Your browser does not support JavaScript! OXYTOCIN INJECTION, SOLUTION [BIMEDA INC., DIVISION OF CROSS VETPHARM GROUP]

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OXYTOCIN injection, solution
[Bimeda Inc., Division of Cross Vetpharm Group]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL Abbreviated New Animal Drug Application
Drug Label Sections

Oxytocin

(purified oxytocic principle)

INECTION 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. Oxytocin injection contains 20 USP Units of oxytocin and less than 0.4 units of presser activity per mL. Each mL of sterile solution also contains 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.

STORAGE:

Store at controlled room temperature.

Protect from freezing.

image description

OXYTOCIN 
oxytocin injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61133-6013
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYTOCIN (OXYTOCIN) OXYTOCIN20 [USP'U]  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61133-6013-2100 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20032805/24/2004
Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda - MTC Animal Health, Division of Cross Vetpharm Group256232216manufacture
Establishment
NameAddressID/FEIBusiness Operations
GRINDEKS AS644702888api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Hemmo Pharmaceutical Pvt. Ltd.650515294api manufacture

Revised: 7/2013
 
Bimeda Inc., Division of Cross Vetpharm Group

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