	Printable Version

Proprietary Name	Ivomec® Plus Injection For Cattle Ivomec® F Injection For Cattle
NADA Number: 140-833
Sponsor	Merial Ltd.
Sponsor Address	3239 Satellite Blvd. Bldg. 500 Duluth, GA 30096-4640 USA
Ingredients	Ivermectin Clorsulon
Species	Cattle, dairy, not breeding age Cattle, beef, excluding veal calves
Routes of Administration	Subcutaneous
Dose Form	Liquid (solution)
Drug Form	Liquid (solution)
Merial Ltd. Has Pioneered:	Normectin® Plus Norbrook Laboratories Ltd.
Dispensing Status	OTC
Patent Number	4064239 4199569* 4853372
Exclusivity	Granted for the persistent control of gastrointestinal roundworms and lungworms following use of ivermectin and clorsulon injection for cattle. This OTC approval is for the treatment and control of infections caused by certain gastrointestinal nematodes, lungworms, liver flukes, grubs, lice, and mites in bovine (not for use in dairy cows). The product is approved in liquid form in concentrations of I: 1%; C: 10% and is to be administered subcutaneously. Granted extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days for beef cattle and dairy cattle under 20 months. Granted for the an increased period of protection from re-infection with three species of internal parasites, Oesophagostomum radiatum for 28 days after treatment and Cooperia punctata and Trichostrongylus axei for 21 days after treatment.
Withdrawal Time	Cattle: 49 days before slaughter.
Dosage Amount, Indications & Limitations	522.1193 Ivermectin and clorsulon injection. Specifications: Each milliliter of sterile aqueous solution contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10 percent) of clorsulon. Conditions of use: Cattle Amount: 1 milliliter (10 milligrams of ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110 pounds). For subcutaneous use. Indications: It is used 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); liver flukes (adults only) (Fasciola hepatica); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). It is also used to control infections of D. viviparus and O. radiatum for 28 days after treatment and O. ostertagi, T. axei and C. punctata for 21 days after treatment, and H. placei and C. oncophora, for 14 days after treatment. Limitations: For subcutaneous use only. Not for intravenous or intramuscular use. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
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 Tolerances are established for residues of clorsulon in cattle as follow: Kidney (the target tissue): The tolerance for parent clorsulon (the marker residue) is 1.0 part per million. Muscle. The tolerance for parent clorsulon (the marker residue) is 0.1 part per million.