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   <title>Banamine<sub>®</sub>
      <br/> (flunixin meglumine paste)</title>
   <effectiveTime value="20250430"/>
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            <name>Merck Sharp &amp; Dohme Corp.</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="0061-0214" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Banamine</name>
                        <formCode code="C42967" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PASTE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Flunixin Meglumine</name>
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                        <ingredient classCode="ACTIM">
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                              <numerator value="1500" unit="mg"/>
                              <denominator value="30" unit="g"/>
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                           <ingredientSubstance>
                              <code code="8Y3JK0JW3U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FLUNIXIN MEGLUMINE</name>
                              <activeMoiety>
                                 <activeMoiety>
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                                    <name>FLUNIXIN</name>
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                           <quantity>
                              <numerator value="30" unit="g"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                              <low value="20111111"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Paste –1500 mg<br/>flunixin/syringe<br/>Veterinary</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">For Oral Use in Horses Only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">PRODUCT<br/>INFORMATION</content>
                  </paragraph>
               </text>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">DESCRIPTION</content> Each 30-g syringe of BANAMINE Paste contains flunixin meglumine equivalent to 1500 mg flunixin.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS BANAMINE</content> Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">ACTIVITY</content> Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">CONTRAINDICATIONS</content> There are no known contraindications to this drug when used as directed.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">WARNING</content> Do not use in horses intended for human consumption.</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS</content> The effect of BANAMINE Paste on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of BANAMINE Paste.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">SIDE EFFECTS</content> During field studies with BANAMINE Paste, no significant side effects were reported.</paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">DOSAGE AND ADMINISTRATION</content> The recommended dose of flunixin is 0.5 mg per lb of body weight once daily. The BANAMINE Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see <linkHtml href="#dt">dosage table</linkHtml>). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.</paragraph>
                  <table width="75%" ID="dt">
                     <caption>DOSAGE TABLE</caption>
                     <col width="25%" align="center" valign="top"/>
                     <col width="25%" align="center" valign="top"/>
                     <col width="25%" align="center" valign="top"/>
                     <col width="25%" align="center" valign="top"/>
                     <thead>
                        <tr>
                           <th valign="bottom">Syringe Mark<footnote>Use dial edge nearest syringe barrel to mark dose.</footnote>
                           </th>
                           <th valign="bottom">Horse Weight (lbs)</th>
                           <th valign="bottom">BANAMINE Paste Delivered (g)</th>
                           <th valign="bottom">Mg Flunixin Delivered</th>
                        </tr>
                     </thead>
                     <tbody>
                        <tr>
                           <td>0</td>
                           <td>—</td>
                           <td>—</td>
                           <td>—</td>
                        </tr>
                        <tr>
                           <td>250</td>
                           <td>250</td>
                           <td>2.5</td>
                           <td>125</td>
                        </tr>
                        <tr>
                           <td>500</td>
                           <td>500</td>
                           <td>5.0</td>
                           <td>250</td>
                        </tr>
                        <tr>
                           <td>750</td>
                           <td>750</td>
                           <td>7.5</td>
                           <td>375</td>
                        </tr>
                        <tr>
                           <td>1000</td>
                           <td>1000</td>
                           <td>10.0</td>
                           <td>500</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.</paragraph>
                  <paragraph>Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules or BANAMINE Paste on Days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">TOXICITY</content> No toxic effects were observed in rats given oral flunixin 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for fifteen consecutive days.</paragraph>
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               <text>
                  <paragraph>
                     <content styleCode="bold">HOW SUPPLIED</content> BANAMINE Paste, 1500 mg is available in a single 30-g syringe.</paragraph>
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                     <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Store below 25°C (77°F). Do not Freeze.</content>
                        </paragraph>
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               <text>
                  <paragraph>For patent information: <content styleCode="underline">http://www.merck.com/product/patent/home.html</content>
                  </paragraph>
               </text>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label</title>
               <text>
                  <paragraph>Syringe contains flunixin <br/>meglumine equivalent to <br/>1500 mg <br/>FLUNIXIN <br/>Net Wt 30 g</paragraph>
                  <paragraph>NDC 0061-0214-02</paragraph>
                  <paragraph>Banamine<sup>®</sup>
                     <br/>(flunixin meglumine paste) <br/>Paste</paragraph>
                  <paragraph>For oral use in horses only. <br/>Warning: Do not use in horses intended<br/> for human consumption. <br/>Caution: Federal law restricts this drug to <br/>use by or on the order <br/>of a licensed veterinarian. <br/>Approved by FDA under NADA # 137-409</paragraph>
                  <paragraph>MERCK <br/>Animal Health</paragraph>
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                     <text>PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label</text>
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