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Valbazen

Zoetis Inc.

Valbazen Suspension


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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), 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 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.

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.

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 20° – 25°C (68° – 77°F)

Protect From Freezing

Not for human use

Restricted Drug (California) - Use only as directed

Valbazen

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

Valbazen

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

Valbazen

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

Valbazen

Valbazen

albendazole SUSPENSION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:54771-8783
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ALBENDAZOLE albendazole 113.6 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
POTASSIUM SORBATE
polysorbate 80
BENZOIC ACID

Packaging

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

Marketing Information

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


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