Riik: Portugal
keel: inglise
Allikas: HMA (Heads of Medicines Agencies)
ceftiofur hydrochloride 50 mg/ml
Alfasan Nederland B.V.
QJ01DD90
Suspension for injection
Ceftiofur
Cattle, Pigs
2011-02-23
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:. Active substance: Ceftiofur (as hydrochloride) 50.0 mg Excipients: For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. White to off white coloured suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs weighing up to 125 kg. Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections associated with bacteria sensitive to ceftiofur: In pigs: -Treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus _ _pleuropneumoniae _and _Streptococcus suis_. This product is not to be used in pigs with a bodyweight more than 125 kg. In cattle: -Treatment of bacterial respiratory disease associated with_ Mannheimia haemolytica_, _Pasteurella _ _multocida _and _Haemophilus somnus_. -Treatment of acute interdigital necrobacillosis (panaritium, foul in the foot), associated with _Fusobacterium necrophorum _and _Bacteroides melaninogenicus _(_Porphyromonas asaccharolytica_). -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 failed_ _ _ _ 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not administer to an animal previously found to be hypersensitive to cefti Lugege kogu dokumenti