DURATESTON INJECTION OF MIXED TESTOSTERONE ESTERS

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:

TESTOSTERONE DECANOATE; TESTOSTERONE ISOCAPROATE; TESTOSTERONE PROPIONATE; TESTOSTERONE PHENYLPROPIONATE

Available from:

Intervet Australia Pty Limited

INN (International Name):

testosterone propionate(6mg/mL) + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TESTOSTERONE DECANOATE STEROID-ANABOLIC Active 20.0 mg/ml; TESTOSTERONE ISOCAPROATE STEROID-ANABOLIC Active 12.0 mg/ml; TESTOSTERONE PROPIONATE STEROID-ANABOLIC Active 6.0 mg/ml; TESTOSTERONE PHENYLPROPIONATE STEROID-ANABOLIC Active 12.0 mg/ml

Units in package:

10 x 5mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat (Horses): Not to be used in horses intended for human consumption.; Host/pest details: CAT: [ANABOLIC STEROID]; DOG: [ANABOLIC STEROID]; HORSE: [ANABOLIC STEROID]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANABOLIC STEROID]; DOG: [ANABOLIC STEROID]; HORSE: [ANABOLIC STEROID]; Indicated in cases of ageing and debility, deficient sex drive, cryptorchidism and hypogonadism in all species. For the treatment of alopecia of hormonal origin, pseudo pregnancy and oestrogen dependent mammary tumors in dogs and cats.Should NOT be administered to animals suffering from prostatic carcinoma or prostatic hyperplasia. DO NOT USE in food producing species of animals.

Authorization status:

Stopped

Authorization date:

2021-07-01

Patient Information leaflet

090382F
961 / 0005
READ LEAFLET
BEFORE USING
THIS PRODUCT.
RESTRAINT: DO
NOT USE in food
producing species
of animal.
Store below 25°C
(Air conditioning).
Protect from light.
APVMA
37230/5M/0504
DURATESTON
®
Batch No.:
Expiry Date:
090382F 0005.880.2051
Each mL contains 50 mg
of testosterone as:
PROPIONATE
6 mg
PHENYLPROPIONATE 12 mg
ISOCAPROATE
12 mg
DECANOATE
20 mg
5 mL
PRESCRIPTION ANIMAL
REMEDY
961/0005/880/090382F 12-07-2004 15:29 Pagina 1
Info
PEST

Verified
10 x 5 mL
049354D
166/5093
Pms 328
INTERVET AUSTRALIA PTY LIMITED
91 – 105 Harpin Street
BENDIGO EAST VIC 3550
Phone: (03) 5440 9888
INJECTION OF MIXED TESTOSTERONE ESTERS.
ACTIVE CONSTITUENTS:
Each mL contains 50 mg of testosterone as:
TESTOSTERONE PROPIONATE
6 mg
TESTOSTERONE PHENYLPROPIONATE
12 mg
TESTOSTERONE ISOCAPROATE
12 mg
TESTOSTERONE DECANOATE
20 mg
Mixed testosterone esters for long term androgen therapy in Horses,
Dogs and Cats.
DURATESTON
®
E-42
049354D 5093.880.2054
Batch No.:
Expiry Date:
DISPOSAL:
Dispose of empty container by wrapping
with paper and putting in garbage.
STORAGE:
Store below 25°C (Air conditioning).
Protect from light.
APVMA Approval No.: 37230/5M/0504
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINT:
DO NOT USE in food producing species of animal.
CONTRAINDICATIONS:
Androgens should not be administered to animals suffering from
prostatic carcinoma or prostatic hyperplasia.
DOSAGE AND ADMINISTRATION:
Use the contents of the vial within 24 hours of initial broaching.
Discard any unused portion.
Give by intramuscular or subcutaneous injection.
Dog and Cat
50 -150 mg (1-3 mL) monthly.
Horse
500 mg (10 mL) monthly.
If used in performance animals, the regulations of the relevant
authorities regarding medication should be observed.
WITHHOLDING PERIOD
MEAT (HORSES): NOT TO BE USED in horses intended for human
consumption.
FIRST AID:_ If poisoning occurs, contact a doctor or Poisons
Information Centre. _
_Ph

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Summary of Product characteristics

PRODUCT NAME: DURATESTON® INJECTION OF MIXED TESTOSTERONE
ESTERS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
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:
Sterile oily solution of Testosterone esters for injection 50mg/mL
TRADE NAME:
DURATESTON
® INJECTION OF MIXED TESTOSTERONE ESTERS
PRODUCT CODE:
21127
RECOMMENDED USE:
Animal vaccine for use as described on the product label.
APVMA NO:
37230
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:
S25, S45. Avoid contact with eyes. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear, light yellow liquid.
ODOUR:
Characteristic odour of peanuts or overheated fat
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
Testosterone is almost non-toxic. Hypersensitivity to Arachis (peanut)
Oil: A pre-existing hyper-sensitivity to arachis oil is
possible due to its origin in peanuts. This may result in reactions
such as rashes, urticaria or even skin ulceration at the
site of accidental self-injection. Anyone with an allergy to peanuts
should avoid all contact with this product.
INHALATION:
SHORT TERM EXPOSURE:
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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