<text/> <effectiveTime value="20210505"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="46066-800" codeSystem="2.16.840.1.113883.6.69"/> <name>Ivermax </name> <formCode code="C42967" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PASTE"/> <asEntityWithGeneric> <genericMedicine> <name>Ivermectin</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="91" unit="ug"/> <denominator value="6.08" unit="g"/> </quantity> <ingredientSubstance> <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/> <name>IVERMECTIN</name> <activeMoiety> <activeMoiety> <code code="8883YP2R6D" codeSystem="2.16.840.1.113883.4.9"/> <name>IVERMECTIN</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="6.08" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="46066-800-01" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43204" displayName="SYRINGE, PLASTIC" 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="20160921"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANADA200326" 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="Ld5e5a36a-ed9c-47fe-ba9c-fc8ae4fb8575"> <id root="60aea61b-36df-4dae-9626-fb02b70a7779"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">Ivermax<sup>®</sup> </content> <content styleCode="bold"/> </paragraph> <paragraph> <content styleCode="bold">(ivermectin paste) 1.87%</content> <content styleCode="bold"/> </paragraph> <paragraph> <content styleCode="bold">For Oral Use in Horses Only </content> </paragraph> <paragraph> <content styleCode="bold">Contents will treat up to 1250 lb body weight </content> </paragraph> <paragraph> <content styleCode="bold">Removes worms and bots with a single dose</content> <content styleCode="bold"/> <content styleCode="bold">Anthelmintic and Boticide</content> <content styleCode="bold"/> <content styleCode="bold">Approved by FDA under ANADA # 200-326 </content> <content styleCode="bold"/> </paragraph> <paragraph> <content styleCode="bold">Net Wt 0.21 oz (6.08 g)</content> <content styleCode="bold"/> </paragraph> <paragraph> <content styleCode="bold">First Companion Veterinary Products</content> </paragraph> <paragraph> <content styleCode="bold">Manufactured for: Aspen Veterinary Resources, Ltd.</content> </paragraph> <paragraph/> <paragraph/> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L53cb7a24-6a21-4762-ac1f-661daa4d4de0"> <id root="2a74c084-5fa9-475c-8cae-33af1f817d92"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS</content>: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermax (ivermectin paste) provides effective treatment and control of the following parasites in horses. <content styleCode="bold">Large Strongyles </content>(adults)- <content styleCode="italics">Strongylus vulgaris </content>(also early forms in blood vessels), <content styleCode="italics">S. edentatus</content> (also tissue stages), <content styleCode="italics">S. equinus</content>, <content styleCode="italics">Triodontophorus</content> spp. including <content styleCode="italics">T. brevicauda</content> and <content styleCode="italics">T. serratus</content> and <content styleCode="italics">Craterostomum 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. coronatus</content>, <content styleCode="italics">C. labiatus</content> and <content styleCode="italics">C. labratus, Cyathostomum</content> spp. including <content styleCode="italics">C. catinatum </content>and <content styleCode="italics">C. pateratum, Cylicocyclus</content> spp. including <content styleCode="italics">C. insigne</content>, <content styleCode="italics">C. leptostomum, C. nassatus</content>, and <content styleCode="italics">C. brevicapsulatus, Cylicodontophorus</content> spp., <content styleCode="italics">Cylicostephanus</content> spp. including <content styleCode="italics">C. calicatus, C. goldi, C. longibursatus</content> and <content styleCode="italics">C. minutus,</content> and <content styleCode="italics">Petrovinema 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 equi</content>; <content styleCode="bold">Ascarids</content> (adults and third- and fourth-stage larvae)- <content styleCode="italics">Parascaris equorum</content>; <content styleCode="bold">Hairworms</content> (adults)-<content styleCode="italics">Trichostrogylus axei</content>; <content styleCode="bold">Large-mouth Stomach Worms</content> (adults)- <content styleCode="italics">Habronema muscae</content>; <content styleCode="bold">Bots</content> (oral and gastric stages)-<content styleCode="italics">Gasterophilus </content>spp. including <content styleCode="italics">G. intestinalis</content> and <content styleCode="italics">G. nasalis</content>; <content styleCode="bold">Lungworms</content> (adults and fourth-stage larvae)- <content styleCode="italics">Dictyocaulus arnfieldi</content>; <content styleCode="bold">Intestinal Threadworms<content styleCode="italics"/> </content>(adults)- <content styleCode="italics">Strongyloides westeri;</content> <content styleCode="bold">Summer Sores<content styleCode="italics"/> </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> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L1e6ace46-3e20-407c-b84e-2279e031386a"> <id root="4e2da65e-448a-4c01-8a53-fb2dc6c9dcce"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DOSAGE</content>:  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>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> <paragraph/> <paragraph> <content styleCode="bold">PARASITE CONTROL PROGRAM:</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.  Ivermax (ivermectin paste) effectively controls gastrointestinal nematodes and bots of horses.  Regular treatment will reduce the chances of verminous arteritis caused by <content styleCode="italics">Strongylus vulgaris</content>.</paragraph> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L729064b7-de13-45f4-bf02-3027aafe1a87"> <id root="bbd141df-2c89-4884-a817-7548649092f2"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <text> <paragraph> <content styleCode="bold">PRODUCT ADVANTAGES:  Broad-spectrum Control - </content>Ivermax kills important internal parasites, including bots and the arterial stages of <content styleCode="italics">S. vulgaris</content>, with a single dose.  Ivermax is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.</paragraph> <paragraph/> <paragraph> <content styleCode="bold">ANIMAL SAFETY:  </content>Ivermax (ivermectin paste) 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> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L90c7eb01-0886-45ae-a036-1b2acfcf3769"> <id root="121d12a8-8772-4939-8ad9-cd1f88a00dda"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph> <content styleCode="bold">STORAGE INFORMATION: </content>Store at<content styleCode="bold"/>68°F - 77°F (20°C - 25°C). Excursions between 59°F - 86°F (15°C - 30°C) are permitted.</paragraph> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="Ldfa89667-0bde-4d73-a1c9-2efed3a06333"> <id root="81c64a2a-101a-44c9-9d0a-d37c0b99fcfa"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <table width="672px" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top"> <paragraph> <content styleCode="bold">ADMINISTRATION</content> </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics">(1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking, aligning the arrow on the ring to the line between the weight and lbs, as shown in the pictogram.  <br/> (2) Lock the ring in place by making a 1/4 turn to the right.  Ensure it is locked (it should no longer slide).</content> </content> <br/> (3) Make sure that the horse's mouth contains no feed.  <br/> (4) Remove the cover from the tip of the syringe.  <br/> (5) Insert the syringe tip into the horse's mouth at the space between the teeth.  <br/> (6) Depress the plunger as far as it will go, depositing paste on the back of the tongue.  <br/> (7) Immediately raise the horse's head for a few seconds after dosing.<content styleCode="bold"/> </paragraph> </td> <td valign="top"> <renderMultiMedia referencedObject="Le072a3a2-e43c-4375-85c5-b91f79e57e83"/> </td> </tr> </tbody> </table> <paragraph/> </text> <effectiveTime value="20210505"/> <component> <observationMedia ID="Le072a3a2-e43c-4375-85c5-b91f79e57e83"> <text>image description</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="IVERMAX plunger.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="L903237ef-da57-4c22-8daa-f5cf05f2d0f6"> <id root="81b92bc6-ea47-4ce5-8c4e-07f7d6b3ec2b"/> <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">WARNING:  Do not use in horses intended for human consumption.</content> </paragraph> <paragraph> <content styleCode="bold">Not for use in humans.  Keep this and all drugs out of reach of children.</content>  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 suspected adverse drug events, for technical assistance, or to obtain a copy of the 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-VETS or www.fda.gov/reportanimalae.</paragraph> <paragraph/> <paragraph> <content styleCode="bold">PRECAUTIONS: </content>Ivermax (ivermectin paste) 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/> <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> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="Lf9c664d5-6c72-4a59-a190-4674c80df08c"> <id root="d6779694-6715-4137-b5b4-8128d88301d5"/> <code code="50742-6" codeSystem="2.16.840.1.113883.6.1" displayName="ENVIRONMENTAL WARNING SECTION"/> <text> <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> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L4d908ae9-4a1c-40c5-b185-5f5f496748e4"> <id root="5961717d-cebf-4475-9324-b1b667c01819"/> <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 Ivermax (ivermectin paste) have occurred in horses carrying heavy infections of neck threadworm (<content styleCode="italics">Onchocerca</content> sp.) microfilariae.  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 Ivermax.  Reinfection, and measures for its prevention, should also be considered.  Consult your veterinarian if the condition does not improve.</paragraph> </text> <effectiveTime value="20210505"/> </section> </component> <component> <section ID="L7207abfd-2b5a-402f-bf3e-a56b820e5aeb"> <id root="4ffac62d-0eb9-42e3-8b0e-c7dd5a9c752b"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="Lf4149b86-fa89-4f02-b6e8-14e21d0a3742"/> </paragraph> </text> <effectiveTime value="20210505"/> <component> <observationMedia ID="Lf4149b86-fa89-4f02-b6e8-14e21d0a3742"> <text>image description</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="IVERMAX carton.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>