| Printable Version |
NADA Number: 110-048 | |
| Proprietary Name |
Valbazen® |
|---|---|
| Sponsor |
Zoetis, Inc. |
| Sponsor Address |
333 Portage St. Kalamazoo, MI 49007 |
| Ingredients |
Albendazole |
| Species (Class) |
ANIMAL SPECIES
(No Class Defined) CATTLE (Cattle, dairy, excluding female breeding age animals) CATTLE (Cattle, beef) CATTLE (Cattle, restricted during pregnancy) GOATS (NON-LACTATING) SHEEP (DOMESTIC) (Sheep, restricted during pregnancy) |
| Routes of Administration |
ORAL |
| Dosage Form |
LIQUID (SUSPENSION) |
| Dispensing Status |
OTC |
| Exclusivity |
Seven year period of marketing exclusivity granted for the use of albendazole in the treatment of adult liver fluke (Fasciola hepatica) in nonlactating goats for (1/24/2015).
|
| Withdrawal Time |
Cattle: 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. Sheep: Do not slaughter within 7 days of last treatment. Goats: Do not slaughter within 7 days of last treatment. |
| Specifications |
The product contains 11.36 percent albendazole. |
|
Dosage Amount, Indications & Limitations |
Cattle Dosage: 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg). 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. Sheep Dosage: 0.75 mL/25 lb of body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe. Indications: 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 administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams. Goats (non-lactating) Dosage: 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg). Administer as a single oral dose using dosing gun or dosing syringe. Indications: For the treatment of adult liver flukes (Fasciola hepatica) in nonlactating goats. Limitations: Do not administer to does during first 30 days of pregnancy or for 30 days after removal of bucks. Do not use in lactating does.
|
| Tolerances |
Albendazole: 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. |
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