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   <title>IverCare Paste</title>
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                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="17135-740" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Ivermectin</name>
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                           <genericMedicine>
                              <name>ivermectin</name>
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                              <name>IVERMECTIN</name>
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                                    <name>IVERMECTIN</name>
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                              <numerator value="6.08" unit="g"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>Approved by FDA under ANADA # 200-390<br/>
                     <br/>
                     <content styleCode="italics">Anthelmintic and Boticide</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">For Oral Use in Horses Only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">Contents will treat up to 1250 lb body weight.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="italics">Removes worms and bots with a single dose.</content>
                  </paragraph>
                  <paragraph>Each Syringe Contains 0.21oz (6.08 g) Apple Flavor Ivermectin Paste</paragraph>
               </text>
               <effectiveTime value="20241204"/>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">INDICATIONS</content>: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin Paste provides effective treatment and control of the following parasites in horses. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Large Strongyles</content> (adults) – <content styleCode="italics">Strongylus</content>
                     <content styleCode="italics"> vulgaris</content> (also early forms in blood vessels), <content styleCode="italics">S</content>. <content styleCode="italics">edentatus</content> (also tissue stages), <content styleCode="italics">S</content>. <content styleCode="italics">equinus</content>, <content styleCode="italics">Triodontophorus</content> spp. including <content styleCode="italics">T</content>. <content styleCode="italics">brevicauda</content> and <content styleCode="italics">T</content>. <content styleCode="italics">serratus</content> and <content styleCode="italics">Craterostomum</content>
                     <content styleCode="italics"> acuticaudatum</content>; <content styleCode="bold">Small Strongyles</content> (adults, including those resistant to some benzimidazole class compounds) – <content styleCode="italics">Coronocyclus</content> spp. including <content styleCode="italics">C</content>. <content styleCode="italics">coronatus</content>, <content styleCode="italics">C</content>. <content styleCode="italics">labiatus</content> and <content styleCode="italics">C</content>. <content styleCode="italics">labratus</content>, <content styleCode="italics">Cyathostomum</content> spp. including <content styleCode="italics">C</content>. <content styleCode="italics">catinatum</content> and <content styleCode="italics">C</content>. <content styleCode="italics">pateratum</content>, <content styleCode="italics">Cylicocyclus</content> spp. including <content styleCode="italics">C</content>. <content styleCode="italics">insigne</content>, <content styleCode="italics">C</content>. <content styleCode="italics">leptostomum</content>, <content styleCode="italics">C</content>. <content styleCode="italics">nassatus</content> and <content styleCode="italics">C</content>. <content styleCode="italics">brevicapsulatus</content>, <content styleCode="italics">Cylicodontophorus</content> spp., <content styleCode="italics">Cylicostephanus</content> spp. including <content styleCode="italics">C</content>. <content styleCode="italics">calicatus</content>, <content styleCode="italics">C</content>. <content styleCode="italics">goldi</content>, <content styleCode="italics">C</content>. <content styleCode="italics">longibursatus</content> and <content styleCode="italics">C</content>. <content styleCode="italics">minutus</content>, and <content styleCode="italics">Petrovinema </content>
                     <content styleCode="italics">poculatum</content>; <content styleCode="bold">Small Strongyles</content> – Fourth-stage larvae; <content styleCode="bold">Pinworms</content> (adults and fourth-stage larvae) – <content styleCode="italics">Oxyuris</content>
                     <content styleCode="italics"> equi</content>; <content styleCode="bold">Ascarids</content> (adults and third- and fourth-stage larvae) – <content styleCode="italics">Parascaris</content>
                     <content styleCode="italics"> equorum</content>; <content styleCode="bold">Hairworms</content> (adults) – <content styleCode="italics">Trichostrongylus</content>
                     <content styleCode="italics"> axei</content>;  <content styleCode="bold">Large-mouth</content>
                     <content styleCode="bold"> Stomach </content>
                     <content styleCode="bold">Worms</content> (adults) – <content styleCode="italics">Habronema</content>
                     <content styleCode="italics"> muscae</content>; <content styleCode="bold">Bots</content> (oral and gastric stages) – <content styleCode="italics">Gasterophilus</content> spp. including <content styleCode="italics">G</content>. <content styleCode="italics">intestinalis</content> and <content styleCode="italics">G</content>. <content styleCode="italics">nasalis</content>; <content styleCode="bold">Lungworms</content> (adults and fourth-stage larvae) – <content styleCode="italics">Dictyocaulus</content>
                     <content styleCode="italics"> arnfieldi</content>; <content styleCode="bold">Intestinal</content>
                     <content styleCode="bold"> Threadworms</content> (adults) – <content styleCode="italics">Strongyloides</content>
                     <content styleCode="italics"> westeri</content>; <content styleCode="bold">Summer </content>
                     <content styleCode="bold">Sores</content> caused by <content styleCode="italics">Habronema</content> and <content styleCode="italics">Draschia</content> spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, <content styleCode="italics">Onchocerca</content> sp.</paragraph>
               </text>
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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:</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Ivermectin Paste Net Wt: 0.21 oz (6.08 g)</content>
                  </paragraph>
                  <paragraph>This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.</paragraph>
                  <paragraph>
                     <content>Do not underdose. </content>
                     <content>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.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">
                        <content>ADMINISTRATION:</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content>(1) While holding plunger, turn the knurled ring on the plunger to the right to move it up towards the barrel until the side nearest the barrel aligns with the line at the prescribed weight marking, as shown in the pictogram.   </content>
                     </content>
                  </paragraph>
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                  <paragraph>
                     <content styleCode="bold">
                        <content>(2) Ensure the ring is secured at the appropriate weight by turning the ring 1/4 turn to the left.</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content>(3) Make sure that the horse's mouth contains no feed. </content>
                  </paragraph>
                  <paragraph>
                     <content>(4) Remove the cover from the tip of the syringe. </content>
                  </paragraph>
                  <paragraph>
                     <content>(5) Insert the syringe tip into the horse's mouth at the space between the teeth. </content>
                  </paragraph>
                  <paragraph>
                     <content>(6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. </content>
                  </paragraph>
                  <paragraph>
                     <content>(7) Immediately raise the horse's head for a few seconds after dosing.</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">PARASITE CONTROL PROGRAM</content>
                     <content>: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Ivermectin Paste 1.87% effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by </content>
                     <content styleCode="italics">Strongylus</content>
                     <content styleCode="italics"> vulgaris</content>
                     <content>.</content>
                  </paragraph>
                  <paragraph>
                     <br/>
                     <content styleCode="bold">PRODUCT ADVANTAGES</content>: <content styleCode="bold">Broad-spectrum Control</content>–  Ivermectin Paste 1.87% kills important internal parasites, including bots and the arterial stages of <content styleCode="italics">S</content>. <content styleCode="italics">vulgaris</content>, with a single dose.  Ivermectin Paste 1.87% is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.<br/>
                     <br/>
                     <content styleCode="bold">ANIMAL SAFETY</content>: Ivermectin Paste 1.87% may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.</paragraph>
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                     <text>IverCare Syringe Handle</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">WARNING</content>: <content styleCode="bold">Do not use in horses intended for human consumption</content>.<br/>
                     <br/>
                     <content styleCode="bold">Not for use in humans. Keep this and all drugs out of reach of children.</content>
                     <br/>
                     <br/>Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a SDS, contact Farnam Companies, Inc. at (800) 234-2269.</paragraph>
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               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS</content>: Ivermectin Paste 1.87% has been formulated specifically for use in horses <content styleCode="bold">only</content>. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.</paragraph>
                  <paragraph>
                     <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.</paragraph>
                  <paragraph>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.</paragraph>
                  <paragraph>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, 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).</paragraph>
                  <paragraph>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.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Environmental Safety</content>: Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.</paragraph>
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               <code code="50744-2" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR OWNERS/CAREGIVERS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">INFORMATION FOR HORSE OWNERS</content>: Swelling and itching reactions after treatment with Ivermectin Paste 1.87% have occurred in horses carrying heavy infections of neck threadworm microfilariae (<content styleCode="italics">Onchocerca</content> sp.) . These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Ivermectin Paste 1.87%. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CONTACT INFORMATION: </content> To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Farnam Companies, Inc. at (800) 234-2269. </paragraph>
                  <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae</paragraph>
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                  <paragraph>
                     <content styleCode="bold">STORAGE INFORMATION:</content>  Store at 20°C to 25°C  (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).</paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Manufactured for:</content>
                     <br/>Farnam Companies, Inc.<br/>Phoenix, AZ 85013</paragraph>
                  <paragraph/>
                  <paragraph>IverCare is a registered trademark of Farnam Companies, Inc</paragraph>
                  <paragraph/>
                  <paragraph>Rev. 12/2024</paragraph>
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