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Oxytocin

Teva Animal Health, Inc.
Teva Animal Health, Inc.

Oxytocin Injection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

For uterine-contracting and milk-releasing action.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NADA 99-169, Approved by FDA

Net Contents: 100mL

Each mL Contains:

Oxytocic Activity Equivalent to 20 USP Posterior Pituitary units with Sodium Hydroxide/Acetic Acid for pH adjustment.

Chlorobutanol (as preservative)....................2.4mg

Water for Injection.......................................q.s.

STORAGE:

Store at controlled room temperature 20-25°C (68°-77°F).

Note: As this is a multi-dose container, this preparation should be handled under aseptic conditions.

Hazardous-Not for human use (California)

DO NOT FREEZE.

INDICATIONS:

Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state

OXYTOCIN DOSAGE AND ADMINISTRATION

(INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS)

For obstetrical use: U.S.P Units

Horses and Cows.........................100 (5 mL)

Sows and Ewes.........................30-50 (1½ to 2½ mL)

For milk letdown: U.S.P. Units

Cows............................................10-20 (½ to 1 mL)

Sows..............................................5-20 (¼ to 1 mL)

CONTRAINDICATIONS:

Do not use in dystocia due to abnormal presentation of fetus until correction is accomplished.

PRECAUTIONS:

For prepartum usage, full relaxation of the cervix should be accomplished either naturally or by the administration of estrogen prior to oxytocin therapy.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL BOTTLE LABEL

Oxytocin

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL SHIPPER LABEL

Oxytocin

Oxytocin

Oxytocin INJECTION

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:59130-774
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
oxytocin OXYTOCIN 20 U

Inactive Ingredients

Ingredient Name Strength
chlorobutanol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59130-774-01 100 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA099169 2013-04-03


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