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Incurin
Estriol


PACKAGE LEAFLET


INCURIN 1 mg tablet


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder and manufacturer responsible for batch release:


    Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

    The Netherlands


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    INCURIN 1 mg tablet Estriol


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS


    Active substance: estriol 1 mg/tablet Round single-scored tablets.


  4. INDICATION


    Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.


  5. 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.

    The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year.


  6. ADVERSE REACTIONS


    Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg. These effects are reversible after lowering the dose. Further, in some dogs, symptoms of nausea were observed. Because of its short-acting oestrogenic properties, Incurin does not induce bone marrow suppression in the dog.

    In rare cases vaginal bleeding occurred. In rare cases development of alopecia has also been observed.


    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

  7. TARGET SPECIES


    Dog.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Incurin is intended for once daily oral administration.

    Since there exists no relation between the final effective dose and the body weight, a fixed dose per kg body weight is not feasible. The dose has to be fixed for each dog on an individual basis. The

    following dosing schedule is advised: start treatment with 1 tablet 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. Some dogs do not need daily treatment; treatment every other day may be tried once the effective daily dose has been established.


  9. ADVICE ON CORRECT ADMINISTRATION


    Not applicable.


  10. WITHDRAWAL PERIOD


    Not applicable.


  11. SPECIAL STORAGE CONDITIONS

    Keep out of the reach and sight of children. Do not store above 30°C.

    Do not use after the expiry date which is stated on the label after Exp.


  12. SPECIAL WARNINGS


    High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).

    In case of overdose typical oestrogen effects may occur. These effects are reversible after lowering the dose.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


  15. OTHER INFORMATION


Each push-through strip contains 30 tablets. Each strip is packed in a carton box.

Oestriol is a short-acting natural oestrogen. In the incontinent female dog it has a beneficial effect on the urinary incontinence. Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing. Because of its short acting action, oestriol does not induce bone marrow suppression in the dog.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.