CEFTIOMAX 50 mg/ml ceftiofur suspension for injection for swine and cattle
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
21-08-2013
Summary of Product characteristics
(SPC)
21-08-2013
Active ingredient:
ceftiofur hydrochloride 50 mg/ml
Available from:
Calier Portugal, S.A.
ATC code:
QJ01DD90
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Ceftiofur
Therapeutic area:
Cattle, Pigs
Authorization date:
2011-04-02
Patient Information leaflet
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
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Summary of Product characteristics
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
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