RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE

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:

BUSERELIN ACETATE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

buserelin(0.004mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

BUSERELIN ACETATE HORMONE-GONADOTROPHIN Active 0.0040 mg/ml

Units in package:

10mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: 0 days TRADE ADVICE: EXPORT SLAU GHTER INTERVAL: 0 days; Host/pest details: CATTLE: [FERTILITY PROBLEMS]; COW: [ANOESTRUS, DELAYED OVULATION, FERTILITY PROBLEMS, IMPROVE PREGNANCY RATE]; FINFISH: [EGG BINDING]; HORSE MARE (FEMALE): [ANOESTRUS, FERTILITY PROBLEMS, FOLLICLE STIMULATING HORMONE, INDUCTION OF OVULATION]; PIG GILT (YOUNG BREEDING FEMALE): [INDUCTION OF OVULATION]; RABBIT: [IMPROVE PREGNANCY RATE, INDUCTION OF OVULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [FERTILITY PROBLEMS]; COW: [ANOESTRUS, DELAYED OVULATION, FERTILITY PROBLEMS, IMPROVE PREGNANCY RATE]; FINFISH: [EGG BINDING]; HORSE MARE (FEMALE): [ANOESTRUS, FERTILITY PROBLEMS, FOLLICLE STIMULATING HORMONE, INDUCTION OF OVULATION]; PIG GILT (YOUNG BREEDING FEMALE): [INDUCTION OF OVULATION]; RABBIT: [IMPROVE PREGNANCY RATE, INDUCTION OF OVULATION]; For the treatment of infertility of ovarian origin and improvement of pregnancy rate in cows. For the treatment of anoestrus and to induce ovulation of a mature follicle in mares. For induction of ovulation in gilts & rabbits, Finfish - see label.see leaflet for details

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

•'
RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE 36019
V3-
29 Sept 2014
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
D
New Product (include all applicable RLPs) OR
ll'1l
Variation
(highlight instructions that are
being
varied).
Approval
no.
of
label
being
varied:
[APVMA NO. 36019/ATS NO. 55480]
Signal
heading:
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Product
name:
RECEPTAL® SYNTHETIC GONADOTROPHIN RELEASING
HORMONE
Active
ACTIVE
CONSTITUENT:
BUSERELIN
0.004
mg
per mL
CONSTITUENT/S:
Statement
of
For the treatment
of
infertility
of
ovarian origin
and
improvement
of
pregnancy rates
CLAIMS:
in
cows. For
the
treatment
of
anoestrus
and
to
induce ovulation
of
a mature follicle in
mares. For induction
of
ovulation in gilts
and
rabbits.
PRESENTATION
A ready-to-use colourless, aqueous injection solution
for
parenteral administration.
Buserelin
is
equivalent
to
the natural LH/FSH releasing hormone produced in the
hypothalamus.
It
causes
simultaneous release
of
lutein ising hormone (LH) and follicle
stimulating hormone
(FSH)
from the pituitary.
INDICATIONS
-
For
the
treatment
of
infertility
of
ovarian origin
and
improvement
of
pregnancy
+
RATE
IN
COWS.
-
For
the
synchronisation
of
oestrus in dairy cows
and
for
reducing
the
calving
to
conception interval in these cows when
used
in conjunction
with
PGF
2a
analogue
with
luteolytic activity
as
part
of
a
10
day fixed time insemination
RLP
regime.
Approved
-
For the treatment
of
anoestrus
in
mares.
-
To
induce ovulation
of
a mature follicle
and
thereby
to
synchronise ovulation
more closely
with
mating in mares.
-
For induction
of
ovulation after oestrus synchronization in
order
to
optimize
conception rate when
used
as
part
of
a single fixed time insemination program in
gilts.
-
To
induce ovulation
in
rabbits
-
For facilitate stripping
and
reduce mortality due
to
egg
binding
in
Finfish.
Net
contents:
10
ML, 50
ML
DIRECTIONS
FOR
USE
DIRECTIONS
FOR
USE:
Heading:
READ
THE
ENCLOSED
LEAFLET
BEF

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Summary of Product characteristics

PRODUCT NAME: RECEPTAL® SYNTHETIC GONADOTROPHIN RELEASING
HORMONE
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:
Active ingredient is a hormone.
TRADE NAME:
RECEPTAL
® SYNTHETIC GONADOTROPHIN RELEASING HORMONE
PRODUCT CODE:
701599
RECOMMENDED USE:
For the treatment of infertility of ovarian origin and improvement of
pregnancy rate in
cows. For the treatment of anoestrus and to induce ovulation of a
mature follicle in mares.
APVMA NO:
36019
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:
S20, S45, S24/25. When using, do not eat or drink. 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:
Clear liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, but is unlikely
to cause any

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