Oxytocin

Bayer HealthCare LLC

Oxytocin Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

• Each mL Contains:
• STORAGE:
• INDICATIONS:
• OXYTOCIN DOSAGE AND ADMINISTRATION
• OXYTOCIN CONTRAINDICATIONS
• PRECAUTIONS
• PACKAGING/LABELING BOTTLE LABEL
• PACKAGING/LABELING SHIPPER LABEL

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)................................................2.4 mg

Water For Injection.........................................................................q.s.

STORAGE:

Store at controlled room temperature 20-25º C (68º-77ºF).

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:

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)

OXYTOCIN 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.

Manufactured for Bayer HealthCare LLC.

Shawnee Mission, KS 66201

81584788, R.0 200087.00

Bayer and the Bayer Cross are registered

trademarks of Bayer.

PACKAGING/LABELING BOTTLE LABEL

PACKAGING/LABELING SHIPPER LABEL