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            <name>Huvepharma, Inc.</name>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="23243-2220" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Tylovet<suffix>Soluble</suffix>
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                              <name>Tylosin tartrate</name>
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                              <denominator value="3970" unit="mL"/>
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                              <code code="5P4625C51T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TYLOSIN TARTRATE</name>
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                                    <code code="YEF4JXN031" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>TYLOSIN</name>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Tylovet® Soluble</content>
                     <br/>
                     <content styleCode="bold">(Tylosin Tartrate)</content>
                  </paragraph>
                  <paragraph>Equivalent to <content styleCode="bold">100 g (3.53 oz)</content> tylosin base</paragraph>
               </text>
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               <text>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (USA) law restricts this drug to use<br/>by or on the order of a licensed veterinarian.<br/>For oral use in chickens, turkeys, swine, and honey bees.</paragraph>
                  <paragraph>Macrolide Antibiotic<br/>Approved by FDA under ANADA # 200-473           </paragraph>
                  <paragraph>                                                                            Product 2220</paragraph>
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                  <paragraph>
                     <content styleCode="bold">                                                  Indications</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Chickens:</content> For the control of mortality caused by necrotic enteritis <content styleCode="bold">(NE)</content> associated with<br/>
                     <content styleCode="italics">Clostridium perfringens</content> in broiler chickens. As an aid in the treatment of chronic respiratory<br/>disease <content styleCode="bold">(CRD)</content> associated with <content styleCode="italics">Mycoplasma gallisepticum</content> in broiler and replacement chickens.<br/>For the control of CRD associated with <content styleCode="italics">Mycoplasma gallisepticum</content> at the time of vaccination or<br/>other stress in chickens. For the control of CRD associated with <content styleCode="italics">Mycoplasma synoviae</content> in broiler<br/>chickens.<br/>
                     <content styleCode="bold">Turkeys:</content> For the reduction in severity of effects of infectious sinusitis associated with<br/>
                     <content styleCode="italics">Mycoplasma gallisepticum.</content>
                     <br/>
                     <content styleCode="bold">Swine:</content> For the treatment and control of swine dysentery <content styleCode="bold">(SD)</content> associated with <content styleCode="italics">Brachyspira</content>
                     <br/>
                     <content styleCode="italics">hyodysenteriae.</content> For the treatment and control of SD associated with <content styleCode="italics">Brachyspira </content>
                     <br/>
                     <content styleCode="italics">hyodysenteriae</content> when followed immediately by Tylovet Type A medicated article in feed. For <br/>the control of porcine proliferative enteropathies (<content styleCode="bold">PPE</content>, ileitis) associated with <content styleCode="italics">Lawsonia</content>
                     <br/>
                     <content styleCode="italics">intracellularis</content> when followed immediately by Tylovet Type A medicated article in feed.<br/>
                     <content styleCode="bold">Honey Bees:</content> For the control of American Foulbrood (<content styleCode="italics">Paenibacillus larvae</content>).</paragraph>
                  <paragraph>
                     <content styleCode="bold">                                                Ingredients</content>
                     <br/>Tylosin (as tylosin tartrate) ………………………………………… 100 g</paragraph>
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                  <paragraph>
                     <content styleCode="bold">                        Dosage and Administration</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Dosages:</content>
                     <br/>
                     <content styleCode="bold"> Chickens:</content>
                     <br/>
                     <content styleCode="bold">  NE indication:</content> 851 to 1,419 mg/gallon (225 to 375 ppm) in drinking water.<br/>
                     <content styleCode="bold">   CRD indications:</content> 2,000 mg/gallon (528 ppm) in drinking water.<br/>
                     <content styleCode="bold">  Turkeys:</content> 2,000 mg/gallon (528 ppm) in drinking water.<br/>
                     <content styleCode="bold">  Swine:</content> 250 mg/gallon (66 ppm) in drinking water.<br/>
                     <content styleCode="bold">  Honey Bees:</content> 200 mg/colony in confectioners/powdered sugar.<br/>
                     <content styleCode="bold">Mixing Directions for Medicated Drinking Water:</content>
                     <br/>Always add the water to the powder. Do not pour the powder into the water. Prepare a fresh<br/>Tylovet Soluble solution every three days. When mixing and handling tylosin, use protective<br/>clothing and impervious gloves. If using a water medicating pump see table below, otherwise<br/>mix as follows:<br/>To assure thorough dissolution, first place the contents of one pouch in a mixing container and<br/>add one gallon of water (3785 mL) to the powder to make a concentrated solution. To make<br/>medicated drinking water containing 250 mg/gallon (66 ppm), mix this concentrated solution<br/>with water to make 400 gallons (1514 liters) of medicated drinking water. To make medicated<br/>drinking water containing 851 to 1,419 mg/gallon (225 to 375 ppm), mix this concentrated<br/>solution with water to make from 117 gallons + 51 ounces (444 liters) to 70 gallons + 64 ounces<br/>(267 liters) of medicated drinking water, respectively. To make medicated drinking water<br/>containing 2,000 mg/gallon (528 ppm), mix this concentrated solution with water to make 50<br/>gallons (189 liters) of medicated drinking water.</paragraph>
                  <paragraph/>
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               <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Restricted Drug (California) - Use Only as Directed.</content>
                     <br/>
                     <content styleCode="bold">To report suspected adverse drug events, for technical</content>
                     <br/>
                     <content styleCode="bold">assistance or to obtain a copy of the Safety Data Sheet</content>
                     <br/>
                     <content styleCode="bold">(SDS), contact Huvepharma, Inc. at 1-877-994-4883 or</content>
                     <br/>
                     <content styleCode="bold">www.huvepharma.us. For additional information about</content>
                     <br/>
                     <content styleCode="bold">adverse drug experience reporting for animal drugs, contact</content>
                     <br/>
                     <content styleCode="bold">FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content> Huvepharma Inc.<br/>Peachtree City, GA 30269, Made in Bulgaria<br/>Tylovet® is a registered trademark of Huvepharma EOOD       Rev. 06-2022<br/>Lot: 00000000000                      Exp. Date: 00.0000             Code: LB444v5-Tyl100-USA0622</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Mixing Directions for Water Medicating Pump (1:128 inclusion)*:</content>
                  </paragraph>
                  <table>
                     <caption/>
                     <tbody>
                        <tr>
                           <td valign="top">
                              <paragraph>Desired Concentration</paragraph>
                              <paragraph>in Drinking water</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>Pouches of</paragraph>
                              <paragraph>Tylovet Soluble</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>Volume of Water to Make</paragraph>
                              <paragraph>Stock Solution</paragraph>
                           </td>
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                        <tr>
                           <td valign="top">
                              <paragraph>      250 mg/gallon (66 ppm)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>1</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      3 gallons + 13 ounces</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>      851 mg/gallon (225 ppm)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>5</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      4 gallons + 77 ounces</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>   1,419 mg/gallon (375 ppm)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>9</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      5 gallons + 0 ounces</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>   2,000 mg/gallon (528 ppm)</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>10</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>      3 gallons + 115 ounces</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content>*This table applies only if the water medicating pump is set to deliver 1 ounce of stock solution</content>
                  </paragraph>
                  <paragraph>per gallon of drinking water.<br/>
                     <content styleCode="bold">Mixing Directions for use in Honey Bees:</content> Mix 200 mg tylosin in 20 g confectioners/powdered<br/>sugar. Use immediately.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">                                                   Directions for Use</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold"> Chickens:</content>
                     <content styleCode="bold">NE indication:</content> Administer medicated drinking water for a single five day period in broiler<br/>chickens. To assure all birds receive the intended medication, only medicated water should be<br/>available. These practices should be followed to assure both food safety and responsible<br/>antimicrobial drug use in chickens: 1) Use in flocks exhibiting signs of a necrotic enteritis outbreak,<br/>for example, increased mortality and lesions characteristic of necrotic enteritis upon necropsy; 2)<br/>Administer the full dose and dosing regimen once medication is initiated; 3) Use of Tylovet Soluble<br/>or another macrolide is not advised if additional therapy is needed beyond the original course of<br/>medication. <content styleCode="bold">CRD indications:</content> Administer medicated drinking water for three days; however,<br/>medicated water may be administered for one to five days depending upon severity of infection.<br/>Treated chickens must consume enough medicated water to provide 50 mg per pound of body<br/>weight per day. Only medicated water should be available to the birds.<br/>
                     <content styleCode="bold">Turkeys:</content> Administer medicated drinking water for three days; however, medicated water may be<br/>administered for two to five days depending upon severity of infection. Treated turkeys must<br/>consume enough medicated water to provide 60 mg per pound of body weight per day. Only<br/>medicated water should be available to the birds.<br/>
                     <content styleCode="bold">Swine: SD indication:</content> Administer medicated drinking water for 3 to 10 days, depending upon<br/>severity of infection. Alternatively, administer medicated drinking water for 3 to 10 days, followed<br/>by 40 to 100 g tylosin per ton of complete feed (Type C medicated feed manufactured from Tylovet<br/>Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while<br/>medicating with Tylovet Soluble. <content styleCode="bold">PPE indication:</content> Administer medicated drinking water for 3 to 10<br/>days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed<br/>manufactured from Tylovet A medicated article) for 2 to 6 weeks. Only medicated water should be<br/>available to swine while medicating with Tylovet Soluble.<br/>
                     <content styleCode="bold">Honey Bee Colonies:</content> Administer three treatments of medicated confectioners sugar once weekly<br/>for 3 weeks. The 200 mg dose is applied (dusted) over the top bars of the brood chamber.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">                                                      Warnings</content>
                     <br/>
                     <content styleCode="bold">User Safety Warnings:</content> Not for Human Use. Keep Out of Reach of Children. Avoid contact with<br/>human skin. Exposure to tylosin may cause a rash.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Residue Warnings:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Chickens</content> must not be slaughtered for food within 24 hours after treatment. Do not<br/>use in layers producing eggs for human consumption.<br/>
                     <content styleCode="bold">Turkeys</content> must not be slaughtered for food within five days after treatment.<br/>Do not use in layers producing eggs for human consumption.<br/>
                     <content styleCode="bold">Swine</content> must not be slaughtered for food within 48 hours after treatment.<br/>
                     <content styleCode="bold">Honey bees:</content> The drug should be fed early in the spring or fall and consumed by<br/>the bees before the main honey flow begins, to avoid contamination of<br/>production honey. Complete treatments at least 4 weeks prior to main honey flow.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">How supplied:</content>
                     <br/>Tylovet® Soluble is supplied in pouches of laminated aluminum foil, 100 g of tylosin activity<br/>per pouch; or HDPE jars with PP cap with heat sealable coating, 100 g of tylosin activity per jar.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Storage: Store at 20–25 ºC (68–77 ºF). Excursions permitted to 40ºC (104ºF). Avoid Moisture.</content>
                  </paragraph>
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