VALBAZEN- albendazole suspension

Valbazen by

Drug Labeling and Warnings

Valbazen by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

SPL UNCLASSIFIED SECTION

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

VETERINARY INDICATIONS

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), Barber Pole Worm (Haemonchus contortus, H. placei), Small Stomach Worm (Trichostrongylus axei)	Brown Stomach Worm (Ostertagia circumcincta, Marshallagia marshalli), Barber Pole 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 & ADMINISTRATION

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.

SPL UNCLASSIFIED SECTION

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.

RESIDUE WARNING

Residue Warnings: 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.

PRECAUTIONS

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.

SPL UNCLASSIFIED SECTION

Keep This and All Medication Out of Reach of Children

Shake Well Before Using

For Use in Animals Only

STORAGE AND HANDLING

Store at Controlled Room Temperature 20° – 25°C (68° – 77°F)

Protect From Freezing

Not for human use

Restricted Drug (California) - Use only as directed

SPL UNCLASSIFIED SECTION

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

8784000
13945200

LOT
EXP

PRINCIPAL DISPLAY PANEL - 1 L/33.8 fl oz 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
(equivalent to 113.6 mg/mL)
11.36%

1 L/33.8 fl oz (1 qt 1.8 fl oz)

NADA #110-048, Approved by FDA

8784000
13945100

zoetis

PRINCIPAL DISPLAY PANEL - 5 L/169 fl oz 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
(equivalent to 113.6 mg/mL)
11.36%

5 L/169 fl oz (1 gal 1 qt 9 fl oz)

NADA #110-048, Approved by FDA

8785000
13945600

zoetis

PRINCIPAL DISPLAY PANEL - 500 mL/16.9 fl oz 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
(Equivalent to 113.6 mg/mL)
11.36%

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

NADA #110-048, Approved by FDA

zoetis

INGREDIENTS AND APPEARANCE

VALBAZEN 
albendazole suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-8783
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
albendazole (UNII: F4216019LN) (albendazole - UNII:F4216019LN)	albendazole	113.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	6 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-8783-1	500 mL in 1 BOTTLE
2	NDC: 54771-8783-2	1000 mL in 1 BOTTLE
3	NDC: 54771-8783-3	5000 mL in 1 BOTTLE

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

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
Zoetis LLC		039055157	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
UQUIFA Mexico, S.A. DE C.V.		810105874	API MANUFACTURE