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NADA Number: 141-214

Proprietary Name Zimecterin® Gold Paste
Sponsor Merial Ltd.
Sponsor Address 3239 Satellite Blvd.
Bldg. 500
Duluth, GA    30096-4640
USA
Ingredients Ivermectin
Praziquantel
Species Horse, foals 2 months and older, not for food
Routes of Administration Per Os
Dose Form Paste
Drug Form Paste
Dispensing Status OTC
Patent Number 7001889
Exclusivity This supplemental application reduces the minimum age at which foals may be treated to 2 months from 5 months of age.
Granted for the use in horses to treat summer sores, some types of dermatitis, and the following internal parasites: tapeworms, large strongyles, pinworms, ascarids, hairworms, large-mouth stomach worms, bots, lungworms, and intestinal threadworms.
Dosage Amount,
Indications
& Limitations

520.1198 Ivermectin and praziquantel paste.

Specifications: Each milligram of paste contains 0.0155 milligram (1.55 percent) ivermectin and 0.0775 milligram (7.75 percent) praziquantel.

Conditions of use:

Horses

Amount: 200 microgram per kilogram ivermectin (91 [microgram per pound and 1 milligram per kilogram praziquantel (454 micrograms per pound) body weight.

Indications for use: For treatment and control of the following parasites in horses: tapeworms--Anoplocephala perfoliata; large strongyles (adults)-- Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus species including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; small strongyles (adults, including those resistant to some benzimidazole class compounds)--Coronocyclus species including C. coronatus, C. labiatus, and C. labratus, Cyathostomum species including C. catinatum and C. pateratum, Cylicocyclus species including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus species, Cylicostephanus species 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 species 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 species cutaneous third- stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca species.

Limitations: For oral use only. 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