Panacure®-C (Rx) - Share Your Panacure®-C (Rx) Experience with Community:
blog comments powered by DisqusNADA Number: 121-473 | |
| Proprietary Name |
Panacure®-C (Rx) Safe-Guard® Canine (OTC) Panacur® Granules 22.2% (Rx) |
|---|---|
| Sponsor |
Intervet, Inc. |
| Sponsor Address |
29160 Intervet Lane P.O. Box 318 Millsboro, DE 19966 USA |
| Ingredients |
Fenbendazole |
| Species |
Black bear, zoo or wildlife Horse, not for meat production Grizzly bear, zoo or wildlife Cheetah, zoo or wildlife Lion, zoo or wildlife Panther, zoo or wildlife Tiger, zoo or wildlife Jaguar, zoo or wildlife Puma, zoo or wildlife Polar bear, zoo or wildlife Dog, no use class stated or implied Leopard, zoo or wildlife |
| Routes of Administration |
Per Os |
| Dose Form |
Top dressing in feed |
| Drug Form |
Granules |
| Dispensing Status |
RX, OTC |
| Exclusivity |
This supplemental application for these prescription-only granules provides for an additional claim as an anthelmintic in the following species within the families Felidae and Ursidae: lion (Panthera leo), tiger (Panthera tigris), cheetah (Acinonyx jubatus), puma (Felis concolor), jaguars (Panthera onca), leopard (Panthera pardus), panther (Panthera spp.), grizzly bear (Ursus horribilis), polar bear (Ursus maritimus), and black bear (Ursus americanus). |
| Withdrawal Time |
Wildlife: 14 days before or during hunting season. |
|
Dosage Amount, Indications & Limitations |
520.905b Fenbendazole granules. Specifications: The drug is in granular form containing 22 percent (222 milligrams per gram) fenbendazole. Conditions of use: Horses Amount 5 milligrams per kilogram (2.3 milligrams per pound) for the control of large strongyles, small strongyles, and pinworms; 10 milligrams per kilogram for the control of ascarids. Indications: For the control of infections of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi) and ascarids (Parascaris equorum) Limitations: Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Dogs Amount: 50 milligrams per kilogram (22.7 milligrams per pound) daily for 3 consecutive days. Indications: For the treatment and control of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis). Limitations: Mix the appropriate amount of drug with a small amount of the usual food. Dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Lion (Panthero leo) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species.) Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Tiger (Panthera Tigris) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species.) Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Cheetah (Acinonyx jubatus) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Puma (Felis concolor) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Panther (Panthera species) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Leopard (Panthera pardus) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Jaguar (Panthera onca) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma species.), Tapeworm (Taenia hydatigena, T. krabbei, T. taeniaeformis). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Black Bear (Ursus americanus) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Baylisascaris transfuga, Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia hydatigena, T. krabbei). Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Polar Bear (Ursus maritimus) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Baylisascaris transfuga, Toxascaris leonina) Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. Grizzly Bear (Ursus horribilis) Amount: Ten milligrams per kilogram per day for 3 days. Indications: For control of internal parasites of Felidae and Ursidae: Ascarid (Baylisascaris transfuga, Toxascaris leonina) Limitations: Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season. |
| Tolerances |
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. |