Incurin Data Sheet
Estriol, 1 mg per tabletPresentation
Scored tablets for oral administration. Each tablet contains 1 mg Estriol Ph.Eur.
Uses
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Dosage and administration
For oral administration.
A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis.
The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day. If treatment is successful, lower the dose to half a tablet a day. If initial treatment is not successful, increase the dose to 2 tablets a day to be given in one dose. Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established.
The minimum dose given should not be less than 0.5 mg per dog per day. Ensure the dose used to achieve the therapeutic effect is as low as possible. Do not use more than 2 tablets per dog per day. If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc.
Animals should be re-examined every 6 months during treatment.
Contra-indications, warnings etc.
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Animals showing a polyuria-polydipsia syndrome should not be treated with Incurin.
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.
In very rare cases development of alopecia has also been observed.
In case of oestrogenic effects, the dose should be lowered.
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary gland).
Withdrawal period:
Not applicable.
FOR ANIMAL TREATMENT ONLY.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Pharmaceutical precautions
Do not store above 30 °C.
Any unused veterinary medicinal product or waste material derived from such product should be disposed of in accordance with local requirements.
Legal category
POM-V To be supplied only on veterinary prescription. |
Package quantities
Blister packs of 30 tablets.
Further Information
Estriol 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 bone marrow suppression were observed. This is probably due to the short-acting oestrogenic character of estriol.
Marketing authorisation number
EU/2/00/018/001
Marketing Authorisation holder
Intervet International B.V.
Represented in the UK by:
IntervetUK Ltd.
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
Date of text preparation:
December 2006.
Item code: 047853 61400.Feb.2007/MP/7k
Company
