TARDAK ANDROGEN INHIBITIVE SUSPENSION
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
DELMADINONE ACETATE
Available from:
JUROX PTY LIMITED
INN (International Name):
delmadinone as acetate(8.7mg/mL)
Pharmaceutical form:
TOPICAL SOLUTION/SUSPENSION
Composition:
DELMADINONE ACETATE STEROID-PROGESTIN Active 10.0 mg/ml
Units in package:
10mL
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG - MALE
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
CANINE PROSTATIC HYPERTROPHY | CIRCUM-ANAL TUMOURS | MODIFY HYPERSEXUALITY | EXCESS LIBIDO - REDUCE
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - MALE: [CANINE PROSTATIC HYPERTROPHY, CIRCUM-ANAL TUMOURS, MODIFY HYPERSEXUALITY]; For the modification of hypersexuality in the male dog and the treatment of canine prostatic hypertrophy and circum-anal tumours.Care should be exercised in dogs receiving additional steroid therapy. Do not use in animals with a history of poor fertility or lack of libido if such dogs are to be subsequently used at stud.
Authorization status:
Registered
Authorization date:
2023-07-01
Summary of Product characteristics
TARDAK SUSPENSION
Page 1 of 5
continued
ISSUED:
13 AUGUST 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
TARDAK SUSPENSION
PRODUCT CODE:
60990 (10 mL)
RECOMMENDED USE:
Injection for the modification of hypersexuality in the male dog and
the
treatment of canine prostate hypertrophy and circumanal tumours.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
REPRODUCTIVE TOXICITY CATEGORY 2
SKIN SENSITISER CATEGORY 1
GHS PICTOGRAMS:
EXCLAMATION MARK
HEALTH HAZARD
SIGNAL WORD:*
WARNING
HAZARD STATEMENTS:*
H317
May cause an allergic skin reaction.
H361
Suspected of damaging fertility or the unborn child.
PRECAUTIONARY STATEMENTS:*
PREVENTION
P201
Obtain special instructions before use.
P202
Do not handle until all safety precautions have been read and
understood.
P261
Avoid breathing vapours.
P272
Contaminated work clothing should not be allowed out of the workplace.
P280
Wear protective gloves e.g. PVC or vinyl and protective eyewear e.g.
Safety
glasses with eye side shields or chemical goggles.
P281
Use personal protective equipment as required.
RESPONSE
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P308+P313
IF exposed or concerned: Get medical advice/attention.
P333+P313
If skin irritation or rash occurs: Get medical advice/attention.
P363
Wash contaminated clothing before reuse.
STORAGE
P405
Store locked up.
DISPOSAL
P501
Dispose of contents/container in accordance with local/national
regulations.
* N.B.: These statements are determined by Work Health and Safety
regulations and may not reflect Signal Headings and
First Aid and Safety statements on product labelling, which are
determined by a competent authority during assessment
for registration.
TARDAK SUSPENSION
Page 2 of 5
continued
SECTION 3: CO
Read the complete document
