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Incurin

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Summary for the public


What is Incurin?

Incurin is a tablet containing the natural hormone estriol as active substance.


What is Incurin used for?

Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically).

As the sensitivity of incontinent dogs to estriol is variable, the dose has to be determined on an individual basis. For advise on dosing please see the Package Leaflet.


How does Incurin work?

Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.

The term urinary incontinence is used to describe the condition of involuntary leakage of urine. It is known to occur in bitches, with the incidence being highest after ovariectomy. This condition is accompanied with a decrease of the endogenous oestrogen production. Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion. Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.


How has Incurin been studied?

Incurin has been studied in bitches in three large field trials. During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.

The studies also established that there is no apparent relationship between the dosage and the body weight of the dog – therefore the dosing has to be decided on an individual basis.


What benefit has Incurin shown during the studies?

The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term. The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.


What is the risk associated with Incurin?

Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.

Effects typical to oestrogens 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 (loss of hair) has also been observed.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

No special precautions are necessary when administering Incurin.


Why has Incurin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Incurin

The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B.V. on 24 March 2000 and renewed in it 2005. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Incurin
EMEA Product number: EMEA/V/C/000047
Active substance: estriol
INN or common name: Estriol
Species: Dogs
ATCvet Code: QG03CA04
Marketing Authorisation Holder: Intervet International BV
Revision: 5
Date of issue of Market Authorisation valid throughout the European Union: 24/03/2000
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    SUMMARY OF PRODUCT CHARACTERISTICS
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    INCURIN 1 mg tablet
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance: estriol
    1 mg/tablet
    For a full list of excipients, see section 6.1
    3.
    PHARMACEUTICAL FORM
    Round single-scored tablets
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs (bitches).
    4.2 Indications for use, specifying the target species
    The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence
    in ovariohysterectomised bitches.
    4.3 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.
    4.4 Special warnings for each target species
    High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors
    (mammary glands).
    4.5 Special precautions for use
    Special precautions for use in animals
    In case of oestrogenic effects, the dose should be lowered.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Not applicable.
    2/15
     
    4.6 Adverse reactions (frequency and seriousness)
    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 rare cases development of alopecia has also been observed.
    4.7 Use during pregnancy, lactation or lay
    Do not use this product during pregnancy or lactation. See also 4.3 Contraindications.
    4.8 Interaction with other medicinal products and other forms of interaction
    None known.
    4.9 Amount(s) to be administered and administration route
    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 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.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    In case of overdose typical oestrogen effects may occur. These effects are reversible after lowering the
    dose.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
    5.1 Pharmacodynamic properties
    Estriol is a short-acting natural oestrogen. In ovarioectomised female dogs it has a beneficial effect on
    urinary incontinence. 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.
    5.2 Pharmacokinetic particulars
    After oral administration Estriol is nearly completely absorbed from gastrointestinal tract. Nearly the
    whole Estriol is bound to Albumin in Plasma. Estriol is excreted in conjugated from via the urine.
    After oral administration of multiple doses no accumulation occurs.
    3/15
    6 PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Amylopectin
    Potato starch
    Magnesium stearate
    Lactose
    6.2 Incompatibilities
    None.
    6.3 Shelf life
    3 years.
    6.4 Special precautions for storage
    Do not store above 30 °C.
    6.5 Nature and composition of immediate packaging
    Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl
    copolymer) on the side in contact with the tablets. One blister contains 30 tablets.
    Pack size: carton box with 1 blister
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    product should be disposed of in accordance with local requirements.
    7
    MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/018/001.
    9
    DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
    Date of first authorisation: March 2000
    Date of last renewal: March 2010
    10 DATE OF REVISION OF THE TEXT
    March 2010
    4/15
     
    11 PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5/15
     
    ANNEX II
    A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND>
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D. STATEMENT OF THE MRLs
    6/15
     
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) of the biological active substance(s)
    N.V. Organon
    Kloosterstraat 6
    5349 AB Oss
    The Netherlands
    Name and address of the manufacturer(s) responsible for batch release
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D.
    STATEMENT OF THE MRLs
    Not applicable.
    7/15
    A. LABELLING
    8/15
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    CARTON BOX
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    INCURIN 1 mg tablet
    Estriol
    2.
    STATEMENT OF ACTIVE AND OTHER SUBTANCES
    Active substance: estriol 1 mg/tablet
    3.
    PHARMACEUTICAL FORM
    Tablet.
    4.
    PACKAGE SIZE
    Carton box with 1 blister. Each blister contains 30 tablets.
    5.
    TARGET SPECIES
    Dog.
    6.
    INDICATION(S)
    Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in
    female dogs.
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    For oral administration.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNINGS, IF NECESSARY
    Not applicable.
    9/15
     
    10. EXPIRY DATE
    Exp (Month / year)
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 30°C.
    12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    product should be disposed of in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    MA number.
    17. MANUFACTURER’S BATCH NUMBER
    Batch number.
    10/15
     
    MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    BLISTER
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    INCURIN 1 mg tablet.
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    3.
    EXPIRY DATE
    (Month / year)
    4.
    BATCH NUMBER
    Batch number.
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    11/15
     
    B. PACKAGE LEAFLET
    12/15
     
    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:
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer for the batch release :
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE 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.
    13/15
    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.
    14/15
     
    14.
    DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    March 2010
    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.
    15/15


    Source: European Medicines Agency


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