FOLLTROPIN-V FOLLICLE STIMULATING HORMONE FOR INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

FSH-PORCINE

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

FSH - domestic(400mg/vial)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

FSH-PORCINE HORMONE-FOLLICLE STIMULATING Active 400.0 mg/20mL

Units in package:

20mL

Class:

VM - Veterinary Medicine

Therapeutic group:

COW | HEIFER (YOUNG FEMALE CATTLE) | BOVINE | COW YOUNG | FEMALE CATTLE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

INDUCE SUPEROVULATION

Product summary:

Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: 0 DAYS. (ESI): This product does not have an ESI establ ished. For advice on the ESI contact Bio niche on 1800 032 355.; Host/pest details: COW: [INDUCE SUPEROVULATION]; HEIFER (YOUNG FEMALE CATTLE): [INDUCE SUPEROVULATION]; Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: 0 DAYS. TRADE ADVI CE: EXPORT SLAUGHTER INTERVAL (ESI): T his product does not have an ESI establ ished. For advice on the ESI contact Bioniche on 1800 032 355.; Host/pest details: COW: [INDUCE SUPEROVULATION]; HEIFER (YOUNG FEMALE CATTLE): [INDUCE SUPEROVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: COW: [INDUCE SUPEROVULATION]; HEIFER (YOUNG FEMALE CATTLE): [INDUCE SUPEROVULATION]; For induction of superovulation in cattle.Not for administration to pigs

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Folltropin-V Follicle Stimulating Hormone for Injection
Nov 2017
38750/54224 box, vials and leaflet
Version 1 page 1 of 5
_Active constituent bottle label main panel _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
FOLLTROPIN
®
-V
Follicle Stimulating Hormone for Injection
ACTIVE CONSTITUENT:
FOLLICLE STIMULATING HORMONE………….400 mg*
(equivalent to 20 mg*/mL when reconstituted according to directions)
Vetoquinol Australia Pty Ltd
_Active constituent bottle label ancillary panel 1 _
Follicle stimulating hormone for induction of superovulation in cattle
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
NOT FOR ADMINISTRATION TO PIGS.
FOR INTRAMUSCULAR USE.
Reconstitute Folltropin
®
-V with Folltropin
®
-V Diluent (Bacteriostatic Sodium Chloride
Injection USP)
DOSAGE AND ADMINISTRATION
Store reconstituted Folltropin
®
-V at between 2°C and 8°C (Refrigerate. Do not
freeze). Use the contents within 5 days of reconstitution. Discard the
unused portion.
Cattle: 2.5 mL (50 mg*), twice daily, for four days.
WITHHOLDING PERIOD: 0 DAYS.
_Active constituent bottle label ancillary panel 2 _
Store below 25°C (Air Conditioning). Protect from light.
Dispose of empty container by wrapping with paper and putting in
garbage.
APVMA Approval No. 38750/54224
BATCH:
EXP.:
APPROVED NON-RLP
AMENDMENT MADE
Folltropin-V Follicle Stimulating Hormone for Injection
Nov 2017
38750/54224 box, vials and leaflet
Version 1 page 2 of 5
_Sterile Diluent bottle label main panel _
FOR ANIMAL TREATMENT ONLY
FOLLTROPIN
®
-V
Sterile Diluent
(Bacteriostatic Sodium Chloride Injection USP)
Reconstitute Folltropin
®
-V with Folltropin
®
-V Diluent
20 mL
Distributed by: Vetoquinol Australia Pty Ltd
ACN 006 949 480
Unit 302/2, 6-12 Boronia Road, Da Vinci Business Park, Brisbane
Airport, Qld 4008,
Australia
Telephone: [phone]
_Sterile Diluent bottle label ancillary panel 1 _
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
NOT FOR ADMINISTRATION TO PIGS.
FOR

Summary of Product characteristics

PRODUCT NAME: FOLLTROPIN-V FOLLICLE STIMULATING HORMONE FOR INJECTION
PAGE: 1 OF 5
THIS REVISION ISSUED: OCTOBER, 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:
Follicle stimulating hormone is a hormone.
TRADE NAME:
FOLLTROPIN-V FOLLICLE STIMULATING HORMONE FOR INJECTION
APVMA CODE:
38750
PRODUCT USE:
Follicle stimulating hormone for induction of superovulation in
cattle.
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. Do not breathe dust.
SUSMP CLASSIFICATION:
S4
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.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
P403+P235: Store in a well-ventilated place. Keep cool.
DISPOSAL
P501: Dispose of contents and containers as specified on the
registered lab

Safety Data Sheet

INJECTABLE SOLUTION
Distributed by: Vetoquinol Australia Pty Ltd
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park, Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
ACTIVE CONSTITUENT: FOLLICLE STIMULATING HORMONE .... 400 mg*
(equivalent to 20 mg*/mL when reconstituted according to directions)
For Induction of Superovulation in Cattle
Net Contents:
One FSH vial 400 mg*
One diluent vial 20 mL
DIRECTIONS FOR USE:
Not for administration to pigs. For intramuscular use. Reconstitute
Folltropin® -V
with Folltropin® -V Diluent (Bacteriostatic Sodium Chloride Injection
USP).
Store reconstituted Folltropin®-V at between 2°C and 8°C
(Refrigerate. Do not freeze).
Use the contents within 5 days of reconstitution. Discard the unused
portion.
WITHHOLDING PERIOD: 0 DAYS
TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not
have an
ESI established. For advice on the ESI, contact Vetoquinol on 1800 032
355.
Store below 25 C (Air Conditioning).
Protect
from
light.
Dispose
of
empty
container by wrapping with paper and
putting in garbage.
Manufactured by:
Vetoquinol N-A Inc.
Belleville, Ontario, Canada
APVMA Approval No.
38750/54224
STORAGE, HANDLING & DISPOSAL:
Follicle Stimulating Hormone for Injection
INJECTABLE SOLUTION
_FOLLTROPIN -V _
®
_FOLLTROPIN -V_
®
Follicle Stimulating Hormone for Injection
PANTONE 7740C
PANTONE 375C
PANTONE 631C
PANTONE 485C
BLACK
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131126.
*National Institutes of Health (U.S.A.) reference standard NIH-FSH-P1.
FIRST AID:
100529 A
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
BATCH:
:
P
X
E
ACTIVE CONSTITUENT:
FOLLICLE STIMULATING HORMONE
400 MG* (EQUIVALENT TO 20 MG*/ML
WHEN RECONSTITUTED ACCORDING
TO DIRECTIONS)
_FOLLTROPIN -V_
Follicle Stimulating Hormone
for Injection
®
Follicle stimulating hormone for induction of
superovulation in cattle.
READ THE ENCLOSED LEAFLET BEFORE U