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NADA Number: 131-675

Proprietary Name Safe-Guard®
Sponsor Intervet, Inc.
Sponsor Address 556 Morris Ave.
Summit, NJ    07901
USA
Ingredients Fenbendazole
Species (Class) CATTLE (Cattle, excluding veal calves)
CERVIDAE (DEER AND KIN) (Hippotraginae)
CERVIDAE (DEER AND KIN) (Antelope, zoo or wildlife)
HORSES (NO USE CLASS STATED OR IMPLIED)
OVIS ( WILD SHEEP) (Rocky mountain bighorn sheep, no use class stated or implied)
SWINE (Swine, no use class stated or implied)
TURKEYS (Turkey, growing)
WILDLIFE (Goat, wildlife)
WILDLIFE (Swine, feral)
Routes of Administration ORAL
Dosage Form TYPE A MEDICATED ARTICLE
Dispensing Status OTC
Patent Number (Expiration Date) (No Expiration Date)
(No Expiration Date)
Exclusivity This supplement provides for the use of fenbendazole liquid Type C medicated feed for the removal and control of lungworm (Dictyocaulus viviparus) in cattle. Expiration Date: September 5, 2011
Withdrawal Time

Wildlife: Do not use 14 days before or during hunting season.

Cattle: Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves.

 


Specifications

Type A medicated articles conatianing 4 percent (18.1 grams per pound), 8 percent (36.2 grams per pound), and 20 percent (90.7 grams per pound) fenbendazole.


Dosage Amount,
Indications
& Limitations

Swine

Amount: Fenbendazole, 10 to 80 grams per ton (to provide 9 milligrams per kilogram of body weight) given over a 3- to 12-day period.

Indications: For the removal and control of: adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages-liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages-intestinal mucosal forms) whipworms (Trichuris suis; adult and larvae kidney worms (Stephanurus dentatus).

Limitations: Feed as sole ration.

Feral swine (Suis scrofa)

Amount: 3 mg/kg body weight per day for 3 days.

Indications: For removal and control of kidney worms (Stephanurus dentatus), roundworms (Ascaris suum), and nodular worms (Oesophagostomum dentatum).

Limitations. Use as complete feed.

Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae) (zoo and wildlife)

Amount: 2.5 mg/kg body weight per day for 3 days.

Indications: For removal and control of small stomach worms (Trichostrongylus species), thread necked intestinal worm (Nematodirus species), barberpole worm (Haemonchus species), and whipworm (Trichuris species)

Limitations. Use as complete feed.

Rocky mountain bighorn sheep (Ovis c. canadensis) (zoo and wildlife)

Amount: 10 mg/kg body weight per day for 3 days.

Indications: For removal and control Protostrongylus species.

Limitations. Use as complete feed.

Turkeys (growing)

Amount: 14.5 g/ton of feed.

Indications: For the removal and control of gastrointestinal worms: Round worms, adult and larvae (Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead).

Limitations: Feed continuously as the sole ration for 6 days.

Horses

Amount: 4540 grams per ton.

Indications: 5 milligrams per kilograms body weight (2.27 milligrams per pound) for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus species), small stryongyles (Cyathostomum species, Cylicocylus species, Cylicostephanus species) and pinworms (Oxyuris equi); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (Parascaris equorum).

Limitations: Do not use in horses intended for food.

Dairy and Beef Cattle

Amount: 5 mg/kg body weight (2.27 mg/lb)

Indications: For removal and control of: Lungworms (Dictyocaulus viviparus). stomach worms: barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei), Intestinal worms: Hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), Bankrupt worms (Trichostrongylus colubriformis), Nodular worms (Oesophagostomum radiatum).

Limitations: Feed as the sole ration or as a top dress for one day treatment or in free-choice Type C medicated feeds fed for 3 to 6 days. Do not use in calves to be processed for veal.

Tolerances

Fenbendazole: Tolerances for residues of fenbendazole in food are established as follows:

a. Cattle 1) Muscle. The tolerance for parent fenbendazole (the marker residue) is 0.4 ppm. 2) In milk. The tolerance for fenbendazole sulfoxide metabolite (the marker residue in cattle milk) is 0.6 ppm.

b. Swine 1) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 6 ppm. 2) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 ppm.

c. Goats 1) Liver. The tolerance for parent fenbendazole (the marker residue) is 0.8 ppm. 1) Muscle. The tolerance for parent fenbendazole (the marker residue) is 0.4 ppm.

d. Turkeys 1) Liver. The tolerance for parent fenbendazole (the marker residue) is 6 ppm. 2) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 ppm.