FOLLIGON SERUM GONADOTROPHIN 5000 I.U.

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

GONADOTROPHIN-SERUM

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

gonadotrophin-serum(5000IU/vial)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

GONADOTROPHIN-SERUM HORMONE-GONADOTROPHIN Active 200.0 IU/ml

Units in package:

#1x5000IU; #Bottle; #diluent; #with 25mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: NIL; Host/pest details: BULL: [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; CATTLE: [HORMONAL MANIPULATION, STIMULATE OVULATION]; COW: [ANOESTRUS, HORMONAL MANIPULATION, STIMULATE OVULATION]; DOG: [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; DOG - FEMALE (BITCH): [ANOESTRUS, HORMONAL MANIPULATION]; GOAT BUCK (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; GOAT DOE (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; PIG BOAR (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; PIG SOW (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; SHEEP EWE (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; SHEEP RAM (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; Poison schedule: 4; Withholding period: ; Host/pest details: BULL: [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; CATTLE: [HORMONAL MANIPULATION, STIMULATE OVULATION]; COW: [ANOESTRUS, HORMONAL MANIPULATION, STIMULATE OVULATION]; DOG: [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; DOG - FEMALE (BITCH): [ANOESTRUS, HORMONAL MANIPULATION]; GOAT BUCK (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; GOAT DOE (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; PIG BOAR (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; PIG SOW (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; SHEEP EWE (FEMALE): [ANOESTRUS, HORMONAL MANIPULATION]; SHEEP RAM (MALE): [HORMONAL MANIPULATION, IMPAIRED SPERMATOGENESIS]; For hormonal manipulation of anoestrus and impaired spermatogenesis in cattle, sheep, goats, pigs and dogs. For use in induction of superovulation in cattle.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FOLLIGON SERUM GONADOTROPHIN 5000
IU-
37206
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
00
New Product (include all applicable RLPs) OR
[J
Variation
{highlight instructions that are
being
varied).
Approval
no.
of
label
being
varied:
[APVMA
NO.
37206/SU/0209]
Signal
heading:
PRESCRIPTION
ANIMAL
REMEDY
+
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Product
name:
FOLLIGON®
RLP
Approved
SERUM
GONADOTROPHIN
5000
IU
Active
ACTIVE
CONSTITUENT:
SERUM
GONADOTROPHIN
200
IU/ML
when
CONSTITUENT/S:
reconstituted
Statement
of
For hormonal manipulation
of
anoestrus
and
impaired spermatogenesis in Cattle,
CLAIMS:
Sheep,
Goats,
Pigs
and
Dogs.
For
use
in induction
of
superovulation
in
Cattle.
MODE
OF
ACTION
FOLLIGON®
is
a complex glycoprotein obtained
from
the
serum
of
pregnant mares.
Because
of
its relative instability in solution
it
is
marketed in freeze-dried
form.
FOLLIGON®
has
a stimulating influence
on
the gonads
of
both
the
female and male
animal. Thus
FOLLIGON®
stimulates the development
of
the ovarian follicle in
the
female
and
has
spermatogenetic activity in the male
by
its effect on
the
seminiferous
tubules.
Net
contents:
I
X
5000
IU
BOTTLE
WITH
25
ML
DILUENT.
Directions
for
Use
READ
THE
ENCLOSED
LEAFLET
BEFORE
USING
THIS
PRODUCT.
Heading:
DIRECTIONS
FOR
USE
Restraints:
Not applicable
CONTRAINDICATIONS:
Not
applicable.
PRECAUTIONS:
In
rare
cases,
as
with
all
protein preparations, anaphylactoid incidents may
occur
shortly after injection. Adrenaline injection
(I:
I 000) given IV
or
IM when symptoms
appear
is
the
standard treatment. The administration
of
a corticosteroid may also
be
indicated.
Side
Effects:
Not
applicable.
Page 1
of3
FOLLIGON SERUM GONADOTROPHIN 5000
IU-
37206
Dosage
&
DIRECTIONS
FOR
USE
ADMINISTRATION:
To
avoid microbial contamination, unused
portions
of
the
product
must be discarded
within
24 hours after reconstitution
or
first
broaching
of
the vial.
Withdraw
5
mL
of
diluent and reconstitute
FOLLIGON®
vial.
Transfer reconstituted material
to
r

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Summary of Product characteristics

PRODUCT NAME: FOLLIGON® SERUM GONADOTROPHIN
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Pregnant mare serum gonadotrophin freeze dried in 1000, 5000 or 20000
iu sterile
injection vials plus vials of sterile diluent.
TRADE NAME:
FOLLIGON
® SERUM GONADOTROPHIN
OTHER NAMES:
This MSDS is intended for packs with 1000, 20,000 and 50,000IU
gonadotrophin content.
PRODUCT CODE:
21137, 21139, 21141
RECOMMENDED USE:
Source of follicle stimulating hormone activity (SH) and luteinizing
hormone activity
(ICSH) by subcutaneous or intramuscular injection for use in horses,
cattle, sheep, goats,
pigs, dogs and cats.
APVMA NO:
37206, 37208 & 37209
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:
S45, S24/25. In case of accident or if you feel unwell, contact a
doctor or Poisons Information Centre
immediately (show the label where possible). Avoid contact with skin
and eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Freeze dried solid powder or plug, and vial of water for
reconstituting.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
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

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