Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
ceftiofur hydrochloride 50 mg/ml
Laboratorios Syva SA
QJ01DD90
Suspension for injection
Ceftiofur
Cattle, Pigs
2011-02-23
_ACTIONIS_ _Ceftiofur_ _ _ _50 mg/ml Suspension for injection _ PART 1B February-2011 1 ACTIONIS PART 1B SUMMARY OF PRODUCT CHARACTERISTICS, LABEL AND PACKAGE INSERT _ACTIONIS_ _Ceftiofur_ _ _ _50 mg/ml Suspension for injection _ PART 1B February-2010 2 PART 1 B1 – SUMMARY OF PRODUCT CHARACTERISTICS _ _ 3 _ _ _[Version 7.2, 12/2008] _ SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actionis 50 mg/ml, suspension for injection for pigs and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ceftiofur (as ceftiofur hydrochloride) 50.0 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection White to pale yellow oily 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 _Histophilus somni_. -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 _Fusoba Read the complete document
_[Version 7.3.2, 10/2011] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actionis 50 mg/ml, suspension for injection for pigs and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ceftiofur (as ceftiofur hydrochloride) 50.0 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White to pale yellow oily 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 _Histophilus somni_. -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 failed. 4.3 CONTRAINDICATIONS Do not administer to an animal previously found to be hypersensitive to ceftiofur and other -lactam antibiot Read the complete document