SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 The European Agency for the Evaluation of Medicinal Products ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Switchboard: ( ) Fax: ( ) E_Mail: mail@emea.eudra.org

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Incurin 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s) 1 mg estriol per tablet Excipient(s) knowledge of which is essential for the proper administration of the veterinary medicinal product None 3. PHARMACEUTICAL FORM Tablet 4. PHARMACOLOGICAL PROPERTIES Estriol is a short-acting natural oestrogen. After oral administration of multiple doses no accumulation occurs. 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. Incurin -Tablet -EN 1

3 5. CLINICAL PARTICULARS 5.0 Target species Dogs (bitches) 5.1 Indications for use The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches. 5.2 Contraindications Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia syndrome should not be treated with Incurin. 5.3 Undesirable effects 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. 5.4 Special precautions for use In case of oestrogenic effects the dose should be lowered. 5.5 Use during pregnancy and lactation Not applicable. 5.6 Interaction with other medicaments and forms of interaction Incurin -Tablet -EN 2

4 None known. 5.7 Posology and method of administration 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 initial 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. 5.8 Overdose In case of overdose typical oestrogenic effects may occur. These effects are reversible after lowering the dose. 5.9 Special warnings for each target species High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary gland) Withdrawal period Not applicable 5.11 Special precautions to be taken by the person administering the veterinary medicinal product to animals Incurin -Tablet -EN 3

5 None Incurin -Tablet -EN 4

6 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities Not applicable 6.2 Shelf-life 3 years 6.3 Special precautions for storage Do not store above 30 C 6.4 Nature and contents of container 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. 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such medicinal products, if appropriate Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 7. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER Intervet International B.V. Wim de Körverstraat AN BOXMEER Incurin -Tablet -EN 5

7 The Netherlands 8. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION 10. DATE OF REVISION OF THE TEXT Incurin -Tablet -EN 6

8 ANNEX II THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE AND CONDITIONS OF THE MARKETING AUTHORISATION Incurin -Tablet -EN 7

9 A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Intervet International B.V. Wim de Körverstraat AN Boxmeer The Netherlands Manufacturing Authorisation no as granted by the Ministerie van Landbouw, Natuurbeheer en Visserij on 30 May 1995 has been presented. GMP status was confirmed by the Inspectie voor de Gezondheit of the Staatstoezicht Op De Volksgezondheid on 29 April 1997, following an inspection on April B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. D. STATEMENT OF THE MRLs Not applicable. Incurin -Tablet -EN 8

10 Incurin -Tablet -EN 9

11 ANNEX III LABELLING AND PACKAGE INSERT Incurin -Tablet -EN 10

12 A. LABELLING Incurin -Tablet -EN 11

13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Incurin 1 mg tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Estriol, 1 mg/tablet 3. PHARMACEUTICAL FORM Tablets 4. PACKAGE SIZE 30 tablets 5. TARGET SPECIES Dogs (bitches) Incurin -Tablet -EN 12

14 6. INDICATION(S) Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary gland). 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. Incurin -Tablet -EN 13

15 10. EXPIRY DATE Month/year 11. SPECIAL STORAGE CONDITIONS Do not store above 30 C. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. 13. THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only 14. THE WORDS"KEEP OUT OF REACH AND SIGHT OF CHILDREN" Keep out of reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Incurin -Tablet -EN 14

16 Intervet International B.V. Wim de Körverstraat AN Boxmeer The Netherlands 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 17. MANUFACTURER'S BATCH NUMBER 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription Incurin -Tablet -EN 15

17 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Incurin 1mg tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Estriol, 1 mg 3. NAME OF THE MARKETING AUTHORISATION HOLDER Intervet 4. THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only 5. MANUFACTURER S BATCH NUMBER Batch Incurin -Tablet -EN 16

18 6. EXPIRY DATE EXP month/year Incurin -Tablet -EN 17

19 B. PACKAGE INSERT Incurin -Tablet -EN 18

20 PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Incurin 1 mg tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Estriol, 1 mg per tablet 3. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Intervet International B.V. Wim de Körverstraat AN Boxmeer The Netherlands 4. TARGET SPECIES Dogs (bitches) 5. INDICATION(S) Incurin -Tablet -EN 19

21 The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches. 6. DOSAGE FOR EACH SPECIES 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 initial 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. Incurin -Tablet -EN 20

22 7. METHOD AND ROUTE(S) OF ADMINISTRATION Incurin is intended for oral administration, once daily or every other day. 8. ADVICE ON CORRECT ADMINISTRATION Not applicable. 9. CONTRA-INDICATIONS Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia syndrome should not be treated with Incurin. 10. UNDESIRABLE EFFECTS 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. 11. WITHDRAWAL PERIOD Not applicable 12. SPECIAL STORAGE CONDITIONS, IF ANY Incurin -Tablet -EN 21

23 Do not store above 30 C 13. SPECIAL WARNING(S), IF NECESSARY High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary gland). 14. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste materials should be disposed of in accordance with local requirements. 15. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED Incurin -Tablet -EN 22

24 16. OTHER INFORMATION Estriol is a short-acting natural oestrogen. After oral administration of multiple doses no accumulation occurs. 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. For any information about this veterinary product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Intervet België N.V. Ragheno Park, Dellingstraat 32/1 B-2800 MECHELEN Tél/Tel: Luxembourg/Luxemburg Intervet België N.V. Ragheno Park, Dellingstraat 32/1 B-2800 MECHELEN Tél/Tel: Danmark INTERVET SCANDINAVIA Literbuen 9 DK-2740 SKOVLUNDE Tlf: Nederland Mycofarm Nederland B.V. Ambachtstraat 4 NL-3732 CN DE BILT Tel: Deutschland INTERVET GmbH Tackweg 11 D TÖNISVORST Tel: Österreich Intervet GesmbH Siebenbrunnengasse 21/D/IV A-1050 WIEN Tel: Ελλάδα 1. Ιντερβέτ Ελλάς ΑΕ Παπαρρηγοπούλου 3 GR Χαλάνδρι, Αθήνα Τηλ: Portugal INTERVET PORTUGUESA LDA. Av. Conde Valbom 30-1, 2 e 3 P-1050 LISBOA Tel: Incurin -Tablet -EN 23

25 España LABÓRATORIOS INTERVET S.A. Polígono Industrial "El Montalvo" Apartado 3006 E-SALAMANCA Tel: Suomi/Finland INTERVET FENNICA Tuotekatu 7 FIN RAISIO Puh/Tln: France INTERVET S.A. 43, Avenue Joxé F ANGERS Cedex Tél: Sverige Intervet AB Box 5076 S VÄSTRA FRÖLUNDA Tln: Ireland INTERVET IRELAND Ltd. Farnham Drive Finglas IRL-DUBLIN 11 Tel: United Kingdom INTERVET UK Ltd. Science Park Milton Road UK - CAMBRIDGE CB4 OFP Tel: Incurin -Tablet -EN 24

26 Italia INTERVET ITALIA S.r.l. Via Brembo 27 I MILANO Tel: Incurin -Tablet -EN 25