SOGECOLI 2 000 000 IU/ML CONCENTRATE FOR ORAL SOLUTION FOR CALVES, LAMBS, PIGS, CHICKENS AND TURKEYS
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
14-12-2016
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Aktiv ingrediens:
COLISTIN (AS SULFATE)
Tilgjengelig fra:
Ceva Santé Animale
ATC-kode:
QA07AA10
INN (International Name):
COLISTIN (AS SULFATE)
Dosering :
2000000 IU/ML
Legemiddelform:
Oral Solution
Resept typen:
POM
Terapeutisk gruppe:
Bovine, Fowl - Chicken, Fowl - Turkey, Ovine, Porcine
Terapeutisk område:
Colistin
Indikasjoner:
Antibiotics
Autorisasjon status:
Authorised
Autorisasjon dato:
2016-04-22
Preparatomtale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sogecoli 2 000 000 IU/ml concentrate for oral solution for calves, lambs, pigs, chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ONE ML CONTAINS :
ACTIVE SUBSTANCE:
Colistin (as sulphate)........................................ 2000 000 IU
EXCIPIENTS:
Benzyl alcohol (E1519)…………………………0.01 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear, yellowish to orange solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), sheep (lambs), pigs, chickens and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves - lambs – pigs - chickens – turkeys .:
Treatment and metaphylaxis of gastrointestinal infections caused by non-invasive _E. coli _susceptible to colistin.
The presence of the disease in the herd should be established before metaphylactic treatment.
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to polypeptide antibiotics or to any of the excipients.
Do not use in case of resistance to polymyxins.
Do not use in horses, particularly in foals, since colistin, due to a shift in the gastrointestinal microflora balance could
lead to the development of antimicrobial associated colitis (Colitis X), typically associated with _Clostridium difficile_,
which may be fatal.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Colistin exerts concentration-dependent activity against Gram-negative bacteria. Following oral administration high
concentrations are achieved in the gastrointestinal tract, i.e. the target site, due to the poor absorption of the substance.
These factors indicate that a longer duration of treatment than the one indicated in section 4.9, leading to unnecessary
exposure, is
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