Страна: Италия
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
ceftiofur hydrochloride 50 mg/ml
LAB. E IND. IVEN
QJ01DD90
Suspension for injection
Ceftiofur
Cattle Food, Pigs Food
2011-06-28
CEFTIONIL, 50 mg/ ml, suspension for in jection for p igs and cattle - Product Informat ion - March 2012 1/14 1.B.2 LABELLING AND PACKAGE LEAFLET PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 100 ml and 250 ml. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEFTIONIL, 50 mg/ml, suspension for injection, for pigs and cattle Ceftiofur (as ceftiofur hydrochloride) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES One ml contains: Ceftiofur (as ceftiofur hydrochloride) .......... 50 mg Excipients, q.s. ..............................................1 ml 3. PHARMACEUTICAL FORM Suspension for injection. 4. PACKAGE SIZE 100 ml 250 ml 5. TARGET SPECIES Pigs and cattle 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Pigs: Intramuscular use Cattle: Subcutaneous injection Shake well before use Read the package leaflet before use 8. WITHDRAWAL PERIOD Pigs: Meat and offal: 5 days. CEFTIONIL, 50 mg/ ml, suspension for in jection for p igs and cattle - Product Informat ion - March 2012 2/14 Cattle: - Meat and offal: 8 days - Milk: zero days. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP: MM/YYYY Shelf life after first opening the immediate packaging: 28 days 11. SPECIAL STORAGE CONDITIONS 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDIT Прочитать полный документ
CEFTIONIL, 50 mg/ ml, suspension for in jection for p igs and cattle – SPC Proposal – March 2012 1/6 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ceftionil, 50 mg/ml, suspension for injection for pigs and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Ceftiofur (as ceftiofur hydrochloride) 50.0 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. A white or slightly yellow coloured opaque suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections associated with bacteria sensitive to ceftiofur: In pigs: - For the treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus pleuropneumoniae _and _Streptococcus suis_. In cattle: - For the treatment of bacterial respiratory disease associated with _Mannheimia _ _haemolytica_, _Pasteurella multocida _and _Haemophilus sommus_. - 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_, sensitive to ceftiofur_._ The indication is restricted to cases where treatment with another antimicrobial has Прочитать полный документ