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   <title>panacur<sup>®</sup>
      <br/>(fenbendazole)</title>
   <effectiveTime value="20241104"/>
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            <name>Merck Sharp &amp; Dohme Corp.</name>
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                                    <name>FENBENDAZOLE</name>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>For Dogs And For Only The Carnivorous/Omnivorous Animals Listed</title>
               <effectiveTime value="20231116"/>
            </section>
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               <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>
               <effectiveTime value="20231116"/>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <title>DESCRIPTION</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> (fenbendazole) Granules 22.2% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.</paragraph>
                  <paragraph>The CAS Registry Number is 43210-67-9.</paragraph>
                  <paragraph>The chemical structure is:</paragraph>
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                  <paragraph>Panacur<sup>®</sup> Granules 22.2% contains 222 mg/g of fenbendazole.</paragraph>
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                     <text>Chemical Structure</text>
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               <title>ACTIONS</title>
               <text>
                  <paragraph>The antiparasitic action of Panacur<sup>®</sup> Granules 22.2% is believed to be due to the inhibition of energy metabolism in the parasite.</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>FOR THE FOLLOWING CARNIVOROUS/OMNIVOROUS ANIMALS</title>
               <text>
                  <paragraph>Lions <content styleCode="italics">(Panthera leo)</content>, Tigers <content styleCode="italics">(Panthera tigris)</content>, Cheetahs <content styleCode="italics">(Acinonyx jubatus)</content>, Pumas <content styleCode="italics">(Felis concolor)</content>, Jaguars <content styleCode="italics">(Panthera onca)</content>, Leopards <content styleCode="italics">(Panthera pardus)</content>, Panthers <content styleCode="italics">(Panthera</content> spp.<content styleCode="italics">)</content>, Grizzly Bears <content styleCode="italics">(Ursus horribilis)</content>, Polar Bears <content styleCode="italics">(Ursus maritimus)</content>, Black Bears <content styleCode="italics">(Ursus americanus)</content>
                  </paragraph>
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                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Do not use 14 days before or during the hunting season.</paragraph>
               </text>
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            <section ID="Indication">
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               <title>INDICATIONS</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> Granules 22.2% is used for control of the following internal parasites of the families <content styleCode="underline">Felidae</content> and <content styleCode="underline">Ursidae</content>.</paragraph>
                  <paragraph>
                     <content styleCode="underline">Felidae</content>: Lions <content styleCode="italics">(Panthera leo)</content>. For control of ascarids <content styleCode="italics">(Toxocara cati, Toxascaris leonina)</content>, hookworms <content styleCode="italics">(Ancylostoma</content> spp.<content styleCode="italics">)</content>.</paragraph>
                  <paragraph>Tigers <content styleCode="italics">(Panthera tigris)</content>. For control of ascarids <content styleCode="italics">(Toxocara cati, Toxascaris leonina)</content>, hookworms <content styleCode="italics">(Ancylostoma</content> spp.<content styleCode="italics">)</content>.</paragraph>
                  <paragraph>Cheetahs <content styleCode="italics">(Acinonyx jubatus)</content>. For control of ascarids <content styleCode="italics">(Toxocara cati, Toxascaris leonina)</content>.</paragraph>
                  <paragraph>Pumas <content styleCode="italics">(Felis concolor)</content>, Panthers <content styleCode="italics">(Panthera</content> spp.<content styleCode="italics">)</content>, Leopards <content styleCode="italics">(Panthera pardus)</content>, Jaguars <content styleCode="italics">(Panthera onca)</content>. For control of ascarids <content styleCode="italics">(Toxocara cati, Toxascaris leonina)</content>, hookworms <content styleCode="italics">(Ancylostoma</content> spp.<content styleCode="italics">)</content>, tapeworms <content styleCode="italics">(Taenia hydatigena, T. krabbei, T. taeniaeformis)</content>.</paragraph>
                  <paragraph>
                     <content styleCode="underline">Ursidae</content>: Black Bears <content styleCode="italics">(Ursus americanus)</content>. For control of ascarids (<content styleCode="italics">Baylisascaris transfuga, Toxascaris leonina)</content>, hookworms <content styleCode="italics">(Ancylostoma caninum)</content>, tapeworms <content styleCode="italics">(Taenia hydatigena, T. krabbei)</content>.</paragraph>
                  <paragraph>Polar Bears <content styleCode="italics">(Ursus maritimus)</content> and Grizzly Bears <content styleCode="italics">(Ursus horribilis)</content>. For control of ascarids <content styleCode="italics">(Baylisascaris transfuga, Toxascaris leonina)</content>.</paragraph>
               </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>DIRECTIONS</title>
               <text>
                  <paragraph>Efficacy is dependent on the correct dose level based on body weight over the appropriate treatment period. When possible, animals should be weighed to determine body weight accurately, otherwise weights can be estimated.</paragraph>
                  <paragraph>It is important that the appropriate dose of Panacur<sup>®</sup> be ingested. This may best be accomplished by applying the granules as a top dressing or mixing with a small portion of the food prior to offering the main meal.</paragraph>
                  <paragraph>Refer to the DOSAGE AND ADMINISTRATION portion of the labeling for determining the appropriate dose for each species of animal.</paragraph>
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               <title>DOSAGE AND ADMINISTRATION</title>
               <text>
                  <paragraph>The dose for <content styleCode="underline">Felidae</content> and <content styleCode="underline">Ursidae</content> is 10 mg/kg BW daily for 3 consecutive days. Please see <linkHtml href="#Indication">INDICATIONS</linkHtml> for details as to claims for animal and parasite.</paragraph>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">Directions:</content> The daily dose of 10 mg/kg (4.54 mg/lb) can be achieved as follows:</paragraph>
                        <paragraph>Using a gram scale, weigh out 1 gram of Panacur<sup>®</sup> Granules 22.2% for each 22 kg or 50 lbs body weight.</paragraph>
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               <title>TOXICOLOGY DATA</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> has been fed to pregnant and non-pregnant females and to male animals including <content styleCode="underline">Felidae</content> and <content styleCode="underline">Ursidae</content> at ten times the recommended dose for twice the recommended treatment period without effect on reproduction. In one puma and one jaguar, ten times the recommended dose given for twice the recommended duration showed evidence of inappetence when administered the Panacur<sup>®</sup> Granules.</paragraph>
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               <title>SIDE EFFECTS</title>
               <text>
                  <paragraph>In studies conducted in a variety of captive animals, loose stools have been reported in pumas, black bears, and ruminants. In one puma and one jaguar, periods of inappetence followed the initial consumption of fenbendazole at ten times the recommended treatment level.</paragraph>
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               <title>DRUG REACTIONS</title>
               <text>
                  <paragraph>There are currently no data available to support the use of Panacur<sup>®</sup> Granules 22.2% in conjunction with other nutritional and drug substances in <content styleCode="underline">Felidae</content> and <content styleCode="underline">Ursidae</content>. However, experience with the drug under actual conditions of use has not revealed any incompatibilities with Panacur<sup>®</sup>.</paragraph>
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               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS</title>
               <text>
                  <paragraph>Medicated food must be fully consumed for Panacur<sup>®</sup> to be effective.</paragraph>
               </text>
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               <title>FOR DOGS</title>
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               <title>DOSAGE</title>
               <text>
                  <paragraph>50 mg/kg (22.7 mg/lb) daily for 3 consecutive days for the removal of ascarids (<content styleCode="italics">Toxocara canis</content>, <content styleCode="italics">Toxascaris leonina</content>), hookworms (<content styleCode="italics">Ancylostoma caninum</content>, <content styleCode="italics">Uncinaria stenocephala</content>), whipworms (<content styleCode="italics">Trichuris vulpis</content>), and tapeworms (<content styleCode="italics">Taenia pisiformis</content>).</paragraph>
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               <title>DIRECTIONS</title>
               <text>
                  <paragraph>The daily dosage of 50 mg/kg (22.7 mg/lb) can be achieved as follows:</paragraph>
                  <paragraph>Using a gram scale, weigh out 1 gram of Panacur<sup>®</sup> (fenbendazole) Granules 22.2% for each 4.44 kg or 10 lbs body weight.</paragraph>
                  <paragraph>Daily dosages must be repeated for 3 consecutive days. Mix the appropriate amount of drug with a small amount of the usual food: dry dog food may require slight moistening to facilitate mixing with the drug.</paragraph>
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               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <title>CONTRAINDICATIONS</title>
               <text>
                  <paragraph>None known.</paragraph>
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               <title>TOXICOLOGY DATA</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> Granules 22.2% did not cause toxicity when administered to weaned pups at doses equal to 5 times the recommended daily dose and for 2 times the duration of treatment.</paragraph>
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               <title>ADVERSE REACTIONS</title>
               <text>
                  <paragraph>Another benzimidazole has been reported to cause hepatotoxicity clinically in canines. However, this effect has not been reported during the clinical use of fenbendazole. In US clinical studies, 3 of 240 dogs vomited which may have been drug related.</paragraph>
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               <title>DRUG REACTIONS</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> Granules 22.2% has been administered to dogs in clinical trials along with a wide variety of other drugs including antibiotics, steroids, anesthetics, tranquilizers, vitamins, and minerals. No incompatibilities with other drugs are known at this time.</paragraph>
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               <title>PRECAUTIONS</title>
               <text>
                  <paragraph>Medicated food must be fully consumed to be effective. Dispensing containers must be labeled with drug identification and directions for use.</paragraph>
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               <title>HOW SUPPLIED</title>
               <text>
                  <paragraph>Panacur<sup>®</sup> Granules 22.2% is supplied in 1 lb jars.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Keep this and all medication out of the reach of children.</content>
                  </paragraph>
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                        <paragraph>
                           <content styleCode="bold">Store at controlled room temperature 68-77°F (20-25°C).</content>
                        </paragraph>
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                  <paragraph>Manufactured by:<br/>Intervet GesmbH<br/>Vienna, Austria</paragraph>
                  <paragraph>Distributed by:<br/>Intervet Inc.<br/>(d/b/a Merck Animal Health)<br/>Madison, NJ 07940</paragraph>
                  <paragraph>Fenbendazole (active ingred.)<br/>Made in: see imprint. Formulated in Austria.</paragraph>
                  <paragraph>Approved by FDA under<br/>NADA # 121-473<br/> Rev. 07/22</paragraph>
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               <title>PRINCIPAL DISPLAY PANEL - 454 g Jar Carton</title>
               <text>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
                  <paragraph>panacur<sup>®</sup>
                     <br/>(fenbendazole)</paragraph>
                  <paragraph>Dewormer</paragraph>
                  <paragraph>Granules 22.2%<br/>(222 mg/g)</paragraph>
                  <paragraph>FOR DOGS AND FOR ONLY THE<br/>CARNIVOROUS/OMNIVOROUS ANIMALS<br/>LISTED ON THE SIDE PANEL</paragraph>
                  <paragraph>CAUTION: Federal law restricts this drug to use<br/>by or on the order of a licensed veterinarian.</paragraph>
                  <paragraph>1 lb (454 g)</paragraph>
                  <paragraph>Retain carton for complete<br/>product information.</paragraph>
                  <paragraph>MERCK<br/>Animal Health</paragraph>
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                     <text>PRINCIPAL DISPLAY PANEL - 454 g Jar Carton</text>
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