Suprelorin 9.4 mg

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DESLORELIN AS DESLORELIN ACETATE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

deslorelin as acetate(9.4mg/Imp)

Pharmaceutical form:

PARENTERAL IMPLANT, DEVICE

Composition:

DESLORELIN AS DESLORELIN ACETATE UNGROUPED Active 9.4 mg/Im

Units in package:

1 implant; 2 implants

Class:

VM - Veterinary Medicine

Manufactured by:

VIRBAC

Therapeutic group:

DOG - MALE

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

REDUCING TESTOSTERONE PRODUCTION

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - MALE: [REDUCING TESTOSTERONE PRODUCTION]; FERRETS: [REDUCING TESTOSTERONE PRODUCTION]; Implantable slow release gonadotropin releasing hormone (GnRH) analogue that can suppress fertility in male dogs & ferrets by reducing testosterone production to a level where sperm production and the ability to ejaculate generally disappears. Aids in...See PRECAUTIONS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Virbac (Australia)
Ptv
Limited
PaQe
1
Product
Name:
SUPRELORIN 12 (9.4mg)
APVMANo.:
60359
Text Labels:
Carton. Pouch. Leaflet
Country:
Australia
Pack Sizes:
1,
2 implants
VERSION DATE:
07-05-14
Text above
the
header line and in italics between parallel lines does not
appear
on
the label.
I
CARTON-
Front Panel
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
SUPRELORIN
12®
of
10
EACH IMPLANT CONTAINS 9.4 MG DESLORELIN (AS DESLORELIN ACETATE)
Implantable slow release Gonadotropin Releasing Hormone (GnRH)
analogue that
can suppress fertility
in
male dogs and ferrets by reducing testosterone production to
a level where sperm production and the ability to ejaculate generally
disappears.
Aids
in
the management
of
hyperadrenocorticism
in
neutered ferrets.
12
MONTHS SUPPRESSION IN DOGS
The
leaflet
should
be
consulted
for
further information
on
treatment of ferrets.
CONTENTS:
One (1) implant preloaded
in
an implanter
Two (2) implants preloaded
in
implanters and individually packaged

RLP
Approved
Virbac (Australia) Pty Limited
PaQe
2
of
Product
Name:
SUPRELORIN
12
(9.4mg)
APVMANo.:
60359
Text Labels:
Carton. Pouch. Leaflet
Country:
Australia
Pack Sizes:
1,
2 implants
VERSION DATE:
07-05-14
Text above the header line and in italics between parallel lines does
not appear
on
the label.
I
CARTON-
Back Panel
DIRECTIONS FOR USE: READ THE ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT. Do
not use if the foil pouch is broken. Administer one implant only.
One implant should
be
placed subcutaneously between the shoulder blades of the
dog or ferret.
FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre.
Phone Australia 131126.
ADDITIONAL USER SAFETY INFORMATION:
Avoid contact with skin.
DISPOSAL:
Do not attempt
to
re-use the implanter; dispose of the implanter
in
a similar manner
to a used syringe.
Note that the actuator can
be
re-used.
STORAGE:
Store at
2oC
to
soc
(Refrigerate, do not freeze)
APVMA Number: 60359160907
Virbac
I
Peptech I

Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
SUPRELORIN12.DOC
REVISION A
SAFETY DATA SHEET
Product Name:
Suprelorin 12
PAGE: 1 OF 7
DATE OF ISSUE
16 DECEMBER,
2013
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
[phone] or 1800 242 100
FAX:
[phone]
EMERGENCY PHONE
As above during business hours.
After Hours - Poisons Information Centre: 13 1126
from anywhere in Australia, (0800 764 766 in New Zealand)
CHEMICAL NATURE:
Slow release gonadotropin releasing hormone (GnRH) analogue in an
implant.
TRADE NAME:
SUPRELORIN 12
APVMA CODE:
60359
PRODUCT USE:
Implantable slow release gonadotropin releasing hormone (GnRH)
analogue that can
suppress fertility in male dogs. FOR VETERINARY USE ONLY.
CREATION DATE:
DECEMBER, 2013
THIS VERSION ISSUED:
DECEMBER, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Xn, Harmful. Hazardous according to the
criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R21, R60. Harmful in contact with skin. May impair fertility.
SAFETY PHRASES:
S28, S45, S24/25. After contact with skin, wash immediately with
plenty of soap and water. In
case of accident or if you feel unwell, contact a doctor or Poisons
Information Centre immediately (show this SDS
where possible). Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: DANGER
HAZARD STATEMENT:
H360: May damage fertility or the unborn child.
PREVENTION
P102: Keep out of reach of children.
P201: Obtain special instructions before use.
P202: Do not hand