INCURIN

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OESTRIOL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

oestriol(1mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

OESTRIOL HORMONE Active 1.0 mg/Tb

Units in package:

30 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

DOG - BITCH - OVARIOHYSTERECTOMISED

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

INCONTINENCE - HORMONE RESPONSIVE

Product summary:

Poison schedule: 4; Withholding period: WHP:N/A; Host/pest details: DOG - BITCH - OVARIOHYSTERECTOMISED: [INCONTINENCE - HORMONE RESPONSIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - BITCH - OVARIOHYSTERECTOMISED: [INCONTINENCE - HORMONE RESPONSIVE]; An aid in the treatment of hormone-responsive urinary incontinence due to sphincter mechanism in ovariohysterectomised bitches.Do not use in intact bitches. See leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

An aid in the treatment of hormone-responsive urinary incontinence due
to sphincter mechanism incompetence in
ovariohysterectomised bitches.
30 Tablets
INTERVET AUSTRALIA PTY LIMITED
91-105 Harpin Street, BENDIGO EAST VIC 3550
Phone: [phone]
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
Do not use in intact bitches as the
efficacy has only been established in
ovariohysterectomised bitches.
Animals showing a polyuria-polydipsia
should not be treated with INCURIN
®
.
Excretion is primarily via the bile.
Use with caution in animals with liver
disease.
SIDE EFFECTS:
High doses of oestrogen may have a
tumour promoting effect in target
organs with oestrogen receptors
(mammary gland).
Oestrogenic effects such as swollen
vulva, swollen mammary glands
and/or attractiveness to males and
vomiting have been observed at the
highest recommended dose of 2 mg
per dog. The incidence is about 5-9%.
These effects are reversible after
lowering the dose.
In rare cases vaginal bleeding occurred.
Alopecia is a potential side effect,
particularly with long term use.
DOSAGE AND ADMINISTRATION:
For oral administration.
FIRST AID:
If poisoning occurs, contact a doctor or
Poisons Information Centre.
Phone Australia 131126.
DISPOSAL:
Dispose of empty container by
wrapping with paper and putting in
garbage.
STORAGE:
Store below 30°C (Room temperature).
APVMA Approval No.: 57787/30T/0904
0497573A
5150.880.2961
Batch No. :
Expiry Date :
INCURIN
®
ACTIVE CONSTITUENT:
OESTRIOL, 1 mg/TABLET
049573A
5150 / 328
INCURIN
®
ACTIVE CONSTITUENT: OESTRIOL, 1 mg/TABLET
INCURIN
®
ACTIVE CONSTITUENT: OESTRIOL, 1 mg/TABLET
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
042/5150/880/049573A 09-11-2004 14:38 Pagina 1
Info
PEST


Verified
GENERAL DIRECTIONS:
Oestriol is a short-acting natural oestrogen.
After oral administration of multiple doses no accumulation occurs. In
the target
animal safety study and the clinical trials, including long-term
treatment, no signs of

Summary of Product characteristics

PRODUCT NAME: INCURIN®
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Oestriol is an estrogen compound.
TRADE NAME:
INCURIN
®
PRODUCT CODE:
68038
RECOMMENDED USE:
Incontinence treatment for female dogs.
APVMA NO:
57787
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:
S20, S45. When using, do not eat or drink. 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:
White tablets.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Long term inhalation of high amounts of any nuisance dust may overload
lung clearance
mechanism. 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 with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, but is unlikely to
cause anything more tha