CEFTIOCYL 50 MG/ML, SUSPENSION FOR INJECTION FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-12-2015
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Active ingredient:
CEFTIOFUR
Available from:
Vetoquinol UK Limited
ATC code:
QJ01DD90
INN (International Name):
CEFTIOFUR
Dosage:
50 Mg/Ml
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Ceftiofur
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2010-09-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Ceftiofur (as hydrochloride) 50.0 mg
Excipients
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Slightly yellow to slightly pink, milky suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
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 _Pasteurella haemolytica _(_Mannheimia _spp.),
_Pasteurella multocida _and _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.
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 antibiotics.
Do not use in case of known resistance to the active substance.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to human.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Accidental injection is dangerous.
HEALTH PRODUC
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