Země: Rakousko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
ceftiofur sodium salt 50 mg/ml
CEVA Animal Health
QJ01DD90
Powder and solvent for solution for injection
Ceftiofur
Cattle, Pigs
2012-02-13
1/19 C577-cevaxel-labelling-varIA-day0 March 12 A. LABELLING 2/19 C577-cevaxel-labelling-varIA-day0 March 12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box containing 1 vial of CEVAXEL 50 mg/ml, 1 g 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAXEL 50 mg/ml, powder and solvent for solution for injection for cattle and pigs. Ceftiofur (as sodium) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ceftiofur (as sodium) 1 g 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection 4. PACKAGE SIZE 1 g 5. TARGET SPECIES Cattle and pigs. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Method and route of administration: read the package leaflet before use. 8. WITHDRAWAL PERIOD Meat and offal: - Cattle: 2 days - Pigs: 2 days. Milk: zero days. 9. SPECIAL WARNING(S), IF NECESSARY Penicillins and cephalosporins may occasionally cause severe allergic reactions. See package leaflet for user warnings. 3/19 C577-cevaxel-labelling-varIA-day0 March 12 10. EXPIRY DATE EXP: “Once reconstituted, use by------ (7 days, stored in a refrigerator, 12 hours, stored below 25°C) Once broached, use by 11. SPECIAL STORAGE CONDITIONS Stored in a refrigerator (2 °C- 8°C) Keep the vial in the outer carton in order to protect from light 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only T Přečtěte si celý dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cevaxel 50 mg/ml powder and solvent for solution for injection for cattle and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _One powder vial of 1 g contains: _ Active substance: Ceftiofur (as sodium).......................................................................................1 g _One powder vial of 4 g contains: _ Active substance: Ceftiofur (as sodium).......................................................................................4 g _One ml solvent contains _ Water for injections ....................................................................................... 1 ml _1 ml of reconstituted solution contains: _ Active substance: Ceftiofur (as sodium).................................................................................. 50 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: white to off white powder. Solvent: clear and colourless liquid. Reconstituted solution: clear brownish yellow to yellow coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: - For the treatment of bacterial respiratory disease associated with _Pasteurella multocida _and_ _ _Mannheimia haemolytica _sensitive_ to _ceftiofur_. _ - For the treatment of cattle with interdigital necrobacillosis (foot rot) in which _Fusobacterium _ _necrophorum _and _Bacteroides melaninogenicus (Porphyromonas asaccharolytica) _sensitive to ceftiofur_ _are_ _involved. PIGS: - For the treatment of bacterial respiratory disease i Přečtěte si celý dokument