Target Species
Dogs (bitch).
Indications for use
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
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 veterinary medicinal product.
The use of veterinary medicinal product is contraindicated during pregnancy, lactation and in animals younger than 1 year.
Special warnings for each target species
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Special precautions for use
In case of oestrogenic effects, the dose should be lowered.
Special precautions for the protection of the environment
Not applicable.
Operator warnings
Not applicable.
Adverse Reactions
Dog (bitch):
Very common (> 1 animal / 10 animals treated): | Swollen vulva1,2, mammary gland oedema1,2, attractiveness to males1,2. Vomiting1,2. |
Rare (1 to 10 animals / 10 000 animals treated): | Vaginal haemorrhage. Alopecia. |
1 Observed at the highest recommended dose of 2 mg per dog.
2 These effects are reversible after lowering the dose.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
The use is not recommended during pregnancy or lactation.
Interactions
None known.
Amounts to be administered and administration route
For oral use only.
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 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.
Overdose
In case of overdose, typical oestrogen effects may occur. These effects are reversible after lowering the dose.
Withdrawal periods
Not applicable.