PREGNECOL INJECTION SERUM GONADOTROPHIN 6000 I.U. PER VIAL

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

GONADOTROPHIN-SERUM

Available from:

Vetoquinol Australia Pty Ltd

INN (International Name):

gonadotrophin-serum(6000IU/vial)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

GONADOTROPHIN-SERUM HORMONE-GONADOTROPHIN Active 6000.0 IU/vial

Units in package:

10 x 6000; i.u. vials

Class:

VM - Veterinary Medicine

Therapeutic group:

CATTLE | DOG - FEMALE (BITCH) | GOAT | PIGS | SHEEP | BEEF | BILLY | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | B

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

ANOESTRUS | INCREASE OVULATION RATE | INDUCE SUPEROVULATION | INDUCING OESTRUS | LACTATION ANOESTRUS | OESTRUS INDUCTION | PROLONGED WEANING TO MATING

Product summary:

Poison schedule: 4; Withholding period: WHP: NIL; Host/pest details: CATTLE: [ANOESTRUS, INDUCE SUPEROVULATION]; DOG - FEMALE (BITCH): [ANOESTRUS]; GOAT: [INCREASE OVULATION RATE, INDUCE SUPEROVULATION, INDUCING OESTRUS]; PIGS: [ANOESTRUS, LACTATION ANOESTRUS]; SHEEP: [INCREASE OVULATION RATE, INDUCE SUPEROVULATION, INDUCING OESTRUS]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANOESTRUS, INDUCE SUPEROVULATION]; DOG - FEMALE (BITCH): [ANOESTRUS]; GOAT: [INCREASE OVULATION RATE, INDUCE SUPEROVULATION, INDUCING OESTRUS]; PIGS: [ANOESTRUS, LACTATION ANOESTRUS]; SHEEP: [INCREASE OVULATION RATE, INDUCE SUPEROVULATION, INDUCING OESTRUS]; For the hormonal manipulation of reproduction in sheep, goats, cattle, pigs and dogs.

Authorization status:

Stopped

Authorization date:

2021-07-01

Patient Information leaflet

Pregnecol Injection Serum Gonadotrophin 6000 i.u. per vial draft label
page 1 of 8
52009/0407 carton containing 10 vials
Version 1 – Nov 2017
_Vial label _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PREGNECOL
® INJECTION
SERUM GONADOTROPHIN
6000 I.U. PER VIAL
READ ENCLOSED LEAFLET BEFORE USING
WITHHOLDING PERIOD NIL
MANUFACTURED BY:
Vetoquinol Australia Pty Ltd
ABN 64 006 949 480
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park, Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
www.vetoquinol.com
STORE below 8°C (Refrigerate)
Protect from light.
Use immediately after reconstitution.
Discard unused material.
APVMA Approval No. 52009/(0407)
Batch:
Expiry:
®
Trademark
APPROVED NON-RLP
AMENDMENT MADE
Pregnecol Injection Serum Gonadotrophin 6000 i.u. per vial draft label
page 2 of 8
52009/0407 carton containing 10 vials
Version 1 – Nov 2017
_Carton label front panel _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PREGNECOL
® INJECTION
SERUM GONADOTROPHIN
6000 I.U. PER VIAL
FOR HORMONAL MANIPULATION OF REPRODUCTION IN SHEEP, GOATS, CATTLE,
PIGS AND
DOGS.
10 VIALS.
_Carton label ancillary panel 1 (carton back) _
PREGNECOL
® INJECTION
SERUM GONADOTROPHIN
6000 I.U. PER VIAL
READ ENCLOSED LEAFLET BEFORE USING
FOR INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
WITHHOLDING PERIOD NIL
FIRST AID: If poisoning occurs contact a doctor or Poisons Information
Centre. Phone
Australia 131126.
Use immediately after reconstitution.
Discard unused material.
STORE below 8°C (Refrigerate)
Protect from light.
Dispose of empty container by wrapping with paper and putting in
garbage.
6000 I.U. PER VIAL
10 VIALS.
DISTRIBUTED BY: _(contact details for exported product)_
Pregnecol Injection Serum Gonadotrophin 6000 i.u. per vial draft label
page 3 of 8
52009/0407 carton containing 10 vials
Version 1 – Nov 2017
_Carton label ancillary panel 2 (carton side 1) _
MANUFACTURED BY:
Vetoquinol Australia Pty Ltd
ABN 64 006 949 480
Unit 30

Summary of Product characteristics

PRODUCT NAME: PREGNECOL RANGE OF PRODUCTS
PAGE: 1 OF 5
THIS REVISION ISSUED: NOVEMBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: [phone]
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: [phone]
(BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: [phone]
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Serum Gonadotrophin is a complex glycoprotein obtained from the serum
of pregnant
mares.
TRADE NAME:
PREGNECOL RANGE OF PRODUCTS
APVMA CODES:
52009 (6000 I.U./vial), 52010 (1200 I.U./vial), 52011 (600 I.U./vial),
52122 (20000 I.U./vial), 52123 (1000 I.U./vial)
OTHER NAMES:
This SDS is intended for a range of Pregnecol products differing only
in the quantity
of material in the vials. To be reconstituted with suitable diluent.
PRODUCT USE:
Pregnecol is used as an aid to increase reproductive efficiency in
livestock.
CREATION DATE:
APRIL, 2007
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
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 Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S25. Do not breathe dust. Avoid contact with eyes.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P281: Use personal protective equipment as required.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P352: Wash with plenty of soap and water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting