RWR TESTOSTERONE SUSPENSION 100 INJECTION

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
TESTOSTERONE
Available from:
RWR VETERINARY PRODUCTS PTY LTD
INN (International Name):
testosterone(100mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
TESTOSTERONE STEROID-ANABOLIC Active 100.0 mg/ml
Units in package:
20mL
Class:
VM - Veterinary Medicine
Manufactured by:
RWR VETERINARY PRODS
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
ANABOLIC STEROID | ABORTION THREAT | ANDROGENIC PROPERTIES | BONE REPAIR | CATABOLIC COMPLICATIONS | CONVALESCENCE | ERYTHROPOIETIC ACTIVITY | GERIATRIC THERAPY | IMPROVE APPETITE | MALE SEXUAL CHARACTERISITICS | MUSCLE DEVELOPMENT | NON-VIRILISING ANABOLIC | PATHOPHYSIOLOGICAL PROCESS | PROTEIN AND MINERAL ANABOLIC | SKELETAL CONDITIONS | TISSUE BREAKDOWN | TISSUE REPAIR | VIRILISING ANABOLIC
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat withholding period: Not to be used in horses that will be slaughtere d for human consumption.; Host/pest details: DOG: [ANABOLIC STEROID]; HORSE: [ANABOLIC STEROID]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANABOLIC STEROID]; HORSE: [ANABOLIC STEROID]; Short acting androgenic steroid for horses and dogs.
Authorization status:
Registered
Authorization number:
52078
Authorization date:
2020-07-01

RWR

9 322387 001489

New Art 10/05/07

add spec text 25/08/08

Alt Art 02/12/08

w/t: 71117

date: 02/12/08

artist: Alfred

file name: TESTOSTERONE 20ml

size: 143x163mm

notes

date: 07/07/06

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colourtrue

phone 9550 9522

fax 9572 7994

pleas e

proof

carefull y,

errors

overlooked

become

client’s

l i a b i l i t y

100% black

Pantone 208

DIRECTIONS FOR USE:

Unused portion should be discarded

24 hours after first broaching vial.

Administer by intramuscular

injection only.

SHAKE WELL BEFORE USE

HORSES: 300 - 500mg

DOGS: 5 - 25mg

Repeat as indicated.

If used in performance animals,

the regulations of the relevant

authorities regarding medication

should be observed.

MEAT WITHHOLDING PERIOD:

NOT TO BE USED in horses

that will be slaughtered for

human consumption.

FIRST AID: If poisoning ocurs,

contact a doctor or Poisons

Information Centre. Phone

Australia 131 126.

RWR Veterinary Products Pty Ltd

Suite 601, 7 Help St.

Chatswood NSW 2067

Australia

DISPOSE of empty container

by wrapping with paper and

putting in garbage.

STORE below 25ºC

(Air Conditioning).

Protect from light.

APVMA No.: 52078/20mL/0508

Exp.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Short acting androgenic

steroid for horses and dogs.

20mL

SUSPENSION 100 INJECTION

ACTIVE CONSTITUENT:

TESTOSTERONE 100mg/mL

ACTIVE CONSTITUENT:

TESTOSTERONE 100mg/mL

TESTOSTERONE

RWR

SUSPENSION 100 INJECTION

TESTOSTERONE

RWR

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Short acting androgenic

steroid for horses and dogs.

20mL

SUSPENSION 100 INJECTION

TESTOSTERONE

FILE NAME: 52078_41702_10mL_primary_MPL_V01.pdf

DIMENSIONS: 143mm X 163mm

SCALE: 100% WHEN PRINTED TO A4

(96% IF FIT TO PAGE)

100% WHEN PRINTED TO A3

(137.5% IF FIT TO PAGE)

DATE: 25/08/08

APPROVED

LABEL

Info

pest

Verified

Exp.

20mL

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

SUSPENSION 100 INJECTION

ACTIVE CONSTITUENT:

TESTOSTERONE 100mg/mL

Short acting androgenic steroid for horses and dogs.

TESTOSTERONE

RWR

New art 11/05/07

add spec text 25/08/08

ALT ART 02/12/08

ALT ART 04/12/08

PMS 215

BLACK

w/t:

date: 04/12/08

artist: Alfred

file name: TESTOSTERONE

size: 32x80mm

notes

date

c l

i

e n t

u s e

labelcraft

phone 9550 0999

fax 9550 9734

please

proof

carefully,

errors

overlooked

become

client’s

l i a b i l i t y

FILE NAME: 52078_41702_10mL_immediate_MPL_V01.pdf

DIMENSIONS: 32mm X 80mm

SCALE: 100% WHEN PRINTED TO A4

(96% IF FIT TO PAGE)

100% WHEN PRINTED TO A3

(137.5% IF FIT TO PAGE)

DATE: 25/08/08

STORE below 25

(Air Conditioning).

Protect from light.

APVMA No: 52078/20mL/0508

READ CARTON BEFORE USE

MEAT WITHHOLDING PERIOD:

NOT TO BE USED in horses that will be

slaughtered for human consumption.

RWR Veterinary Products Pty Ltd

Suite 601, 7 Help St.

Chatswood NSW 2067

Page

of 4

Material Safety Data Sheet

RWR Testosterone Suspension 100 Injection

Statement of Hazardous Nature:

Hazardous according to criteria of Worksafe Australia.

COMPANY DETAILS

Company:

RWR PRODUCTS Pty Limited

Address:

SUITE 601, 7 Help St

Chatswood

NSW 2067

Telephone Number:

+61 (02) 49616422

Emergency Telephone Number:

+61 (02) 49616422 (Business Hours)

Poisons Information Service: 131126

Facsimile Number:

+61 (02) 49616433

IDENTIFICATION

Product Name:

RWR Testosterone Suspension 100 Injection

Other Names:

Testosterone, Testosterone Suspension, Test

Manufacturer’s Product Code:

UN Number:

None allocated

Dangerous Goods Class and Subsidiary Risk:

None allocated

Hazchem Code:

None allocated

Poisons Schedule Number:

Schedule 4

Use:

Short acting androgenic steroid for horses and dogs. For animal treatment only.

Page

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Material Safety Data Sheet

RWR Testosterone Suspension 100 Injection

Physical Description/Properties:

Appearance:

Opaque white aqueous suspension, contained in a labelled 20 mL amber glass vial sealed with a

rubber stopper and aluminium cap, packaged in a labelled outer carton.

pH:

4.0 - 7.5

Boiling Point/Melting Point:

Not determined

Vapour Pressure:

Not determined

Specific Gravity:

Not determined

Flashpoint:

Not determined

Flammability Limits:

Not determined

Solubility in Water:

Miscible in water

Other Properties:

No other information

Ingredients:

Chemical Name

CAS Number

Proportion

Testosterone

58-22-0

10% (100 mg/mL)

Benzyl Alcohol

100-51-6

less than 10%

Ingredients determined not to be hazardous

to 100%

HEALTH HAZARD INFORMATION

Health Effects:

Acute:

intraperitoneal, rat

326 mg/kg

intraperitoneal, rat

325 mg/kg

Category 2 carcinogen

Anabolic steroids give rise to side effects related to their androgenic or anabolic effects. High doses of

androgens may cause altered liver function with jaundice, fluid retention, high blood cholesterol, and

occasionally enhanced red blood cell production. Androgens also may cause masculinization in

women and gynecomastia (breast development) in men.

Swallowed:

Health effects may occur following oral ingestion.

Eye:

Page

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Material Safety Data Sheet

RWR Testosterone Suspension 100 Injection

May cause transient eye irritation.

Skin:

Accidental absorption of significant amounts of Testosterone Suspension through intact skin is

unlikely; however care should be taken during handling.

Inhaled:

Absorption via inhalation of Testosterone Suspension is unlikely.

Chronic:

The most likely source of chronic exposure to Testosterone Suspension is by unauthorised self-

injection.

Prolonged exposure may cause cancer. Androgens may accumulate and reach high levels even if

exposure is intermittent. Prolonged or repeated exposure may result in acne and development of

prominent musculature and veins, and these effects may be more prominent in women. In men low

sperm production and impotence may occur. In some men who have been androgen deficient the

administration of testosterone may cause an increase in the size of the prostrate gland and resultant

urinary obstruction. In women development of excessive facial and body hair, deepening of the voice,

irregularities of the menstrual cycle, baldness, and hypertrophy (enlargement) of the clitoris may

occur, and such changes may be irreversible. In children serious growth disturbances, premature

sexual and bone development may occur. Liver cancer (adenocarcinoma) has been reported.

First Aid:

Swallowed:

No specific first aid directions. Treat symptomatically and supportively.

Eye:

If in eyes, hold eyes open and flood with water for at least 15 minutes.

Skin:

If skin contact occurs, remove contaminated clothing and wash skin thoroughly.

Inhaled:

No specific first aid directions.

First Aid Facilities:

No specific first aid facilities required.

Advice to Doctor:

No specific advice.

Page

of 4

Material Safety Data Sheet

RWR Testosterone Suspension 100 Injection

PRECAUTIONS FOR USE

Exposure Standards:

None allocated

Engineering Controls:

No specific engineering controls required.

Personal Protection:

Appropriate protective clothing should be worn when handling.

Flammability:

Not considered flammable.

SAFE HANDLING INFORMATION

Storage and Transport:

Store below 25

C. Protect from light.

Spills and Disposal:

Appropriate protective clothing, including rubber gloves should be worn during cleanup operations.

Clean up spilt material using adsorbent material. Dispose of waste in accordance with local, state and

federal laws.

Fire/Explosion Hazard:

Not considered a fire or explosion hazard.

CONTACT POINT

RWR Veterinary Products Pty Ltd or Technical Services Manager

(02) 49616422

This information has been collated by technical personnel employing data available from the prime

manufacturer of the material. To the best of our knowledge it is true and accurate. It is not intended to

be all inclusive and the manner and conditions of use and handling may involve other or additional

considerations.

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