COLFIVE 5,000,000 IU/ML CONCENTRATE FOR ORAL SOLUTION FOR CALVES, PIGS, LAMBS, CHICKENS AND TURKEYS
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
21-12-2016
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Składnik aktywny:
COLISTIN SULFATE
Dostępny od:
LIVISTO Int'l, S.L.
Kod ATC:
QA07AA10
INN (International Nazwa):
COLISTIN SULFATE
Dawkowanie:
5,000,000 IU/ML
Forma farmaceutyczna:
Oral Solution
Typ recepty:
POM
Grupa terapeutyczna:
Bovine, Fowl - Chicken, Fowl - Turkey, Ovine, Porcine
Dziedzina terapeutyczna:
Colistin
Wskazania:
Antibiotics
Status autoryzacji:
Authorised
Data autoryzacji:
2015-05-01
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colfive 5,000,000 IU/ml concentrate for oral solution for calves, pigs, lambs, chickens and turkeys.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Colistin (sulfate)
5,000,000 IU
EXCIPIENTS:
Benzyl alcohol (E1519)
10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution
Clear orange-brown solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), pigs, sheep (lambs), chickens and turkeys
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves, lambs, pigs, chickens, turkeys:
Treatment and metaphylaxis of entericinfections 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 colistin 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
As an adjunct to treatment, good management and hygiene practices should be introduced in order to reduce the risk of
infection and to control the potential build up of resistance.
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 ind
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