P.G. 600 INJECTION OF SERUM GONADOTROPHIN (400 I.U.) AND CHORIONIC GONADOTROPHIN (200 I.U.)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

GONADOTROPHIN-CHORIONIC; GONADOTROPHIN-SERUM

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

gonadotrophin-serum(400IU/vial)+gonadotrophin-chorionic(200IU/vial)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

GONADOTROPHIN-CHORIONIC HORMONE-GONADOTROPHIN Active 200.0 IU/vial; GONADOTROPHIN-SERUM HORMONE-GONADOTROPHIN Active 400.0 IU/vial

Units in package:

!5 x Vials; !5mL Vials; !600 I.U.; #5 x Vials; #5mL Vials; #diluent

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

PIG SOW (FEMALE) | FEMALE PIG

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

SYNCHRONISATION OF OESTRUS & OVULATION

Product summary:

Poison schedule: 4; Withholding period: WHP: Nil.; Host/pest details: PIG SOW (FEMALE): [SYNCHRONISATION OF OESTRUS & OVULATION]; For oestrus induction in pigs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

P.G.
600®
INJECTION
OF
SERUM
GONADOTROPHIN
(400
I.U.)
AND
CHORIONIC
GONADOTROPHIN
(200
I.U.)-
37234-
V2
19Sept2014
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
[]
New
Product (include
all
applicable
RLPs)
OR
lRI
Variation
(highlight instructions that
are
being
varied).
Approval
no.
of
label
being
varied:
[APVMA NO. 37234/0707 (PRODUCT); 37234/1204 DILUENT)]
Signal heading
(Product):
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Signal heading
FOR ANIMAL TREATMENT ONLY
(Diluent):
Product name:
P.G. 600® INJECTION OF SERUM GONADOTROPHIN (400 I.U.) AND
CHORIONIC GONADOTROPHIN (200 I.U.)
Diluent name:
Active
constituent/s
(Product):
Active
constituent
(Diluent):
Statement
of
claims - Short
version (5mL
vial label,
5x5mL carton
single dose
vials with
diluent)
Statement of
claims-
Long
version (leaflet)
Statement of
claims-
5 mL
Diluent label:
Net contents:
Carton:
Vial:
Diluent:
P.G. 600® DILUENT
Each vial
of
freeze-dried material contains:
Serum Gonadotrophin 400
I.U.
Chorionic Gonadotrophin 200 I.U.
PHOSPHATE BUFFERED SALINE
For oestrus induction
in
pigs.
I
Gilt: Administration
of
a single dose
of
P.G. 600® to gilts over the age of 5
months will normally result
in
a fertile oestrus within 5 days.
Sows post-weaning: To promote early post-partum oestrus (particularly
where
early weaning is practised) it is recommended that a single injection
of
P.G.
600® is given within 48 hours of weaning.
Barren sows: Cases of suboestrus and anoestrus due to hormonal
imbalance
(often associated with previous debility
or
stress) may respond favourably to a
single dose of P.G. 600®, exhibiting normal heat within 5 days
of
injection.
For reconstitution of P.G. 600® freeze-dried powder.
5 x 5 mL SINGLE DOSE VIALS WITH DILUENT
5
mL
5
mL
RLP
.a.ppruvoeu
Page 1
of3
P
G.
600®
INJECTION
OF
SERUM
GONADOTROPHIN
(400
I.U.)
AND
CHORIONIC
GONADOTROPHIN
(200
I.U.)-
37234-
V2
19Sept2014
Directions for
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Use Hea

Summary of Product characteristics

PRODUCT NAME: P.G. 600 INJECTION OF SERUM GONADOTROPHIN (400
I.U.) AND CHORIONIC GONADOTROPHIN (200 I.U.)
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
PMSG 400 iu HCG 200 iu in lyophilised form for sterile injection with
sterile solvent
presented in vials of 5 mL.
TRADE NAME:
P.G. 600 INJECTION OF SERUM GONADOTROPHIN (400 I.U.) AND CHORIONIC
GONADOTROPHIN (200 I.U.)
PRODUCT CODE:
21144
RECOMMENDED USE:
To promote fertile oestrus in non-pregnant gilts or sows for use by
injection only.
APVMA NO:
37234
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S45. Avoid contact with eyes. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White powder or lump in one vial; clear colourless solution - (saline
for
reconstituting the product) in the other.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
HCG given parenterally can profoundly influence human fertility so
care must be taken to avoid accidental self injection.
See section 11 for more complete details.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated w