Valbazen

Dosage Form: FOR ANIMAL USE ONLY
Valbazen®

(albendazole)

Broad-Spectrum Dewormer

Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment of adult liver flukes in nonlactating goats

Active Ingredient:
Albendazole (Equivalent to 113.6 mg/mL)	11.36%

Indications

Cattle and sheep

Valbazen is a broad-spectrum anthelmintic effective in the removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms as indicated below.

Goats

For the treatment of adult liver flukes in nonlactating goats.

Parasite	Cattle	Sheep	Goats
Adult Liver Flukes	Fasciola hepatica	Fasciola hepatica, Fascioloides magna	Fasciola hepatica
Heads and Segments of Tapeworms	Moniezia benedeni, M. expansa	Common Tapeworm (Moniezia expansa), Fringed Tapeworm (Thysanosoma actinioides)
Adult and 4th Stage Larvae of Stomach Worms	Brown Stomach Worm, including 4th stage inhibited larvae (Ostertagia ostertagi), Barberpole Worm (Haemonchus contortus, H. placei), Small Stomach Worm (Trichostrongylus axei)	Brown Stomach Worm (Ostertagia circumcinta, Marshallagia marshalli), Barberpole Worm (Haemonchus contortus), 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, C. oncophora)	Thread-necked Intestinal Worm (Nematodirus spathiger, N. filicollis), Cooper's Worm (Cooperia oncophora), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum columbianum), Large-mouth Bowel Worm (Chabertia ovina)
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
Adult and Larval Stages of Lungworms		Dictyocaulus filaria

Dosage and Administration

Valbazen Suspension should be administered to cattle and goats at the recommended rate of 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg) and to sheep at the recommended rate of 0.75 mL/25 lb of body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg). The following table indicates recommended dosing schedules.

Cattle		Sheep		Goats
Body Weight	Dosage	Body Weight	Dosage	Body Weight	Dosage
250 lb	10 mL	25 lb	0.75 mL	25 lb	1 mL
500 lb	20 mL	50 lb	1.5 mL	50 lb	2 mL
750 lb	30 mL	75 lb	2.25 mL	75 lb	3 mL
1000 lb	40 mL	100 lb	3.0 mL	100 lb	4 mL
1250 lb	50 mL	200 lb	6.0 mL	125 lb	5 mL
1500 lb	60 mL	300 lb	9.0 mL	150 lb	6 mL

Cattle: 1 liter of Valbazen 11.36% Suspension will treat 50 animals weighing 500 lb.

Sheep: 1 liter of Valbazen 11.36% Suspension will treat 664 animals weighing 50 lb.

Goats: 1 liter of Valbazen 11.36% Suspension will treat 500 animals weighing 50 lb.

Valbazen 11.36% Suspension should be given orally using any type of standard dosing gun or dose syringe.

Important: Accurate estimates of the weight of the cattle, sheep, and goats to be treated are essential for most effective results with this product. Animals constantly exposed to internal parasites should be retreated as necessary.

ResidueWarnings

Cattle must not be slaughtered within 27 days following last treatment. Sheep and Goats must not be slaughtered within 7 days following last treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in lactating does.

Precaution

Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Do not administer to ewes or does during the first 30 days of pregnancy or for 30 days after removal of rams or bucks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Keep This and All Medication Out of Reach of Children

Shake Well Before Using

For Use in Animals Only

Store at Controlled Room Temperature 15°–30°C (59°–86°F)

Protect From Freezing

Not for human use

Restricted Drug (California) - Use only as directed

Distributed by:

Pfizer Animal Health

Div. of Pfizer Inc

NY, NY 10017

8784000

81551562

10361400

81608297, R.0

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

Valbazen®

(albendazole)

Broad-Spectrum Dewormer

Oral Suspension for Use in Cattle, Sheep, and Goats

for removal and control of liver flukes, tapeworms,

stomach worms (including 4th stage inhibited larvae of

Ostertagia ostertagi), intestinal worms, and lungworms

in cattle and sheep and for the treatment of adult liver

flukes in nonlactating goats

Active Ingredient:

Albendazole. . . . . . . . . . . . . . . . . . . . . . . . . 11.36%

(Equivalent to 113.6 mg/mL)

500 mL/16.9 fl oz (1 pt 1 fl oz)

NADA #110-048, Approved by FDA

Pfizer

Valbazen  albendazole  suspension

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61106-8783 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength albendazole (albendazole) albendazole 113.6 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61106-8783-3 500 mL In 1 BOTTLE, PLASTIC None 2 61106-8783-4 1000 mL In 1 BOTTLE, PLASTIC None 3 61106-8783-5 5000 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA110048	06/13/1989

Labeler - Pfizer Animal Health (039055157)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Animal Health		039055157	MANUFACTURE

Revised: 08/2010Pfizer Animal Health