Suprelorin 4.7 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(4.7mg/Im)

Pharmaceutical form:

PARENTERAL IMPLANT, DEVICE

Composition:

DESLORELIN AS DESLORELIN ACETATE UNGROUPED Active 4.7 mg/Im

Units in package:

Five (5) implants preloaded in implanters; Two (2) implants preloaded in implanters

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]; Implantable slow release gonadotropin releasing hormone (GnRH) analogue that can suppress fertility in male dogs by reducing testosterone production to a level where sperm production and the ability to ejaculate generally disappears.Use with caution in breeding dogs. See PRECAUTIONS, ADVERSE REACTIONS sections on leaflet.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Suprelorin 4.7 mg
Label Name:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Signal Headings:
Each implant contains:
4.7 mg Deslorelin (as deslorelin acetate)
Constituent
Statements:
[REDUCED CLAIM - CARTON]
Implantable slow release Gonadotropin Releasing Hormone (GnRH)
analogue that can
suppress fertility in male dogs by reducing testosterone production to
a level where sperm
production and the ability to ejaculate generally disappears.
6 MONTHS SUPPRESSION IN DOGS.
[FULL INDICATIONS - LEAFLET]
Suprelorin 4.7 mg is indicated for the temporary suppression of
fertility in normal entire
dogs by reduction of testosterone levels. It can be used as an
alternative to surgery and
as an aid in the control of testosterone related unacceptable
behaviour (in combination
with the appropriate behavioural therapy) and androgen-induced disease
such as benign
prostatic hyperplasia.
Claims:
Two (2) implants preloaded in implanters
Five (5) implants preloaded in implanters
Net Contents:
Directions for Use:
Restraints:
Contraindications:
Precautions:
Use with caution in breeding dogs. In some case there may be a
significant delay in return
of testosterone production beyond six months and therefore a
corresponding delay in return
to onset of breeding capacity after a single dose of Suprelorin 4.7
mg. The effect of repeat
Product Name:
APVMA Approval No.
SUPRELORIN 4.7 mg
56107 / 134224 RLP APPROVED
Systemic adverse reactions have not been observed in dogs (n=387) with
the use of
Suprelorin 4.7 mg (deslorelin) at the recommended dosage.
Approximately 1% of treated
animals, those given a 10 times dose, showed some soreness and
swelling at the
implantation site which resolved over one or two weeks. Undesirable
histology has not
been found at the site of implantation.
Side Effects:
Withholding Periods:
Trade Advice:
Safety Directions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 13 11
26.
First Aid Instructions:
Dosage and
Administration:
Do not use if the foil

Summary of Product characteristics

 
Peptech Animal Health 

MSDS – Suprelorin 4.7 mg 01/08 

Page 1 of 9 

MATERIAL SAFETY DATA SHEET 

1.  STATEMENT OF HAZARDOUS NATURE PRODUCT AND
COMPANY IDENTIFICATION 

Product Name 
Suprelorin 4.7 mg 

(Veterinary implant containing 
deslorelin 4.7 mg) 
Emergency Contacts:  
Phone:  [phone] (Australia) 
Fax:      [phone] (Australia) 
Australian Poisons 
Schedule (SUSDP) 

Hazardous Classification 
Schedule 4 

Hazardous 

Supplier 
Peptech Animal Health 
19-25 Khartoum Road 
Macquarie Park 2113 
NSW 
Australia 

Email: 
[e-mail]

Date of Issue 
January 2008 

Revision Number 
5 

2.  COMPOSITION/INFORMATION ON INGREDIENTS 

Ingredient name 
Deslorelin Acetate 
IUPAC Name 
5-oxoPro-His-Trp-Ser-Tyr-DTrp-Leu-Arg-
ProNHCH
2
CH
3

Amino Acid Sequence 
pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro ethylamide 
CAS Number 
57773-65-6 
UN Number, Dangerous  
Goods Class  
Not allocated 
Hazchem Code 
Not allocated 
Other ingredients 
Non hazardous 
Presentation 
The implant is contained in a preloaded syringe with an 
attached needle (implanter), packaged inside a foil 
laminate pouch.  Five or two pouches and contents are 
packed, together with information leaflet, in a carton. 

3.  HAZARDS IDENTIFICATION 

Approved Criteria  
Classification 
Hazardous Material 

Australian Poisons (SUSDP) Schedule 
Schedule 4 

EMERGENCY OVERVIEW 

Physical Description 
The implant is a solid, opaque, white to pale yellow 
cylinder 2.3 mm x (about) 12.5 mm length. 

Major Health Hazards 
May impair fertility 

Peptech Animal Health 

MSDS – Suprelorin 4.7 mg 01/08 

Page 2 of 9 

POTENTIAL HEALTH EFFECTS 

The active ingredient, deslorelin,
is a gonadotropin releasing-hormone (GnRH) agonist and has
actions 
similar to endogenous GnRH which is the ke