País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CEFTIOFUR (AS HYDROCHLORIDE)
Zoetis Ireland Limited
QJ01DD90
CEFTIOFUR (AS HYDROCHLORIDE)
50 Mg/Ml
Suspension for Injection
POM
Bovine, Porcine
Ceftiofur
Antibacterial
Authorised
2013-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Excenel Flow, 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 EXCIPIENT(S): For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Opaque suspension, white to off-white. 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_ (former_ Pasteurella_ _haemolytica_),_ Pasteurella multocida_ and_ Histophilus somni_ (former_ 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_, sensitive to ceftiofur, were treatment with another antimicrobial has failed. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7 Leia o documento completo