Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
estriol
Intervet International BV
QG03CA04
Estriol
Dogs
Sex hormones and modulators of the genital system
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Revision: 7
Authorised
2000-03-24
13 B. PACKAGE LEAFLET 14 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. 15 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 tabl Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY 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. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) 3 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 effect Lugege kogu dokumenti