    </paragraph>
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                                       <content styleCode="bold">Isolates</content>
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                                    <paragraph>
                                       <content styleCode="bold">MIC Range</content>
                                       <br/>
                                       <content styleCode="bold">(mcg/mL)</content>
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                                    <paragraph>
                                       <content styleCode="italics">Bacteroides </content>spp.</paragraph>
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                                    <paragraph>2</paragraph>
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                                 <td valign="top">
                                    <paragraph>2</paragraph>
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                                    <paragraph>
                                       <content styleCode="italics">Bordetella bronchiseptica</content>
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                                    <paragraph>3</paragraph>
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                                    <paragraph>0.125-0.5</paragraph>
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                                    <paragraph>
                                       <content styleCode="italics">Brucella canis</content>
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                                    <paragraph>2</paragraph>
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                                    <paragraph>0.125-0.25</paragraph>
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                                    <paragraph>
                                       <content styleCode="italics">Clostridium perfringens</content>
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                                    <paragraph>1</paragraph>
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                                    <paragraph>0.5</paragraph>
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                                       <content styleCode="italics">Escherichia coli</content>
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                                    <paragraph>5<footnote ID="_Refid-333d39b6-0852-4f06-b8b6-5a0924810">Includes feline isolates.</footnote>
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                                    <paragraph>≤0.016-0.031</paragraph>
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                                    <paragraph>
                                       <content styleCode="italics">Klebsiella </content>spp.</paragraph>
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                                    <paragraph>11<footnoteRef IDREF="_Refid-333d39b6-0852-4f06-b8b6-5a0924810"/>
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                                    <paragraph>0.031-0.5</paragraph>
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                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Proteus mirabilis</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>6</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.062-0.125</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Pseudomonas aeruginosa</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>4</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.5-8</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Staphylococcus </content>spp.</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>5</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.125</paragraph>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>The inhibitory activity on 120 isolates of seven canine urinary pathogens was also investigated and is listed in <linkHtml href="#Table_II">Table II</linkHtml>.</paragraph>
                        <table ID="Table_II" styleCode="Noautorules" width="100%">
                           <caption>TABLE II — MIC Values for Enrofloxacin Against Canine Urinary Pathogens (Diagnostic laboratory isolates, 1985)</caption>
                           <col width="36%"/>
                           <col width="24%"/>
                           <col width="40%"/>
                           <tbody>
                              <tr>
                                 <td valign="bottom">
                                    <paragraph>
                                       <content styleCode="bold">Organisms</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="bottom">
                                    <paragraph>
                                       <content styleCode="bold">Isolates</content>
                                    </paragraph>
                                 </td>
                                 <td valign="bottom">
                                    <paragraph>
                                       <content styleCode="bold">MIC Range</content>
                                       <br/>
                                       <content styleCode="bold">(mcg/mL)</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">E. coli</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>30</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.06-2.0</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">P. mirabilis</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>20</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.125-2.0</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">K. pneumoniae</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>20</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.06-0.5</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">P. aeruginosa</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>10</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>1.0-8.0</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Enterobacter </content>spp.</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>10</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.06-1.0</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Staph. </content>(coag. +)</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>20</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.125-0.5</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">Strep. </content>(alpha hemol.)</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>10</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>0.5-8.0</paragraph>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>
                           <content styleCode="bold">Distribution in the Body: </content>Enrofloxacin penetrates into all canine and feline tissues and body fluids. Concentrations of drug equal to or greater than the MIC for many pathogens (See <linkHtml href="#Table_I">Tables I</linkHtml>, <linkHtml href="#Table_II">II</linkHtml> and <linkHtml href="#Table_III">III</linkHtml>) are reached in most tissues by two hours after dosing at 2.5 mg/kg and are maintained for 8-12 hours after dosing. Particularly high levels of enrofloxacin are found in urine. A summary of the body fluid/tissue drug levels at 2 to 12 hours after dosing at 2.5 mg/kg is given in <linkHtml href="#Table_III">Table III</linkHtml>.</paragraph>
                        <table ID="Table_III" styleCode="Noautorules" width="100%">
                           <caption>TABLE III — Body Fluid/Tissue distribution of Enrofloxacin in Dogs and Cats</caption>
                           <col width="42%"/>
                           <col width="17%"/>
                           <col width="13%"/>
                           <col width="16%"/>
                           <col width="13%"/>
                           <tbody>
                              <tr>
                                 <td valign="top"/>
                                 <td colspan="4" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Single Oral Dose = 2.5 mg/kg (1.13 mg/lb)</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top"/>
                                 <td align="center" colspan="4" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Post-treatment</content>
                                       <br/>
                                       <content styleCode="bold">Enrofloxacin Levels</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top"/>
                                 <td align="center" colspan="2" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Canine (n = 2)</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" colspan="2" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Feline (n = 4)</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Body Fluids (mcg/mL)</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">2 Hr.</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">8 Hr.</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">2 Hr.</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="bold">12 Hr.</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Bile</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.13</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.97</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Cerebrospinal Fluid</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.37</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.10</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Urine</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>43.05</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>55.35</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>12.81</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>26.41</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Eye Fluids</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.53</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.66</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.45</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.65</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Whole Blood</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.01</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Plasma</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.67</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.33</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Serum</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.48</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.18</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Tissues (mcg/g) Hematopoietic System</content>
                                    </paragraph>
                                 </td>
                                 <td colspan="4" valign="top"/>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Liver</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>3.02</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.84</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.37</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Spleen</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.45</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.85</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.33</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.52</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Bone Marrow</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.10</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.22</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.68</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.64</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Lymph Node</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.32</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.91</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.49</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.21</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Urogenital System</content>
                                    </paragraph>
                                 </td>
                                 <td colspan="4" valign="top"/>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Kidney</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.87</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.99</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.43</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.37</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Bladder Wall</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.98</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.16</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.55</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Testes</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.10</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.01</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.28</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Prostate</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.20</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.88</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.55</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Ovaries</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.78</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.56</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Uterine Wall</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.59</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.29</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.81</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.05</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Gastrointestinal and Cardiopulmonary Systems</content>
                                    </paragraph>
                                 </td>
                                 <td colspan="4" valign="top"/>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Lung</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.34</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.82</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.91</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.33</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Heart</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.88</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.78</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.84</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.32</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Stomach</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>3.24</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.16</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>3.26</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.27</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Small Intestine</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.10</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.11</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>2.72</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.40</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Large Intestine</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>–</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.94</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.10</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Other</content>
                                    </paragraph>
                                 </td>
                                 <td colspan="4" valign="top"/>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Fat</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.52</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.40</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.24</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.11</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Skin</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.66</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.48</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.46</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.17</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Muscle</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.62</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.77</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.53</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.29</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Brain</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.25</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.24</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.22</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.12</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Mammary Gland</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.45</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.21</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.36</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.30</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>Feces</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1.65</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>9.97</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.37</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>4.18</paragraph>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20250124"/>
                  </section>
               </component>
               <component>
                  <section ID="i4i_pharmacokinetics_id_006b25bd-a9fb-4bb4-86f3-f0e2908c6a7b">
                     <id root="3f2568e8-e9bf-45e5-9a03-c84cdb0c7d5a"/>
                     <code code="43682-4" codeSystem="2.16.840.1.113883.6.1" displayName="PHARMACOKINETICS SECTION"/>
                     <title> </title>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Pharmacokinetics:</content> In dogs, the absorption and elimination characteristics of the oral formulation are linear (plasma concentrations increase proportionally with dose) when enrofloxacin is administered at up to 11.5 mg/kg, twice daily.<sup>2</sup> Approximately 80% of the orally administered dose enters the systemic circulation unchanged. The eliminating organs, based on the drug’s body clearance time, can readily remove the drug with no indication that the eliminating mechanisms are saturated. The primary route of excretion is via the urine. The absorption and elimination characteristics beyond this point are unknown. In cats, no oral absorption information is available at other than 2.5 mg/kg, administered orally as a single dose. Saturable absorption and/or elimination processes may occur at greater doses. When saturation of the absorption process occurs, the plasma concentration of the active moiety will be less than predicted, based on the concept of dose proportionality. </paragraph>
                        <paragraph>Following an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb), enrofloxacin reached 50% of its maximum serum concentration in 15 minutes and peak serum level was reached in one hour. The elimination half-life in dogs is approximately 2<sup>1</sup>/<sub>2</sub>-3 hours at that dose, while in cats it is greater than 4 hours. In a study comparing dogs and cats, the peak concentration and the time to peak concentration were not different. </paragraph>
                        <paragraph>A graph indicating the mean serum levels following a dose of 2.5 mg/kg (1.13 mg/lb) in dogs (oral and intramuscular) and cats (oral) is shown in <linkHtml href="#id763">Figure 1</linkHtml>.</paragraph>
                        <renderMultiMedia ID="id763" referencedObject="id_c6aa92cc-ee95-44f6-83d5-82578f16cbe5">
                           <caption>Figure 1- Serum Concentrations of Enrofloxacin Following a Single Oral or Intramuscular Dose at 2.5 mg/kg in Dogs and a Single Oral Dose at 2.5 mg/kg in Cats. </caption>
                        </renderMultiMedia>
                        <paragraph>
                           <content styleCode="bold">Breakpoint: </content>Based on pharmacokinetic studies of enrofloxacin in dogs and cats after a single oral administration of 2.5 mg enrofloxacin/kg BW (i.e. half of the lowest-end single daily dose range for dogs and half the single daily dose for cats) and the data listed in <linkHtml href="#Table_I">Tables I</linkHtml> and <linkHtml href="#Table_II">II</linkHtml>, the following breakpoints are recommended for canine and feline isolates.</paragraph>
                        <table styleCode="Noautorules" width="100%">
                           <col width="22%"/>
                           <col width="15%"/>
                           <col width="18%"/>
                           <tbody>
                              <tr>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="underline">Zone Diameter (mm)</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="underline">MIC (μg/mL)</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>
                                       <content styleCode="underline">Interpretation</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" valign="top">
                                    <paragraph>≥ 21</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>≤ 0.5</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>Susceptible    (S)</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" valign="top">
                                    <paragraph>18 - 20</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>Intermediate  (I)</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" valign="top">
                                    <paragraph>≤ 17</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>≥ 2</paragraph>
                                 </td>
                                 <td valign="top">
                                    <paragraph>Resistant        (R)</paragraph>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable plasma levels. A report of “Intermediate” is a technical buffer and isolates falling into this category should be retested. Alternatively, the organism may be successfully treated if the infection is in a body site where drug is physiologically concentrated. A report of “Resistant” indicates that the achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected.</paragraph>
                        <paragraph>Standardized procedures require the use of laboratory control organisms for both standardized disk diffusion assays and standardized dilution assays. The 5 μg enrofloxacin disk should give the following zone diameters and enrofloxacin powder should provide the following MIC values for reference strains.</paragraph>
                        <table styleCode="Noautorules" width="100%">
                           <col width="28%"/>
                           <col width="15%"/>
                           <col width="17%"/>
                           <tbody>
                              <tr>
                                 <td valign="bottom">
                                    <paragraph>
                                       <content styleCode="underline">QC strain</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="bottom">
                                    <paragraph>
                                       <content styleCode="underline">MIC (μg/mL)</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" valign="bottom">
                                    <paragraph>Zone<br/>
                                       <content styleCode="underline">Diameter (mm)</content>
                                    </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">E. coli</content> ATCC 25922</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.008 - 0.03</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>32 - 40</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">P. aeruginosa </content>ATCC 27853</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>1 - 4</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>15 - 19</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">S. aureus </content>ATCC 25923</paragraph>
                                 </td>
                                 <td valign="top"/>
                                 <td align="center" valign="top">
                                    <paragraph>27 - 31</paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td valign="top">
                                    <paragraph>
                                       <content styleCode="italics">S. aureus </content>ATCC 29213</paragraph>
                                 </td>
                                 <td align="center" valign="top">
                                    <paragraph>0.03 - 0.12</paragraph>
                                 </td>
                                 <td valign="top"/>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20250124"/>
                     <component>
                        <observationMedia ID="id_c6aa92cc-ee95-44f6-83d5-82578f16cbe5">
                           <text>Figure 1</text>
                           <value mediaType="image/jpeg" xsi:type="ED">
                              <reference value="bay05-0000-02.jpg"/>
                           </value>
                        </observationMedia>
                     </component>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="i4i_indications_id_c2a637da-c2fe-477a-a715-ecffd9f23b6b">
               <id root="38d52f67-3639-4ed8-b19f-6943992356bb"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS:</title>
               <text>
                  <paragraph>Baytril (brand of enrofloxacin) Taste Tabs Antibacterial Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Baytril Antibacterial Tablets are indicated for use in dogs and cats.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_section_id_368edb16-d451-4080-b9aa-319b3e52d76e">
               <id root="ac1c5e1b-b428-488d-a3d8-cc70a217ad84"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <title>EFFICACY CONFIRMATION:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of <content styleCode="italics">Escherichia coli</content>, <content styleCode="italics">Klebsiella pneumoniae</content>, <content styleCode="italics">Proteus mirabilis</content>, and <content styleCode="italics">Staphylococcus intermedius</content>; respiratory infections (pneumonia, tonsillitis, rhinitis) associated with susceptible strains of <content styleCode="italics">Escherichia coli </content>and <content styleCode="italics">Staphylococcus aureus</content>; and urinary cystitis associated with susceptible strains of <content styleCode="italics">Escherichia coli</content>, <content styleCode="italics">Proteus mirabilis</content>, and <content styleCode="italics">Staphylococcus aureus</content>.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Palatability</content>: Free choice palatability in dogs was confirmed in a study in which 350 individual dosings resulted in a voluntary ingestion rate of 73%.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cats: </content>Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of <content styleCode="italics">Pasteurella multocida</content>, <content styleCode="italics">Staphylococcus aureus</content>, and <content styleCode="italics">Staphylococcus epidermidis</content>.</paragraph>
               </text>
               <effectiveTime value="20250124"/>
            </section>
         </component>
         <component>
            <section ID="i4i_contraindications_id_bb6541f3-e191-4af4-8bd1-3ff9902c3f49">
               <id root="2fa7da2c-3fc3-4c0e-82f7-a7e2a9b9026f"/>
               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <title>CONTRAINDICATIONS:</title>
               <text>
                  <paragraph>Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_adverse_effects_id_2d389c75-5c3f-47cf-9ba2-61592f0eb41e">
               <id root="1742ef7c-df93-4f53-9287-ff9380bb7059"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <title>ADVERSE REACTIONS:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Two of the 270 (0.7%) dogs treated with Baytril (brand of enrofloxacin) Tablets at 5.0 mg/kg per day in the clinical field studies exhibited side effects, which were apparently drug-related. These two cases of vomition were self-limiting.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Post-Approval Experience: </content>The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system.</paragraph>
                  <paragraph>Gastrointestinal: anorexia, diarrhea, vomiting, elevated liver enzymes</paragraph>
                  <paragraph>Neurologic: ataxia, seizures</paragraph>
                  <paragraph>Behavioral: depression, lethargy, nervousness</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cats: </content>No drug-related side effects were reported in 124 cats treated with Baytril (brand of enrofloxacin) Tablets at 5.0 mg/kg per day for 10 days in clinical field studies.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Post-Approval Experience: </content>The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system.</paragraph>
                  <paragraph>Ocular: Mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. Mydriasis may be an indication of impending or existing retinal changes.</paragraph>
                  <paragraph>Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea</paragraph>
                  <paragraph>Neurologic: ataxia, seizures</paragraph>
                  <paragraph>Behavioral: depression, lethargy, vocalization, aggression</paragraph>
                  <paragraph>To report adverse reactions, call 888-545-5973.<br/>For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or <linkHtml href="https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems">https://www.fda.gov/reportanimalae</linkHtml>.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_section_id_ca462394-ba20-4e58-9075-ccb1fd7c4a85">
               <id root="61180c51-e1cf-4064-88bf-76debc5613bd"/>
               <code code="60563-4" codeSystem="2.16.840.1.113883.6.1" displayName="SUMMARY OF SAFETY AND EFFECTIVENESS"/>
               <title>ANIMAL SAFETY SUMMARY:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Adult dogs receiving enrofloxacin orally at a daily dosage rate of 52 mg/kg for 13 weeks had only isolated incidences of vomition and inappetence. Adult dogs receiving the tablet formulation for 30 consecutive days at a daily treatment of 25 mg/kg did not exhibit significant clinical signs nor were there effects upon the clinical chemistry, hematological or histological parameters. Daily doses of 125 mg/kg for up to 11 days induced vomition, inappetence, depression, difficult locomotion and death while adult dogs receiving 50 mg/kg/day for 14 days had clinical signs of vomition and inappetence.</paragraph>
                  <paragraph>Adult dogs dosed intramuscularly for three treatments at 12.5 mg/kg followed by 57 oral treatments at 12.5 mg/kg, all at 12 hour intervals, did not exhibit either significant clinical signs or effects upon the clinical chemistry, hematological or histological parameters.</paragraph>
                  <paragraph>Oral treatment of 15 to 28 week old growing puppies with daily dosage rates of 25 mg/kg has induced abnormal carriage of the carpal joint and weakness in the hindquarters. Significant improvement of clinical signs is observed following drug withdrawal. Microscopic studies have identified lesions of the articular cartilage following 30 day treatments at either 5, 15 or 25 mg/kg in this age group. Clinical signs of difficult ambulation or associated cartilage lesions have not been observed in 29 to 34 week old puppies following daily treatments of 25 mg/kg for 30 consecutive days nor in 2 week old puppies with the same treatment schedule.</paragraph>
                  <paragraph>Tests indicated no effect on circulating microfilariae or adult heartworms (<content styleCode="italics">Dirofilaria immitis</content>) when dogs were treated at a daily dosage rate of 15 mg/kg for 30 days. No effect on cholinesterase values was observed.</paragraph>
                  <paragraph>No adverse effects were observed on reproductive parameters when male dogs received 10 consecutive daily treatments of 15 mg/kg/day at 3 intervals (90, 45 and 14 days) prior to breeding or when female dogs received 10 consecutive daily treatments of 15 mg/kg/day at 4 intervals: between 30 and 0 days prior to breeding, early pregnancy (between 10th &amp; 30th days), late pregnancy (between 40th &amp; 60th days), and during lactation (the first 28 days).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cats: </content>Cats in age ranges of 3 to 4 months and 7 to 10 months received daily treatments of 25 mg/kg for 30 consecutive days with no adverse effects upon the clinical chemistry, hematological or histological parameters. In cats 7-10 months of age treated daily for 30 consecutive days, 2 of 4 receiving 5 mg/kg, 3 of 4 receiving 15 mg/kg, 2 of 4 receiving 25 mg/kg and 1 of 4 nontreated controls experienced occasional vomition. Five to 7 month old cats had no side effects with daily treatments of 15 mg/kg for 30 days, but 2 of 4 animals had articular cartilage lesions when administered 25 mg/kg per day for 30 days.</paragraph>
                  <paragraph>Doses of 125 mg/kg for 5 consecutive days to adult cats induced vomition, depression, incoordination and death while those receiving 50 mg/kg for 6 days had clinical signs of vomition, inappetence, incoordination and convulsions, but they returned to normal.</paragraph>
                  <paragraph>Enrofloxacin was administered to thirty-two (8 per group), six- to eight-month-old cats at doses of 0, 5, 20, and 50 mg/kg of body weight once a day for 21 consecutive days. There were no adverse effects observed in cats that received 5 mg/kg body weight of enrofloxacin. The administration of enrofloxacin at 20 mg/kg body weight or greater caused salivation, vomition, and depression. Additionally, dosing at 20 mg/kg body weight or greater resulted in mild to severe fundic lesions on ophthalmologic examination (change in color of the fundus, central or generalized retinal degeneration), abnormal electroretinograms (including blindness), and diffuse light microscopic changes in the retina.</paragraph>
               </text>
               <effectiveTime value="20250124"/>
            </section>
         </component>
         <component>
            <section ID="i4i_interactions_id_b0a04766-e024-442f-a278-19fd0d05ce06">
               <id root="0d47823c-8ad9-44e5-ab16-687404637f9b"/>
               <code code="34073-7" codeSystem="2.16.840.1.113883.6.1" displayName="DRUG INTERACTIONS SECTION"/>
               <title>DRUG INTERACTIONS:</title>
               <text>
                  <paragraph>Compounds that contain metal cations (e.g., aluminum, calcium, iron, magnesium) may reduce the absorption of some quinolone-class drugs from the intestinal tract. Concomitant therapy with other drugs that are metabolized in the liver may reduce the clearance rates of the quinolone and the other drug.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Enrofloxacin has been administered to dogs at a daily dosage rate of 10 mg/kg concurrently with a wide variety of other health products including anthelmintics (praziquantel, febantel, sodium disophenol), insecticides (fenthion, pyrethrins), heartworm preventatives (diethylcarbamazine) and other antibiotics (ampicillin, gentamicin sulfate, penicillin, dihydrostreptomycin). No incompatibilities with other drugs are known at this time.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Cats: </content>Enrofloxacin was administered at a daily dosage rate of 5 mg/kg concurrently with anthelmintics (praziquantel, febantel), an insecticide (propoxur) and another antibacterial (ampicillin). No incompatibilities with other drugs are known at this time.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_warnings_id_ab73c940-f2d6-4e5f-9549-66ef91b2261d">
               <id root="5f3ea85b-74d8-4a71-a64d-776063629af4"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNINGS:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children.</content>
                  </paragraph>
                  <paragraph>Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposure. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.</paragraph>
                  <paragraph>For customer service or to obtain product information, including Safety Data Sheet, call 888-545-5973.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_precautions_id_0cd0f93c-0780-4582-bc7c-654c389350f5">
               <id root="a1208091-0674-47fb-9aa1-58294c0d7701"/>
               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS:</title>
               <text>
                  <paragraph>Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.</paragraph>
                  <paragraph>Quinolone-class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.</paragraph>
                  <paragraph>The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats.</paragraph>
               </text>
               <effectiveTime value="20230828"/>
            </section>
         </component>
         <component>
            <section ID="i4i_dosage_admin_id_fece1f53-345c-48b8-af39-8e1ba51b9387">
               <id root="c4b541af-3ed9-4645-bcae-38ecb59cac2f"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE AND ADMINISTRATION:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dogs: </content>Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition.</paragraph>
                  <table width="100%">
                     <col width="19%"/>
                     <col width="19%"/>
                     <col width="22%"/>
                     <col width="16%"/>
                     <col width="25%"/>
                     <tfoot>
                        <tr>
                           <td align="left" colspan="5" valign="top">All tablet sizes are double scored for accurate dosing.</td>
                        </tr>
                     </tfoot>
                     <tbody>
                        <tr>
                           <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">Weight</content>
                                 <br/>
                                 <content styleCode="bold">of <br/>Dog</content>
                              </paragraph>
                           </td>
                           <td align="center" colspan="4" styleCode="Rrule Botrule Toprule " valign="middle">
                              <paragraph>
                                 <content styleCode="bold">Once Daily Dosing Chart</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Lrule Botrule " valign="top"/>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>5.0 mg/kg</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>10.0 mg/kg</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>15.0 mg/kg</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>20.0 mg/kg</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>9.1 kg<br/>(20 lb)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>2 x 22.7 mg<br/>tablets</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 x 22.7 mg plus<br/>1 x 68 mg tablets</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 x 136 mg<br/>tablet</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 x 136 mg plus<br/>2 x 22.7 mg tablets</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" styleCode="Rrule Botrule Lrule " valign="top">
                              <paragraph>27.2 kg<br/>(60 lb)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 x 136 mg<br/>tablet</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>2 x 136 mg<br/>tablets</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>3 x 136 mg<br/>tablets</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>4 x 136 mg<br/>tablets</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">Cats: </content>Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days.</paragraph>
                  <table width="100%">
                     <col width="33%"/>
                     <col width="67%"/>
                     <tfoot>
                        <tr>
                           <td align="left" colspan="2" valign="top">All tablet sizes are double scored for accurate dosing.</td>
                        </tr>
                     </tfoot>
                     <tbody>
                        <tr>
                           <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">Weight</content>
                                 <br/>
                                 <content styleCode="bold">of Cat</content>
                              </paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">Once Daily Dosing Chart</content>
                                 <br/>
                                 <content styleCode="bold">(5 mg/kg/day)</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>5 lb<br/>(2.27 kg)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1/2 x 22.7 mg tablet</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>10 lb<br/>(4.5 kg)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 x 22.7 mg tablet</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" styleCode="Rrule Botrule Lrule " valign="top">
                              <paragraph>15 lb<br/>(6.8 kg)</paragraph>
                           </td>
                           <td align="center" styleCode="Rrule Botrule " valign="top">
                              <paragraph>1 and 1/2 x 22.7 mg tablets or<br/>1/2 x 68 mg tablet</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Palatability: </content>Most dogs will consume Baytril Taste Tabs Tablets willingly when offered by hand. Alternatively the tablet(s) may be offered in food or hand-administered (pilled) as with other oral tablet medications. In cats, Baytril Taste Tabs Tablets should be pilled. After administration, watch the animal closely to be certain the entire dose has been consumed.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dogs &amp; Cats: </content>The duration of treatment should be selected based on clinical evidence. Generally, administration of Baytril Tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be reevaluated and a different course of therapy considered.</paragraph>
                  <paragraph>The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.</paragraph>
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               <title>STORAGE:</title>
               <text>
                  <paragraph>Dispense tablets in tight containers only. Baytril Taste Tablets should be stored at or below 77° F (25° C).</paragraph>
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               <title>HOW SUPPLIED:</title>
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                     <col width="50%"/>
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                        <tr>
                           <td align="center" valign="bottom">
                              <paragraph>
                                 <content styleCode="bold">Baytril Tablets</content>
                                 <br/>
                                 <content styleCode="bold">Tablet Size</content>
                              </paragraph>
                           </td>
                           <td align="center" valign="bottom">
                              <paragraph>
                                 <content styleCode="bold">Tablets/Bottle</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>22.7 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>100 Double Scored</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>22.7 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>500 Double Scored</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>68.0 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>50 Double Scored</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>68.0 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>250 Double Scored</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>136.0 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>50 Double Scored</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="middle">
                              <paragraph>136.0 mg</paragraph>
                           </td>
                           <td align="center" valign="middle">
                              <paragraph>200 Double Scored</paragraph>
                           </td>
                        </tr>
                     </tbody>
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               <title>REFERENCES:</title>
               <text>
                  <list listType="ordered">
                     <item>
                        <caption>1</caption>Doughherty, T.J., &amp; Saukkonen, J.J. (1985). Membrane permeability changes associated with DNA gyrase inhibitors in Escherichia Coli.  Antimicrob Agents Chemother, 28 (2), 200-206.</item>
                     <item>
                        <caption>2</caption>Walker, R.D., Stein, G.E., Hauptmam, J.G., McDonald, K.H. (1992). Pharmacokinetic evaluation of enrofloxacin administered orally to healthy dogs.  Am J Vet Res, 53 (12):2315-2319.</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A.</content>
                  </paragraph>
                  <paragraph>Made in Germany<br/>90206961_YL600211A<br/>90206963_YL600211C<br/>90206967_YL600213A<br/>90206965_YL600213C<br/>90206969_YL600209A<br/>90206971_YL600209C<br/>
                  </paragraph>
                  <paragraph>Baytril is sold by Elanco or its affiliates and is not a product of Bayer. The product name Baytril is owned by Bayer and used under license. <br/>Taste Tabs, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.</paragraph>
                  <paragraph>©2022 Elanco or its affiliates.</paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                     </content>
                  </paragraph>
                  <paragraph>Approved by FDA under NADA # 140-441<br/>Revised: January 2022</paragraph>
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                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                     </content>
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                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                        <br/>(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 22.7 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>22.7 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">100 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">22.7</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or on the order <br/>of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals. </paragraph>
                  <paragraph>Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A.<br/>Approved by FDA under NADA # 140-441, Made in Germany </paragraph>
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                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                        <sup>TM</sup>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                     </content>
                     <br/>
                     <content styleCode="bold">(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 22.7 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>22.7 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">500 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">22.7</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or <br/>on the order of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-<br/>producing animals. </paragraph>
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               <title>Principal Display Panel - 68 mg Bottle Label</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                     </content>
                     <br/>
                     <content styleCode="bold">(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 68 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>68 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">50 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">68</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or on the order<br/>of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals. </paragraph>
                  <paragraph>Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A.<br/>Approved by FDA under NADA # 140-441, Made in Germany </paragraph>
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                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                     </content>
                     <br/>
                     <content styleCode="bold">(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 68 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>68 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">250 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">68</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or on the<br/>order of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals. </paragraph>
                  <paragraph>Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A.<br/>Approved by FDA under NADA # 140-441, Made in Germany</paragraph>
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               <title>Principal Display Panel – 136 mg Bottle Label</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                        <sup>TM</sup>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                        <br/>(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 136 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>136 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">50 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">136</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or on the <br/>order of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals. </paragraph>
                  <paragraph>Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A<br/>Approved by FDA under NADA # 140-441, Made in Germany</paragraph>
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                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>
                        <sup>TM</sup>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Baytril<sup>®</sup>
                        <br/>(enrofloxacin)<br/>Taste Tabs<sup>®</sup> 136 mg<br/>Antibacterial Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For The Treatment Of Susceptible Bacterial <br/>Pathogens In Dogs And Cats</content>
                  </paragraph>
                  <paragraph>Each tablet contains: <br/>136 mg enrofloxacin. </paragraph>
                  <paragraph>
                     <content styleCode="bold">200 Taste Tabs Tablets</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">136</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (U.S.A.) law restricts this drug to use by or on the <br/>order of a licensed veterinarian. </paragraph>
                  <paragraph>Federal law prohibits the extralabel use of this drug in food-producing animals. </paragraph>
                  <paragraph>Manufactured for: Elanco US Inc.<br/>Greenfield, IN 46140 U.S.A<br/>Approved by FDA under NADA # 140-441, Made in Germany</paragraph>
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