Țară: Irlanda
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
ceftiofur hydrochloride 50 mg/ml
CEVA Sante Animale
QJ01DD90
Suspension for injection
Ceftiofur
Cattle, Pigs
2012-02-13
1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE CARDBOARD BOXES OF 100 & 250 ML VIALS OF 100 & 250 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs Ceftiofur 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 vial contains: Ceftiofur (as hydrochloride) 50 mg/ml 3. PHARMACEUTICAL FORM Suspension for injection. 4. PACKAGE SIZE 100 ml 250 ml 5. TARGET SPECIES Cattle and pigs. 6. INDICATION(S) Read the package leaflet before use and disposal. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: Subcutaneous use. Pigs: Intramuscular use. Read the package leaflet before use and disposal. 3 8. WITHDRAWAL PERIOD MEAT & OFFAL: Pigs: 5 days. Cattle: 8 days MILK: 0 hours 9. SPECIAL WARNING(S), IF NECESSARY Penicillins and cephalosporins may occasionally cause severe allergic reactions. See package leaflet for user warnings. 10. EXPIRY DATE EXP: Once broached, use by: ___/___/___ Shelf-life after first opening: 28 days. 11. SPECIAL STORAGE CONDITIONS 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 Read package leaflet before use and disposal. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep ou Citiți documentul complet
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains: ACTIVE SUBSTANCE: Ceftiofur (as hydrochloride) 50 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Oily beige suspension for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections associated with bacteria sensitive to ceftiofur. IN CATTLE: For the treatment of bacterial respiratory disease associated with _Pasteurella multocida, _ _Mannheimia haemolytica _and _Haemophilus somnus_. For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with _Fusobacterium _ _necrophorum _ and _Bacteroides _ _melaninogenicus _ (_Porphyromonas _ _asaccharolytica_). For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with _Escherichia coli_, _Arcanobacterium pyogenes _and _Fusobacterium _ _necrophorum_: : this indication is restricted to cases where treatment with another antimicrobial has failed. IN PIGS: For the treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus pleuropneumoniae _and _Streptococcus suis_. 4.3 CONTRAINDICATIONS Do not administer to an animal previously found to be hypersensitive to ceftiofur and other -lactam antibiotics. Do not Citiți documentul complet