| Printable Version |
NADA Number: 141-241 | |
| Proprietary Name |
Zimecterin-EZ™ |
|---|---|
| Sponsor |
Farnam Companies, Inc. |
| Sponsor Address |
301 West Osborn Phoenix, AZ 85013-3928 USA |
| Ingredients |
Ivermectin |
| Species |
Horse, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Top dressing in feed |
| Drug Form |
Meal |
| Dispensing Status |
OTC |
| Exclusivity |
Granted for the bioequivalence study which demonstrated comparable systemic ivermectin exposure when used in the animal as the approved paste, compared to the corn cob meal mixture formulation. |
|
Dosage Amount, Indications & Limitations |
520.1194 Ivermectin meal. Specifications: Each gram of meal contains 6 milligrams ivermectin (0.6 percent). Conditions of use: Horses Amount: Administer 136 micrograms ivermectin per pound of body weight (300 micrograms per kilogram) as a single dose on approximately 2 pounds grain or sweet feed. Indications: For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third- stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. Limitations: Do not use in horses intended for human consumption. |
| Tolerances |
A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion |
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