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   <title>Moxidectin ORAL SHEEP DRENCH<sub>™</sub> (moxidectin)</title>
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               <title>Moxidectin Oral Sheep Drench<br/>(moxidectin)<br/>Antiparasitic</title>
               <text>
                  <paragraph>Approved by FDA under ANADA # 200-852<br/>Contains 1 mg moxidectin/mL<br/>For Treatment and Control of Infections Due to Internal Parasites of Sheep.<br/>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.</paragraph>
                  <paragraph>
                     <content styleCode="bold">See booklet for additional information</content>. Restricted Drug (California) - Use Only as Directed</paragraph>
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               <title>PRODUCT DESCRIPTION:</title>
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                  <paragraph>Durvet Moxidectin Oral Sheep Drench is a ready-to-use solution containing 0.1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite.</paragraph>
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               <title>INDICATIONS:</title>
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                  <paragraph>Durvet Moxidectin Oral Sheep Drench, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L<sub>4</sub>) stages of the following internal parasites of sheep:</paragraph>
                  <paragraph>
                     <content styleCode="bold">Parasites</content>
                     <br/>
                     <content styleCode="italics">Haemonchus contortus</content> – Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Teladorsagia circumcincta </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Teladorsagia trifurcata</content> – Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Trichostrongylus axei</content> – Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Trichostrongylus colubriformis </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Trichostrongylus vitrinus </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Cooperia curticei </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Cooperia oncophora</content> – Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Oesophagostomum columbianum </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Oesophagostomum venulosum </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Nematodirus battus </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Nematodirus filicollis </content>– Adult and L<sub>4</sub>
                     <br/>
                     <content styleCode="italics">Nematodirus spathiger </content>– Adult and L<sub>4</sub>
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               <title>ADMINISTRATION:</title>
               <text>
                  <paragraph>Durvet Moxidectin Oral Sheep Drench is ready-to-use. Administer 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of the sheep, using any standard drenching equipment. Check dose rates and equipment before drenching. Do not overdose. Do not mix with any other products before administration. Avoid contaminating the drench solution.</paragraph>
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               <title>DOSAGE:</title>
               <text>
                  <paragraph>The recommended rate of administration for Durvet Moxidectin Oral Sheep Drench is 1 mL per 11 lb (5 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of drench in 1.0 mL increments and it must be administered based on the weight of animal being treated.</paragraph>
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                        <tr>
                           <td align="center" colspan="2">
                              <content styleCode="bold">  Body Weight</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Dose</content>
                           </td>
                           <td align="center" colspan="2">
                              <content styleCode="bold">  Body Weight</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Dose</content>
                           </td>
                           <td align="center" colspan="2">
                              <content styleCode="bold">  Body Weight</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Dose</content>
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                        <tr>
                           <td align="center"> 11 lb</td>
                           <td align="center"> 5 kg</td>
                           <td align="center"> 1 mL</td>
                           <td align="center"> 66 lb</td>
                           <td align="center"> 30 kg</td>
                           <td align="center"> 6 mL</td>
                           <td align="center"> 121 lb</td>
                           <td align="center"> 55 kg</td>
                           <td align="center"> 11 mL</td>
                        </tr>
                        <tr>
                           <td align="center"> 22 lb</td>
                           <td align="center"> 10 kg</td>
                           <td align="center"> 2 mL</td>
                           <td align="center"> 77 lb</td>
                           <td align="center"> 35 kg</td>
                           <td align="center"> 7 mL</td>
                           <td align="center"> 132 lb</td>
                           <td align="center"> 60 kg</td>
                           <td align="center"> 12 mL</td>
                        </tr>
                        <tr>
                           <td align="center"> 33 lb</td>
                           <td align="center"> 15 kg</td>
                           <td align="center"> 3 mL</td>
                           <td align="center"> 88 lb</td>
                           <td align="center"> 40 kg</td>
                           <td align="center"> 8 mL</td>
                           <td align="center"> 143 lb</td>
                           <td align="center"> 65 kg</td>
                           <td align="center"> 13 mL</td>
                        </tr>
                        <tr>
                           <td align="center"> 44 lb</td>
                           <td align="center"> 20 kg</td>
                           <td align="center"> 4 mL</td>
                           <td align="center"> 99 lb</td>
                           <td align="center"> 45 kg</td>
                           <td align="center"> 9 mL</td>
                           <td align="center"> 154 lb</td>
                           <td align="center"> 70 kg</td>
                           <td align="center"> 14 mL</td>
                        </tr>
                        <tr>
                           <td align="center"> 55 lb</td>
                           <td align="center"> 25 kg</td>
                           <td align="center"> 5 mL</td>
                           <td align="center"> 110 lb</td>
                           <td align="center"> 50 kg</td>
                           <td align="center"> 10 mL</td>
                           <td align="center"> 165 lb</td>
                           <td align="center"> 75 kg</td>
                           <td align="center"> 15 mL</td>
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                  <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
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               <title>HUMAN WARNINGS:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Not for use in humans. Keep this and all drugs out of the reach</content>
                     <content styleCode="bold"> of children.</content> To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com.  For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae</paragraph>
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               <title>RESIDUE WARNINGS:</title>
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                  <paragraph>Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.</paragraph>
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               <title>ENVIRONMENTAL WARNINGS:</title>
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                  <paragraph>Studies indicate that when moxidectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Free moxidectin may adversely affect fish and certain aquatic organisms. Do not contaminate water by direct application or by improper disposal of drug containers.</paragraph>
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               <title>ANIMAL SAFETY WARNINGS:</title>
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                  <paragraph>Durvet Moxidectin Oral Sheep Drench has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.</paragraph>
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               <title>OTHER WARNINGS</title>
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                  <list listType="unordered">
                     <item>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.</item>
                  </list>
                  <list listType="unordered">
                     <item>Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.</item>
                  </list>
                  <list listType="unordered">
                     <item>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).</item>
                  </list>
                  <list listType="unordered">
                     <item>A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</item>
                  </list>
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                     <item>Macrocyclic lactones provide prolonged drug exposure that may increase selection pressure for resistant parasites. This effect may be more pronounced in extended-release formulations.</item>
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               <title>ANIMAL SAFETY:</title>
               <text>
                  <paragraph>A well-controlled U.S. study has demonstrated an adequate margin of safety to allow treatment of sheep four months of age and older with moxidectin. In this study no signs of toxicity were seen in sheep given up to 5 times the recommended dose. Reproductive safety studies evaluating the use of Durvet Moxidectin Oral Sheep Drench in breeding ewes and rams have not been conducted in the U.S.</paragraph>
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               <title>STORAGE:</title>
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                  <paragraph>Store product at or below 77°F (25°C). Protect from light.</paragraph>
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               <title>DISPOSAL:</title>
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                  <paragraph>Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.</paragraph>
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                  <paragraph>Restricted Drug (California) - Use Only as Directed<br/>Approved by FDA under # ANADA 200-852</paragraph>
                  <paragraph>Made in U.S.A.<br/>Manufactured For: DURVET, INC.<br/>Blue Springs, MO U.S.A. www.durvet.com</paragraph>
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                     <content styleCode="bold">Not for Use in Humans • Keep Out of Reach of Children</content>
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               <title>Net Contents: </title>
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                  <paragraph>1 L (33.81 oz)</paragraph>
                  <paragraph>4 L (1.06 gallon)</paragraph>
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