OXYTOCIN- oxytocin injection, solution 
Bimeda Inc., Division of Cross Vetpharm Group

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Oxytocin

(purified oxytocic principle)

INJECTION FOR HORSES, COWS, SOWS, & EWES

20 USP Units per mL

Sterile Aqueous Solution

HAZARDOUS

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) - Use Only as Directed

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

ANADA 200-328, Approved by FDA

DESCRIPTION: Oxytocin injection is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the pituitary gland of healthy domestic animals used for food by humans.

EACH mL CONTAINS: Oxytocin 20 USP Units,  0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection q.s. and pH adjusted to 3.0 to 5.0 with acetic acid.

ACTIONS: Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rhythmic contractions, although in some species the uterine cervix does not respond to oxytocin. The responsiveness of the uterine musculature to oxytocin varies greatly with the stage of the reproductive cycle. During the early phases of pregnancy the uterus is relatively insensitive to the effects of oxytocin, while in the late phases the sensitivity is markedly increased. Most authorities attribute this varying response to the varying levels of estrogen and progesterone during the course of pregnancy. Oxytocin also has been shown to exert a milk ejecting effect occasionally referred to as the galactogogic effect. The actual mechanism by which oxytocin stimulates the release of milk from the mammary glands is not know with certainty, but oxytocin is presumed to act on certain smooth muscle elements in the gland.

INDICATIONS: Because of the specific action of oxytocin upon the uterine musculature, it is recommended as an aid in the management of the following conditions:

1. To precipitate labor.

2. To accelerate normal parturition.

3. Postpartum evacuation of uterine debris.

4. Postoperative contraction of the uterus following a cesarean section and control of uterine hemorrhage.

Oxytocin will contract the smooth muscle cells of the mammary gland to induce milk let-down if the udder is in a proper physiological state.

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

PRECAUTIONS: Oxytocin is a potent preparation, accordingly, it should be administered with due caution. For prepartum usage full dilation of the cervix should be accomplished either naturally or through the administration of estrogen prior to oxytocin therapy.

DOSAGE AND ADMINISTRATION:                                                                                                                                                  

Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:

Ewes, Sows:

1.5 to 2.5mL......................30 to 50 USP Units

Cows, Horses:

5.0mL...............................100 USP Units

These dosages are recommended, and may be repeated as indicated.

Milk Let-down:

Inject aseptically by the intravenous, intramuscular or subcutaneous route

Cows:

0.5 to 1.0mL.....................10 to 20 USP Units

Sows:

0.25 to 1.0mL....................5 to 20 USP Units

These dosages are recommended and may be repeated as necessary.

Note: Oxytocin will not induce milk let-down unless the udder is in proper physiological state.

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

HOW SUPPLIED:

100mL multiple dose vials.

Store at controlled room temperature.

Protect from freezing.

image description

OXYTOCIN 
oxytocin injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-6013
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN 20 [USP'U]  in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61133-6013-2 100 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200328 05/24/2004
Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Establishment
Name Address ID/FEI Business Operations
Bimeda - MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture
Establishment
Name Address ID/FEI Business Operations
Hemmo Pharmaceutical Pvt. Ltd. 650515294 api manufacture
Establishment
Name Address ID/FEI Business Operations
Aspen Oss B.V. 491013870 api manufacture

Revised: 2/2015
Document Id: a5b80dfb-cb26-40bb-8de1-c72aa50b1f04
Set id: 29aa28ea-36ef-431c-af1d-4aeec4c0e82a
Version: 4
Effective Time: 20150219
 
Bimeda Inc., Division of Cross Vetpharm Group