Riik: Holland
keel: inglise
Allikas: HMA (Heads of Medicines Agencies)
ceftiofur hydrochloride 50 mg/ml
Calier Portugal, S.A.
QJ01DD90
Suspension for injection
Ceftiofur
Cattle, Pigs
2011-04-02
PACKAGE LEAFLET CEFTIOMAX 50 mg/ml suspension for injection for swine and cattle [BG, CZ, EE, ES, HU, IT, LT, LV, PL, PT, RO, SK] READYCEF 50 mg/ml suspension for injection for swine and cattle [AT, BE, DE, EL, FR, NL, UK] 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) Les Franqueses del Vallès (Barcelona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CEFTIOMAX 50 mg/ml suspension for injection for swine and cattle [BG, CZ, EE, ES, HU, IT, LT, LV, PL, PT, RO, SK] READYCEF 50 mg/ml suspension for injection for swine and cattle [AT, BE, DE, EL, FR, NL, UK] Ceftiofur (as ceftiofur hydrochloride) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: Active substance: Ceftiofur (as ceftiofur hydrochloride) ... 50 mg 4. INDICATION(S) Swine: Treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus pleuropneumoniae _and _Streptococcus suis _sensitive to ceftiofur hydrochloride. Cattle: For the treatment of bacterial respiratory disease associated with _Mannheimia _ _haemolytica_ (former _Pasteurella haemolytica), Pasteurella multocida _and _Histophilus _ _somni_ (former _Haemophilus somnus_)_ _sensitive to ceftiofur hydrochloride. For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with _Fusobacterium necrophorum _and _Bacteroides melaninogenicus _(_Porphyromonas _ _asaccharolytica_) sensitive to ceftiofur hydrochloride. For the treatmen Lugege kogu dokumenti
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ceftiomax 50 mg/ml suspension for injection for swine and cattle [BG, CZ, EE, ES, HU, IT, LT, LV, PL, PT, RO, SK] READYCEF 50 mg/ml suspension for injection for swine and cattle [AT, BE, DE, EL, FR, NL, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Ceftiofur (as ceftiofur hydrochloride).... ……50 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. White to white-cream coloured oily suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Swine and cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Swine: - Treatment of bacterial respiratory disease associated with _Pasteurella multocida_, _Actinobacillus pleuropneumoniae _and _Streptococcus suis _sensitive to ceftiofur hydrochloride. Cattle: - For the treatment of bacterial respiratory disease associated with _Mannheimia _ _haemolytica_ (former _Pasteurella haemolytica), Pasteurella multocida _and _Histophilus _ _somni_ (former _Haemophilus somnus) _sensitive to ceftiofur hydrochloride. - For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with _Fusobacterium necrophorum _and _Bacteroides melaninogenicus _ (_Porphyromonas asaccharolytica_) sensitive to ceftiofur hydrochloride. - For the 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 hydrochloride. The indication is restricted to cases where treatment with another antimicrobial has faile Lugege kogu dokumenti