Ülke: Macaristan
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
spiramycin 600000 IU
CEVA Santé Animale
QJ01FA02
Solution for injection
spiramycin
Cattle, Pigs
2012-06-27
1/6 Dokument190 June. 12 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2/6 Dokument190 June. 12 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SPIROVET 600 000 IU/ml solution for injection for cattle and pigs [BG, CZ, EE, HU, IE, LT, LV, PL, PT, SI, SK, UK] SPIRAMYCINE CEVA 600 000 IU/ml, solution for injection for cattle and pigs [FR] SPIROCIN 600 000 IU/ml, solution for injection for cattle and pigs [DK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains : ACTIVE SUBSTANCE: Spiramycin..................................................600 000 IU EXCIPIENT: Benzyl alcohol (E 1519) ...............................41.6 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Diseases caused by spiramycin susceptible bacteria. CATTLE (ADULTS): Treatment of: - Respiratory diseases, - Mastitis, - Metritis, - Interdigital necrobacillosis (foul in the foot). SOWS: Treatment of mastitis. 4.3 CONTRAINDICATIONS Do not use in animals known for their hypersensitivity to spiramycin or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 3/6 Dokument190 June. 12 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS In cattle, do not administer more than 15 ml per injection site. In sows, do not administer more than 7 ml per injection site. Due to the likely variability (time, geographical) in the occurrence of resistance of bact Belgenin tamamını okuyun