COLISCOUR 2 000 000 IU/ML, CONCENTRATE FOR ORAL SOLUTION, PIGS, POULTRY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-12-2015
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Active ingredient:
COLISTIN
Available from:
Ceva Santé Animale
ATC code:
QA07AA10
INN (International Name):
COLISTIN
Dosage:
2,000,000 IU/ML
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Fowl - Duck, Fowl - Turkey, Porcine
Therapeutic area:
Colistin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2007-09-14
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliscour 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and poultry.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 hypersensitivity to polypeptide antibiotics or to any of the excipients.
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 not recommended.
ACTIVE SUBSTANCE:
Colistin (as sulphate)
2,000,000 IU
EXCIPIENTS:
Benzyl alcohol (E1519)
10 mg
Excipients qs
1 ml
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/11/2015_
_CRN 7022065_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS F
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