| Printable Version |
NADA Number: 140-841 | |
| Proprietary Name |
Ivomec® Pour-On For Cattle |
|---|---|
| Sponsor |
Merial Ltd. |
| Sponsor Address |
3239 Satellite Blvd. Bldg. 500 Duluth, GA 30096-4640 USA |
| Ingredients |
Ivermectin |
| Species |
Cattle, beef Cattle, dairy, not breeding age |
| Routes of Administration |
Topical |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
OTC |
| Patent Number |
4199569* |
| Exclusivity |
This OTC approval is for the treatment and control of the following parasites in bovine (not for use in female dairy cattle of breeding age): Gastrointestinal roundworms (Ostertagia ostertagi, adult, fourth stage larvae and inhibited fourth stage larvae; Haemonchus placei; Trichostrongylus axel, T.
colubriformis; Cooperia spp.; Oesophagostomum radiatum, O.
venulosum, adults; Strongyloides papillosus, adults; Trichuris spp, adults); Lungworms (Dictyocaulus viviparus, adults and fourth stage larvae); Cattle Grubs (Hypoderma bovis; H. lineatum, parasitic stages); Lice (Linognathus vituli; Haematopinus eurysternus; Damalinia bovis; Selenopotes capillatus); Mites (Chorioptes bovis; Salutes scabei var. bovis; Horn flies (Haematobia irritans). The product is approved in liquid form to be applied topically. Granted for the use of ivermectin to prevent re-infection with Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; C. surnabada for 14 days after treatment; and Damalinia bovis for 56 days after treatment. Granted for new claims for the persistent control of gastrointestinal roundworms. |
| Withdrawal Time |
Cattle: 48 days before slaughter. A withdrawal time for pre-ruminating veal calves has not been established |
|
Dosage Amount, Indications & Limitations |
524.1193 Ivermectin pour-on. Specifications: Each milliliter of solution contains 5 milligrams of ivermectin. Conditions of use: Cattle Amount: One milliliter per 22 pounds of body weight. Indications: It is used topically for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia species, Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides papillosus, Trichuris species; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; horn flies Haematobia irritans. It also controls infections and prevents reinfection with O. radiatum and D. viviparus for 28 days after treatment, C. punctata and T. axei for 21 days after treatment, H. placei, C. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment. Limitations: Do not treat cattle within 48 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 on preruminating cales. Do not use on 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 |
Green Book Links
