<text/> <effectiveTime value="20150226"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="13985-707" codeSystem="2.16.840.1.113883.6.69"/> <name>Prevail</name> <formCode code="C42967" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PASTE"/> <asEntityWithGeneric> <genericMedicine> <name>flunixin meglumine</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="1500" unit="mg"/> <denominator value="30" unit="g"/> </quantity> <ingredientSubstance> <code code="8Y3JK0JW3U" codeSystem="2.16.840.1.113883.4.9"/> <name>FLUNIXIN MEGLUMINE</name> <activeMoiety> <activeMoiety> <code code="356IB1O400" codeSystem="2.16.840.1.113883.4.9"/> <name>FLUNIXIN</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="30" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="13985-707-15" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43202" displayName="SYRINGE" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20150226"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANADA200581" root="2.16.840.1.113883.3.150"/> <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="Le18da724-9d23-438e-bc03-c9a6379caab0"> <id root="94420940-9d8e-4869-b31d-83c85540af37"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">Prevail<sup>®</sup> <br/>(flunixin meglumine paste)<br/>Equine Paste</content> </paragraph> <paragraph> <content styleCode="bold">Apple Flavored</content> </paragraph> <paragraph> <content styleCode="bold">CAUTION:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph> <paragraph> <content styleCode="bold">DESCRIPTION:</content> Each 30-g syringe of Flunazine Equine Paste contains flunixin meglumine equivalent to 1500 mg flunixin.</paragraph> </text> <effectiveTime value="20240401"/> </section> </component> <component> <section ID="L855656f4-2363-4fd1-8cdd-6ec7575b43e0"> <id root="0ee7462d-3ffa-439c-8c72-df217b903763"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content> <content styleCode="bold">INDICATIONS:</content> Prevail Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.</content> </paragraph> <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 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and<content> duration of activity is 24 to 36 hours.</content> </paragraph> </text> <effectiveTime value="20240123"/> </section> </component> <component> <section ID="Laf82ceaa-a100-40b7-acf2-b10ceca87f5d"> <id root="c129ec7e-57d5-405a-a5cc-4fdb15c8e0e8"/> <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">For oral use in horses only</content> </paragraph> <paragraph> <content styleCode="bold">CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed.<br/>WARNING: Do not use in horses intended for human consumption.</content> </paragraph> <paragraph> <content styleCode="bold">PRECAUTIONS:</content> The effect of flunixin meglumine 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 flunixin meglumine.<br/> <content styleCode="bold">SIDE EFFECTS:</content> During field studies with flunixin meglumine, no significant side effects were reported.</paragraph> <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VET or online at www.fda.gov/reportanimalaeduration of activity is 24 to 36 hours.</paragraph> </text> <effectiveTime value="20240123"/> </section> </component> <component> <section ID="Laadb9f64-b798-4cc3-b64a-0f6898fc6d4e"> <id root="72a01dad-4893-4151-817b-812b4ad98d0b"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & 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 Prevail Equine Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.</paragraph> <paragraph> <content styleCode="bold">DOSAGE TABLE</content> </paragraph> <table width="100%"> <caption/> <tbody> <tr> <td> Syringe Mark*</td> <td> Horse Weight (lbs)</td> <td> Prevail™ Equine Paste Delevered (g)</td> <td>mg flunixin Delivered </td> </tr> <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>* Use dial edge nearest syringe barrel to mark dose.</paragraph> <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 of Prevail™ Injectable Solution, followed by Prevail™ Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days.</paragraph> <paragraph> <br/> <content styleCode="bold">TOXICITY:</content> No toxic effects were observed in rats given oral flunixin meglumine 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 5 consecutive days.</paragraph> </text> <effectiveTime value="20240123"/> </section> </component> <component> <section ID="L219a4638-d90c-4e42-8335-eef6f6241675"> <id root="1510f646-80ad-43f7-bf6d-6b177789077a"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph> <content styleCode="bold">Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (between 59°F - 86°F)</content> </paragraph> <paragraph>See product information sheet for additional information.</paragraph> <paragraph>Approved by FDA under ANADA # 200-581</paragraph> </text> <effectiveTime value="20240123"/> </section> </component> <component> <section ID="L1e15ca33-b260-4fc2-888c-fa1e4acfd0d2"> <id root="75a70228-d463-42f1-9ec7-2df943c74df0"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="L6631dabe-63a6-43d1-a062-b54a3a759432"/> </paragraph> </text> <effectiveTime value="20240401"/> <component> <observationMedia ID="L6631dabe-63a6-43d1-a062-b54a3a759432"> <text>image description</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="label.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>


               
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                     <content styleCode="bold">Prevail<sup>®</sup>
                        <br/>(flunixin meglumine paste)<br/>Equine Paste</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Apple Flavored</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DESCRIPTION:</content> Each 30-g syringe of Flunazine Equine Paste contains flunixin meglumine equivalent to 1500 mg flunixin.</paragraph>
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                     <content>
                        <content styleCode="bold">INDICATIONS:</content> Prevail Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.</content>
                  </paragraph>
                  <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 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and<content> duration of activity is 24 to 36 hours.</content>
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                     <content styleCode="bold">For oral use in horses only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed.<br/>WARNING: Do not use in horses intended for human consumption.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> The effect of flunixin meglumine 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 flunixin meglumine.<br/>
                     <content styleCode="bold">SIDE EFFECTS:</content> During field studies with flunixin meglumine, no significant side effects were reported.</paragraph>
                  <paragraph>To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VET or online at www.fda.gov/reportanimalaeduration of activity is 24 to 36 hours.</paragraph>
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                  <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 Prevail Equine Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DOSAGE TABLE</content>
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                     <caption/>
                     <tbody>
                        <tr>
                           <td> Syringe Mark*</td>
                           <td> Horse Weight (lbs)</td>
                           <td> Prevail™ Equine Paste Delevered (g)</td>
                           <td>mg flunixin Delivered </td>
                        </tr>
                        <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>* Use dial edge nearest syringe barrel to mark dose.</paragraph>
                  <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 of Prevail™ Injectable Solution, followed by Prevail™ Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days.</paragraph>
                  <paragraph>
                     <br/>
                     <content styleCode="bold">TOXICITY:</content> No toxic effects were observed in rats given oral flunixin meglumine 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 5 consecutive days.</paragraph>
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                     <content styleCode="bold">Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (between 59°F - 86°F)</content>
                  </paragraph>
                  <paragraph>See product information sheet for additional information.</paragraph>
                  <paragraph>Approved by FDA under ANADA # 200-581</paragraph>
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