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ANADA Number: 200-437

Proprietary Name Noromectin®
Sponsor Norbrook Laboratories Ltd.
Sponsor Address Station Works
Newry,    BT35 6JP
Northern Ireland
Ingredients Ivermectin
Pioneer 128-409 (Merial Ltd.)
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)
SWINE (Swine, no use class stated or implied)
SWINE (Swine, up to 70 pounds)
Routes of Administration Subcutaneous
Dosage Form Liquid (solution)
Dispensing Status OTC
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).

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.

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.

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: Do not treat swine within 18 days of slaughter.

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.

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