OVUPROST INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLOPROSTENOL AS THE SODIUM SALT

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

cloprostenol as Na salt(250ug/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CLOPROSTENOL AS THE SODIUM SALT PROSTAGLANDIN Active 250.0 ug/ml

Units in package:

100 mL; 20 mL

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

COW | HORSE MARE (FEMALE) | BOVINE | FEMALE CATTLE | FEMALE HORSE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

CONTROL OF OESTRUS | CYSTIC OVARIES | EARLY FOETAL DEATH | EXTENDED DIOESTRUS | INDUCE ABORTION | INDUCTION OF PARTURITION | LACTATION ANOESTRUS | PSEUDO-PREGNANCY | PYOMETRA | SUB OESTRUS | SYNCHRONISATION OF OESTRUS | INDUCTION OF CALVING | PROLONGED WEANING TO MATING | PSEUDO-CYESIS | PSEUDO-PREGNANCY LACTATION | SILENT HEAT

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT: (COWS): DO NOT USE less than 1 day before slaughter for human consump tion. MILK: Zero (0) days ESI: EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this product. Note – observing the meat withholding period may not be sufficient to mitigate poten tial risks to export trade. Trade advice should be sought from Elanco Australasi a Pty Ltd on 1800 995 709 before using t his product.; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; HORSE MARE (FEMALE): [CONTROL OF OESTRUS, EARLY FOETAL DEATH, EXTENDED DIOESTRUS, INDUCE ABORTION, LACTATION ANOESTRUS, PSEUDO-PREGNANCY, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT: (COWS): DO N OT USE less than 1 day before slaughter for human consumption. MILK: Nil MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED in horses intended for human cons umption. EXPORT SLAUGHTER INTERVAL (ESI ): This product does not have an ESI e stablished. For advice on the ESI, cont act the manufacturer on 02 9987 4922 be fore using the product.; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; HORSE MARE (FEMALE): [CONTROL OF OESTRUS, EARLY FOETAL DEATH, EXTENDED DIOESTRUS, INDUCE ABORTION, LACTATION ANOESTRUS, PSEUDO-PREGNANCY, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; Poison schedule: 4; Withholding period: ; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; HORSE MARE (FEMALE): [CONTROL OF OESTRUS, EARLY FOETAL DEATH, EXTENDED DIOESTRUS, INDUCE ABORTION, LACTATION ANOESTRUS, PSEUDO-PREGNANCY, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; For luteolysis of functional corpora lutea in cows and mares.NOT for use in pregnant animals when abortion or induced parturition is NOT the objective. NOT for intravenous administration. NOT for use in mares suffering from acute or subacute disorders of the gastrointestinal or respiratory system.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
OVUPROST INJECTION
63034/138410
Label Name:
OVUPROST INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
250 µg/mL CLOPROSTENOL (as the sodium salt)
Claims:
For luteolysis of functional corpora lutea in cows and mares.
Net Contents:
20 mL
100 mL
Directions for Use:
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
Contraindicated for use in pregnant animals when abortion or induced
parturition is not the
objective.
Contraindicated for intravenous administration.
Contraindicated for use in mares suffering from acute or subacute
disorders of the
gastrointestinal or respiratory system.
Precautions:
Side Effects:
Occasional side effects have been observed following intramuscular
administration of PGs.
Such effects are generally transient and have little detrimental
effect on the animal.
In cattle, increased body temperature and salivary secretion has been
reported, usually
associated with the administration of 5-10 times the recommended dose.
Experimental RLP APPROVED
administration of 50-100 times the recommended dose to cattle resulted
in signs of
uneasiness, salivation and milk let down, but no other adverse
effects.
In mares, sweating, increased respiratory and heart rates, ataxia,
watery diarrhoea and
signs of mild abdominal pain have been observed. Such reactions have
usually resulted
from doses in excess of that recommended, and are generally mild and
transient.
Dosage and
Administration:
Use within 28 days of broaching the vial or flexipack, or discard the
unused portion.
Cows: single or repeat doses of 2 mL by intramuscular injection in the
anterior half of the
neck.
Mares: Less than 400 kg bodyweight: 0.5-1 mL by intramuscular
injection; Greater than 400
kg bodyweight: 1-2 mL by intramuscular injection.
General Directions:
DESCRIPTION:
Ovuprost Injection is a clear, sterile aqueous solution containing 250
µg/mL of cloprostenol
(

Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET 

A18317/02/AUS

OVUPROST INJECTION 

SECTION 1 – IDENTIFICATION, CONTACTS  

Bayer Australia Ltd 
875 Pacific Highway  
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER  
1800 033 111  
24 hour Emergency Service Australia Wide, Toll Free 

CONTACT POINT (FOR NON-EMERGENCY CALLS)  
Animal Health Division 
[phone]  
Full Product Name 
OVUPROST INJECTION 
Other Names 
None allocated

Product Use 
FOR ANIMAL TREATMENT ONLY 
For luteolysis of functional corpora lutea in cows and mares 
Creation Date 
April 2013

Revision Date 
2 October 2013 

SECTION 2 – HAZARDS IDENTIFICATION 
Hazard Classification 

NON- HAZARDOUS SUBSTANCE and 
NON- DANGEROUS GOODS According to the Criteria of NOHSC, 
and the ADG Code. 
Poisons Schedule 
S4 
Risk Phrases 
Nil 
Safety Phrases 
Nil 

SECTION 3 – COMPOSITION 
INGREDIENTS 
CAS NO 
PROPORTION 
W/V 
Cloprostenol (as sodium salt) 
55028-72-3 
0.025% 
This is a commercial product whose exact ratio
of components may vary slightly. Minor 
quantities of other non
hazardous ingredients are also present.  

A18317/02/AUS:  
OVUPROST INJECTION   

PAGE 2 OF 6 

SECTION 4 – FIRST AID MEASURES 
Label Regulated First 
Aid Statement 
If poisoning occurs contact a doctor or Poisons Information
Centre. 
Phone Australia 13 11 26. 
Scheduled Poisons 
S4 
Inhalation 
Move individual to fresh
air. If breathing ceases, give artificial 
respiration. Seek medical attention immediately. 
Skin contact 
If skin contact occurs, wash thoroughly with soap and water. 
Remove any contaminated clothing. If sprayed in mouth rinse 
mouth with water ensuring mouthwash is not swallowed. 
Eye contact 
If in eyes, hold eyes open, flood with water for at least 15
minutes. 
If irritation conti

Safety Data Sheet

100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_ACTIVE CONSTITUENT: _
_Cloprostenol _
_(as the sodium salt) _
_250µg/mL_
For luteolysis of
functional corpora lutea
in cows and mares.
Ovuprost
Injection
™
_ACTIVE CONSTITUENT: _
_Cloprostenol (as the sodium salt) 250 µg/mL_
For luteolysis of functional corpora lutea in
cows and mares.
100 ML
Ovuprost
Injection
™
100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_ACTIVE CONSTITUENT: _
_Cloprostenol _
_(as the sodium salt) _
_250µg/mL_
For luteolysis of
functional corpora lutea
in cows and mares.
Ovuprost
Injection
™
READ THE ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT
DIRECTIONS FOR USE:
Contraindicated for use in pregnant
animals when abortion or induced
parturition is not the objective.
Contraindicated for intravenous
administration.
Contraindicated for use in mares suffering
from acute or subacute disorders of the
gastrointestinal or respiratory system.
Use within 28 days of broaching the vial or
flexipack, or discard the unused portion.
COWS: single or repeat doses of 2mL by
intramuscular injection in the anterior half
of the neck.
MARES: less than 400kg bodyweight:
0.5-1mL by intramuscular injection;
Greater than 400kg bodyweight: 1-2mL by
intramuscular injection.
WITHHOLDING PERIODS:
MEAT: (COWS): DO NOT USE LESS THAN
1 DAY BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MILK: ZERO (0) DAYS
MEAT WITHHOLDING PERIOD (HORSES):
NOT TO BE USED IN HORSES INTENDED FOR
HUMAN CONSUMPTION.
TRADE ADVICE: EXPORT SLAUGHTER
INTERVAL (ESI): THIS PRODUCT DOES NOT
HAVE AN ESI ESTABLISHED. FOR ADVICE ON
THE ESI CONTACT THE MANUFACTURER ON
1800 678 368 BEFORE USING THIS PRODUCT.
FIRST AID: If poisoning occurs, contact a
doctor or Poisons Information Centre,
Australia 131126
DISPOSAL: Dispose of empty container
by wrapping with paper and putting in
garbage.
STORAGE: Store below 25°C
(air conditioning). Protect from light.
LIMITATION OF LIABILITY: Failure to use
the product strictly as directed may