INCURIN 1MG 30 TABLETS

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    Qualitative and quantitative composition Active ingredients and excipients to notable effects:
    ..... Estriol 1 mg
    Excipient qs 1 tablet .....

    Pharmaceutical form:
    Scored round tablets.

    Target species:
    Dogs (bitches).

    Indications for use, specifying the target species:
    In ovariohystérectomisées bitches:
    - Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence.

    Cons-indications:
    Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitch.
    Animals showing a polyuria-polydipsia should not be treated with INCURIN®.
    The use of INCURIN® is against-indicated during pregnancy and lactation and in older bitches less than a year.

    Special warnings for each target species:
    Large doses of estrogen may have a tumor-promoting effect in target organs with estrogen receptors (mammary glands).

    Special precautions for use in animals:
    If estrogenic effects, reduce the dose.

    Special precautions to be taken by the person administering the veterinary medicinal product to animals:
    Not applicable.

    Adverse reactions (frequency and seriousness):
    Oestrogenic effects such as swollen vulva, breast edema 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 were observed. In rare cases development of alopecia has also been observed.

    Use during pregnancy and lactation:
    Do not use this product during pregnancy or lactation.
    Also see "Contraindications".

    Drug interactions and other:
    None known.

    Dosage:
    No relationship between effective final dose and body weight has been established. The dose must be determined individually for each dog.

    The following treatment program is advised:
    start treatment with 1 tablet (1 mg estriol) per day. If the treatment is effective, reduce the dose to half a tablet a day. If the treatment is not efficient, increasing the dose to two tablets per day to be administered once daily.
    Some dogs do not need daily administration; an administration every two days may be considered once the specified daily dose.

    The minimum dose should not be less than 0.5 mg per dog per day.
    Ensure the dose used to achieve the therapeutic effect is as small as possible.
    Do not administer more than 2 tablets per dog per day.
    If no response to treatment has been obtained, the diagnosis should be reconsidered in order to find other causes of incontinence such as neurological disorders, bladder cancer, etc.
    Animals must be reviewed every 6 months during treatment.

    route:
    Oral use.

    Overdose (symptoms, emergency procedures, antidotes):
    In case of overdose, estrogen-like effects can be observed. These effects are reversible after lowering the dose.

    Waiting time:
    Not applicable.

    Pharmacodynamic properties:
    Estriol is a natural estrogen short duration of action. It has a beneficial effect on urinary incontinence in ovariectomized bitches.
    During tolerance studies in the target animal and clinical trials including long-term treatment, no signs of bone marrow suppression were observed. The positive point is probably due to the short duration of action of estrogen estriol.

    Pharmacokinetic:
    After oral administration estriol is almost completely absorbed from the gastrointestinal tract. Most of estriol is bound to plasma albumin. Estriol is excreted in the urine conjugate.
    There is no accumulation after repeated oral administration.

    Incompatibilities:
    Any.

    Retention period:
    3 years.

    Special storage by relevance:
    Store at a temperature not exceeding 30 ° C.

    Special precautions when disposing of unused medicines or waste materials derived from the use of these medicines:
    Any unused product or waste materials derived from these medications should be disposed of in accordance with local requirements.

    Authorization holder of the marketing / operator:
    Marketing Authorisation Holder:
    INTERVET INTERNATIONAL BV
    Wim de Körverstraat 35
    5831 AN Boxmeer 4
    NETHERLANDS

    Operator:
    INTERVET
    Rue Olivier de Serres
    BP 17144
    49071 cedex BEAUCOUZE

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