	Printable Version

Proprietary Name	Valbazen®
NADA Number: 110-048
Sponsor	Pfizer, Inc.
Sponsor Address	235 East 42d St. New York, NY 10017 USA
Ingredients	Albendazole
Species	Sheep, restricted during pregnancy Cattle, beef Cattle, dairy, excluding female breeding age animals Cattle, restricted during pregnancy
Routes of Administration	Per Os
Dose Form	Liquid (suspension)
Drug Form	Liquid (suspension)
Dispensing Status	OTC
Exclusivity	Seven year period of marketing exclusivity granted for the use of albendazole in the treatment of nonlactating goats for adult liver fluke (Fasciola hepatica).
Withdrawal Time	Cattle: 27 days before slaughter Sheep: 7 days before slaughter Goats: 7 days before slaughter
Dosage Amount, Indications & Limitations	520.45a Albendazole suspension. Specifications: The product contains 11.36 percent albendazole. Conditions of use: Cattle Amount: 4.54 milligrams per pound of body weight (10 milligrams per kilogram). Administer as a single oral dose using dosing gun or dosing syringe. Indications: For removal and control of the following internal parasites of cattle: adult liver flukes (Fasciola hepatica), heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi), barberpole worm (Haemonchus contortus, H. placei), small stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger, N. helvetianus), small intestinal worm (Cooperia punctata and C. oncophora)); adult stages of intestinal worms (hookworm (Bunostomum phlebotomum) bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus). Limitations: Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Specifications: The product contains 4.55 or 11.36 percent albendazole. Conditions of use: Sheep Amount: 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe. Indications for use: For removal and control of the following internal parasites of sheep: Adult liver flukes (Fasciola hepatica, Fascioloides magna); heads and segments of common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma actinoides); adult and fourth stage larvae of stomach worms (brown stomach worm (Ostertagia circumcincta and Marshallagia marshalli), barberpole worm (Haemonchus contortus), small stomach worm (Trichostrongylus axei)); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm (Trichostrongylus colubriformis), nodular worm (Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and larval stages of lungworms (Dictyocaulus filaria). Limitations: Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams. Conditions of use: Goats (non-lactating) Amount: 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe. Indications for use: For the treatment of adult liver flukes (Fasciola hepatica) in nonlactating goats. Limitations: Do not slaughter within 7 days of last treatment. Do not administer to does during first 30 days of pregnancy or for 30 days after removal of bucks.
Tolerances	Tolerances are established for residues of albendazole in uncooked edible tissues as follows: a. In cattle: the tolerance for the 2-aminosulfone metabolite (marker residue) in liver (target tissue) is 0.2 part per million and in muscle 0.05 part per million. b. In sheep: the tolerance for the 2-aminosulfone metabolite (marker residue) in liver (target tissue) is 0.25 part per million and in muscle of 0.05 part per million.