COBACTAN LA 7.5% suspension for injection for cattle
Kraj: Hiszpania
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
Charakterystyka produktu
(SPC)
22-03-2013
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Składnik aktywny:
cefquinome sulfate 75 mg/ml
Dostępny od:
Intervet
Kod ATC:
QJ01DE90
Forma farmaceutyczna:
Suspension for injection
Grupa terapeutyczna:
Cefquinome
Dziedzina terapeutyczna:
Cattle
Data autoryzacji:
2011-03-11
Charakterystyka produktu
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
COBACTAN LA 7.5% w/v suspension for injection for cattle
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
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bovine respiratory disease (BRD) associated with _Mannheimia haemolytica, _
_Pasteurella multocida and Histophilus somni_ sensitive to cefquinome._ _
4.3
CONTRAINDICATIONS
Do not use in animals which are known to be hypersensitive to cephalosporin antibiotics and other
β-lactam antibiotics.
Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Cobactan 7.5% selects for resistant strains such as bacteria carrying extended spectrum
betalactamases (ESBL) which may constitute a risk to human health if these strains disseminate to
humans e.g. via food. For this reason, Cobactan 7.5% should be reserved for the treatment of clinica l
conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases
when treatment must be initiated without bacteriological diagnosis), to first line treatment. Official,
national and regional antimicrobial policies should be taken into account when the product is used.
Increased use, including use of the product deviating from the instructi
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