OVURELIN INJECTION

Država: Australija

Jezik: engleski

Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktivni sastojci:

GONADORELIN AS GONADORELIN ACETATE

Dostupno od:

ELANCO AUSTRALASIA PTY LTD

INN (International ime):

gonadorelin as acetate(100ug/mL)

Farmaceutski oblik:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sastav:

GONADORELIN AS GONADORELIN ACETATE HORMONE-GONADOTROPHIN Active 100.0 ug/ml

Jedinice u paketu:

100 mL; 20 mL

Razred:

VM - Veterinary Medicine

Proizveden od:

BAYER AUSTRALIA

Terapijska grupa:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Područje terapije:

ENDOCRINE SYSTEM

Terapijske indikacije:

CYSTIC OVARIES | DELAYED OVULATION | IMPROVEMENT OF POSTPARTUM FERTILITY | SYNCHRONISATION OF OESTRUS & OVULATION | POST-PARTUM FERTILITY

Proizvod sažetak:

Poison schedule: 4; Withholding period: MEAT: WITHHOLDING PERIODS: NIL MILK: WI THHOLDING PERIODS: NIL ESI: An ESI ha s not been established for this product. Note – observing the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice should be sought from Elanco Aust ralasia Pty Ltd on 1800 995 709 before u sing this product.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: MEAT: WITHHOLDING PERIODS: NIL MILK: WI THHOLDING PERIODS: NIL EXPORT SLAUGHT ER INTERVAL (ESI): The product does not have an ESI established. For advice on t he ESI, contact the manufacturer on 1800 995 709 before using this product.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: WHP: NIL ESI: THIS PRODUCT DOES NOT HA VE AN ESI ESTABLISHED. FOR ADVICE ON TH E ESI, CONTACT THE MANUFACTURER ON 02 9 987 4922 BEFORE USING THIS PRODUCT.; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [CYSTIC OVARIES, DELAYED OVULATION, IMPROVEMENT OF POSTPARTUM FERTILITY, SYNCHRONISATION OF OESTRUS & OVULATION]; For use in oestrus synchronisation programs in combination with PGF2a. For the treatment of cystic ovaries, prevention of delayed ovulation and improvement of postpartum fertility in cattle.

Status autorizacije:

Registered

Datum autorizacije:

2023-07-01

Uputa o lijeku

Product Name:
APVMA Approval No:
OVURELIN INJECTION
63035/138414
Label Name:
OVURELIN INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 μg/mL GONADORELIN AS ACETATE
Claims:
For use in oestrus synchronisation programs in combination with
PGF2α.
For the treatment of cystic ovaries, prevention of delayed ovulation
and improvement of
postpartum fertility in cattle.
Net Contents:
20 mL
100 mL
Directions for Use:
Restraints:
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
Discard all open vials 28 days after broaching.
Cattle: Injection to be given into the anterior half of the neck.
Cystic ovaries: 5 mL (500 µg gonadorelin) by intramuscular injection.
Prevention of delayed ovulation: 2.5 mL (250 µg gonadorelin) by
intramuscular injection.
Improvement of postpartum fertility: 2.5 mL (250 µg gonadorelin) by
intramuscular injection. RLP APPROVED
Oestrus synchronisation: 1 mL (100 µg gonadorelin) by intramuscular
injection, for
example:
Day 0
1 mL (100 µg gonadorelin)
Day 7
2 mL PGF2α
Day 9
1 mL (100 µg gonadorelin)
Insemination 8-24 hours after 2nd OVURELIN INJECTION.
General Directions:
DESCRIPTION:
OVURELIN INJECTION is a clear, colourless, sterile solution containing
100 µg/mL
of gonadorelin (as acetate). Gonadorelin is a synthetic decapeptide,
identical to the
endogenous Gonadotropin Releasing Hormone (GnRH), which controls the
production,
and secretion of Luteinising Hormone (LH) and Follicle Stimulating
Hormone (FSH) by the
pituitary gland. Both LH and FSH have a direct effect on the ovary:
FSH stimulates follicle
development, while LH induces ovulation and luteinisation. Injection
of gonadorelin acetate
induces the simultaneous release of FSH and LH thereby stimulating the
maturation of
ovarian follicles, ovulation and development of the corpus luteum.
INDICATIONS:
1. OESTRUS SYNCHRONISATION
Oestrus synchronisation protocols involving the use of Prostaglandin
F2α (PGF2α) and
Gonadotropin Rel

Svojstava lijeka

PAGE 1 OF 6

SAFETY DATA SHEET 

A18318/02/AUS

OVURELIN 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 
OVURELIN INJECTION 
Other Names 
None allocated

Product Use 
FOR ANIMAL TREATMENT ONLY 
For use in oestrus synchronisation programs in combination with 
PGF2
α, prevention of delayed ovulation and improvement of 
postpartum fertility and for the treatment
of cystic ovaries in cattle. 
Creation Date 
April 2013

Revision Date 
2 October 2013 

SECTION 2 – HAZARDS IDENTIFICATION 
Hazard Classification 

NON- HAZARDOUS SUBSTANCE 
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 
Gonadorelin diacetate tetrahydrate 
52699-48-6 
0.01% 
This is a commercial product whose exact ratio
of components may vary slightly. Minor 
quantities of other non
hazardous ingredients are also present.  

A18318/02/AUS:  
OVURELIN INJECTION   

PAGE 2 OF 6 

SECTION 4 – FIRST AID MEASURES 
Label Regulated First 
Aid Statement 
If poisoning occurs contact a doctor or the Poisons Information 
Centre. Phone Australia 13 11 26. 
Scheduled Poisons 
S4 
Inhalation 
Unlikely to occur. Move
individual to fresh air. If breathing ceases, 
give artificial respiration. Seek medical
attention if irritation occurs. 
Skin contact 
If skin contact occurs, wash thoroughly with soap and water. 
Remove any contaminated clothing. If sprayed in mouth rinse 
mo

Sigurnosni tehnički list

100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_ACTIVE CONSTITUENT: _
_Gonadorelin (as acetate) _
_100µg/mL_
For use in oestrus
synchronisation programs in
combination with PGF2
α
.
For the treatment of cystic
ovaries, prevention of delayed
ovulation and improvement of
postpartum fertility in cattle.
Ovurelin
Injection
™
100 ML
100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
_ACTIVE CONSTITUENT: _
_Gonadorelin (as acetate) _
_100µg/mL_
For use in oestrus
synchronisation programs in
combination with PGF2
α
.
For the treatment of cystic
ovaries, prevention of delayed
ovulation and improvement of
postpartum fertility in cattle.
Ovurelin
Injection
™
_ACTIVE CONSTITUENT: Gonadorelin (as acetate) 100µg/mL_
For use in oestrus synchronisation programs in
combination with PGF2
α
. For the treatment of cystic
ovaries, prevention of delayed ovulation and
improvement of postpartum
fertility in cattle.
Ovurelin
Injection
™
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
Discard all open vials 28 days after
broaching.
CATTLE: Injection to be given into the
anterior half of the neck.
CYSTIC OVARIES: 5mL (500µg
gonadorelin) by intramuscular injection .
PREVENTION OF DELAYED OVULATION:
2.5mL (250µg gonadorelin) by
intramuscular injection.
IMPROVEMENT OF POSTPARTUM FERTILITY:
2.5mL (250µg gonadorelin) by
intramuscular injection.
OESTRUS SYNCHRONIZATION: 1mL (100µg
gonadorelin) per dose by intramuscular
injection (see enclosed leaflet).
WITHHOLDING PERIODS:
MEAT, MILK: ZERO (0) DAYS
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.
L