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NADA Number: 128-409

Proprietary Name Ivomec® .27% Injection Grower And Feeder Pigs
Ivomec® 1% Injection for Cattle And Swine
Ivomec® 1% Injection
Ivomec® Injection for Cattle
Sponsor Merial Ltd.
Sponsor Address 3239 Satellite Blvd.
Bldg. 500
Duluth, GA    30096-4640
USA
Ingredients Ivermectin
Species (Class) BISON (Bison, American)
CATTLE (Cattle, dairy, not breeding age)
CATTLE (Cattle, beef, excluding veal calves)
CERVIDAE (DEER AND KIN) (Reindeer, no use class stated or implied)
DOGS (Fox, ranch)
SWINE (Swine, up to 70 pounds)
SWINE (Swine, no use class stated or implied)
Routes of Administration Subcutaneous
Dosage Form Liquid (solution)
Dispensing Status RX, OTC
Patent Number (Expiration Date) 4199569* (No Expiration Date)
4853372 (No Expiration Date)
Exclusivity Granted for the control of infection of Dictyocaulus viviparus and Ostertagia ostertagi for 21 days after treatment, and Oesophagostomum radiatum, Haemonchus placei, Trichostrongylus axei, Cooperia punctata, and Cooperia oncophora for 14 days after treatment in cattle.
Granted for the use in cattle to provide for the extension of the period of persistent effects on Oesophagostomum radiatum from 14 days to 28 days, and for Trichostrongylus axei and Cooperia punctata from 14 days to 21 days.
Granted to extend the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days after treatment in cattle, swine, reindeer, American bison, and ranch raised fox.
Withdrawal Time Cattle excluding veal: 35 days before slaughter. Swine: 18 days before slaughter. Reindeer: 56 days before slaughter. Bison: 56 days before slaughter. Milk: no withdrawal has been established.
Dosage Amount,
Indications
& Limitations

522.1192 Invermectin injection.

Specifications: Cattle, swine, and reindeer: each milliliter of sterile aqueous solution contains 10 milligrams of ivermectin (1 percent). Piglets 70 pounds or less and ranch-raised foxes: each milliliter of sterile aqueous solution contains 2.7 milligrams of ivermectin (0.27 percent).

Conditions of use:

Cattle, excluding veal calves

Amount: 200 micrograms per kilogram of body weight.

Indications: For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). To control infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

Limitations: Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Not for intravenous or intramuscular use. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Dose by subcutaneous injection.

Reindeer

Amount: 10 milliliters per 50 kilograms (110 ponds) body weight subcutaneously.

Indications: It is used in reindeer for treatment and control of warbles (Oedemagena tarandi).

Limitations: For subcutaneous use only. Not for intramuscular use. Do not treat reindeer within 56 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Swine

Amount: 300 micrograms per kilogram (2.2 pounds) subcutaneously.

Indications: Used in swine for treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var. suis).

Limitations: For subcutaneous injection in the neck of swine only. Do not treat swine within 18 days of slaughter. Do not use in other animal species as severe adverse reactions including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Ranch-raised foxes

Amount: 200 micrograms per kilogram body weight subcutaneously. Repeat in 3 weeks.

Indications: For treatment and control of ear mites (Otodectes cynotis).

Limitations: For subcutaneous use only. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

American bison

Amount: 200 micrograms per kilogram (10 milligrams per 110 pounds) of body weight subcutaneously.

Indications: It is used in American bison for the treatment and control of grubs (Hypoderma bovis).

Limitations: For subcutaneous use. Do not slaughter within 56 days of last treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Tolerances

Ivermectin:

A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 1.6 parts per million. 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 0.65 parts per million