CEMAY 50 mg/ml suspension for injection for pigs
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
ceftiofur hydrochloride 50 mg/ml
Available from:
LABORATORIOS MAYMÓ, S.A.
ATC code:
QJ01DD90
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Ceftiofur
Therapeutic area:
Pigs Food
Authorization date:
2011-06-28
Summary of Product characteristics
CEMA Y – SPC Proposal – May 2011
1/5
1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Cemay, 50
mg/ml, suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as ceftiofur hydrochloride) 50.0 mg
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection.
A white or slightly yellow coloured opaque suspension.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections associated with bacteria sensitive to
ceftiofur:
For the treatment of bacterial respiratory disease associated with _Pasteurella multocida_,
_Actinobacillus pleuropneumoniae _and _Streptococcus suis_.
4.3 CONTRAINDICATIONS
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other
-
lactam antibiotics or to any of the excipients.
Do not inject intravenously.
The product should not be used in the case of known resistance to the ceftiofur or to other
beta-lactam antibiotics.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Shake the bottle well for 30
seconds before use to bring the veterinary medicinal product back
into suspension.
In case of the occurrence of allergic reaction the treatment should be withdrawn.
Inappropriate use of the veterinary medicinal product may increase the prevalence
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