Cobactan LA 7,5% suspensie voor injectie voor varkens
Țară: Țările de Jos
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
Caracteristicilor produsului
(SPC)
20-09-2013
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Trimite cerere.
Trimite cerere.
Ingredient activ:
cefquinome 75 mg/ml
Disponibil de la:
Intervet Deutschland GmbH
Codul ATC:
QJ01DE90
Forma farmaceutică:
Suspension for injection
Grupul Terapeutică:
Cefquinome
Zonă Terapeutică:
Pigs Food
Data de autorizare:
2012-03-21
Caracteristicilor produsului
Page 1 of 6
_[TEM-006 Version 01/2006] _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cobactan LA 7.5% w/v suspension for injection for swine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Cefquinome (as sulfate)
75 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
White to off-white resuspendable suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of swine respiratory disease (SRD) associated with _Actinobacillus _
_pleuropneumoniae, Haemophilus parasuis _and _Pasteurella multocida_ sensitive to cefquinome.
4.3
CONTRAINDICATIONS
Do not use in animals which are known to be hypersensitive to cephalosporin antibiotics or to other β-
lactam antibiotics, or to any of the excipients.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
4.4
SPECIAL WARNINGS
In food borne pathogens, co-resistance can occur for various antimicrobial substances including
aminoglycosides, sulphonamides and trimethoprim compounds, chloramphenicol, ciprofloxacin,
gentamycin and tetracycline.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Cobactan LA 7.5% w/v suspension for injection for swine selects for resistant strains such as bacteria
carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these
strains disseminate to humans e.g. via food. For this reason, Cobactan LA 7.5% w/v suspension for
injection for swine s
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