OVSYNCH 1 INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

GONADORELIN AS GONADORELIN ACETATE

Available from:

PARNELL TECHNOLOGIES PTY LTD

INN (International Name):

gonadorelin as acetate(100ug/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

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

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

PARNELL TECHNOLOGIES

Therapeutic group:

DAIRY CATTLE | BOVINE | BREEDERS | CALVES | DAIRY COW | GROWERS | LACTATING COW | MILKING COW

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

SYNCHRONISATION OF OESTRUS

Product summary:

Poison schedule: 4; Withholding period: WHP:Meat:Nil Milk:Nil; Host/pest details: DAIRY CATTLE: [SYNCHRONISATION OF OESTRUS]; Poison schedule: 4; Withholding period: ; Host/pest details: DAIRY CATTLE: [SYNCHRONISATION OF OESTRUS]; For use in oestrus synchronisation programs in combination with PGF2a.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

100mL Label:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
OVSYNCH 1
INJECTION
ACTIVE CONSTITUENT:
GONADORELIN (as acetate) 100
J.l9/MI
FOR USE IN OESTRUS SYNCHRONIZATION PROGRAMS IN COMBINATION WITH PGF2A.
100
ml
RLP
Approved
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
Following withdrawal of the first dose, use the remainder
of
the vial within 28 days
or discard the unused portion.
Cattle:
Injection to
be
given into the anterior half of the neck.
Oestrus
synchronization:
1 mL
(1
0011g
Gonadorelin) per dose by intramuscular
injection. (See enclosed leaflet).
WITHHOLDING PERIODS: NIL.
TRADE ADVICE:
Export
Slaughter
Interval (ESI): This product does not have an
ESI
established. For advice
on
the ESI, contact the manufactuer
on
(02) 9667
4411
before using this product.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Center.
Phone Australia 131126.
PARNELL AUSTRALIA PTY LTD 4/476 Garderners Road, Alexandria NSW
2015
Dispose
of
empty container
by
wrapping with paper and putting
in
garbage.
Store between
zoe
and
soc
(Refrigerate.
Do
Not Freeze).Protect from light.
APVMA
No.
6329~
_156778 _
Infopest
Verified
100mL Carton:
READ
THE
ENCLOSED
LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
Following withdrawal of the first dose, use
the remainder
of
the vial within
28
days or
discard the unused portion.
Cattle:
Injection
to
be
given
into
the
anterior half
of
the neck.
Oestrus
synchronisation:
1
mL
(1
00(lg
Gonadorelin)
per
dose
by
intramuscular
injection.
(See
enclosed
leaflet).
WITHHOLDING PERIODS: NIL.
TRADE ADVICE
EXPORT SLAUGHTE INTERVAL (ESI):
This
product
does
not
have
an
ESI
established.
For
advice
on
the
ESI,
contact the
manufactuer
on
(02)
9667
4411
before using this product
PARNELL AUSTRALIA PTY LTD
4/476 Gardeners
Road,
Alexandria NSW
2015
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
OVSYNCH 1
injection
ACTIVE CONSTITUENT:
GONADORELIN (as acetate) 100 (lg/mL
For use
in
oestrus s

Summary of Product characteristics

PAGE 1 OF 2
MATERIAL SAFETY DATA SHEET:
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
PRODUCT NAME : Ovsynch 1, Ovsynch 3
OTHER NAMES :_ _
Gonadorelin, GnRH, Gonadorelin Injection, Fertagyl®
RECOMMENDED
USE:
FOR
ANIMAL
TREATMENT
ONLY.
Use
in
oestrus
synchronization
programs
in
combination with PGF
2α
.
MANUFACTURER COMPANY DETAILS:
LICENSEE (NEW ZEALAND) DETAILS:
Parnell Manufacturing Pty Ltd
Parnell NZ Co
ADDRESS
ADDRESS
Unit 4, Century Estate
PO Box 73160
476 Gardeners Road
Auckland International Airport
Alexandria, NSW 2015
Manukau 2150
Australia
New Zealand
TELEPHONE NUMBER
TELEPHONE NUMBER
61 (0)2-9667 4411
0800 446 282 (Toll free within NZ)
EMERGENCY TELEPHONE NUMBER
EMERGENCY TELEPHONE NUMBER
61 (0)2-9667 4411 (Business Hours)
0800 446 282 (Business Hours)
FACSIMILE NUMBER
FACSIMILE NUMBER
61 (0)2-9667 4139
0800 727 533 (Toll free within NZ)
2. HAZARDS IDENTIFICATION
Hazardous substance according to criteria of Worksafe Australia.
3. COMPOSITION/INFORMATION ON INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Gonadorelin (as acetate)
52699-48-6
0.01% w/v
Preservative
0.5-1.0% w/v
Buffers
1.0-1.5% w/v
Ionic adjuster
0.5-1.0% w/v
Water
7732-18-5
to 100%
4. FIRST AID MEASURES
Wash off any product_ _contacting skin immediately using soap and
water. Seek medical assistance if required.
SWALLOWED: Rinse mouth and drink plenty of water. Keep at rest. Seek
medical advice.
EYE: If in eyes, hold eyes open, flood with water or physiological
saline for at least 15 minutes. Seek medical
assistance if required.
SKIN: If skin contact occurs remove contaminated clothing and wash
skin thoroughly with mild soap and water.
Seek medical assistance if required.
INHALED: Seek medical assistance if required.
FIRST AID FACILITIES: No specific first aid facilities required.
ADVICE TO DOCTOR: Treat symptomatically as required.
5. FIRE-FIGHTING MEASURES
This material is not considered a fire hazard. Use standard fire
fighting techniques to extinguish fires involving
this material. Use water spray, d