HIDROCOL, 4000000 IU/ML SOLUTION FOR USE IN DRINKING WATER/MILK
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
11-08-2016
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Składnik aktywny:
COLISTIN SULFATE
Dostępny od:
SP Veterinaria, S.A.
Kod ATC:
QA07AA10
INN (International Nazwa):
COLISTIN SULFATE
Dawkowanie:
4000000 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:
2016-07-15
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIDROCOL, 4000000 IU/ml solution for use in drinking water/milk
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Colistin (as sulfate)
4000000 IU
Excipients:
Benzyl alcohol
(E1519)
0.010 ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for use in drinking water/milk
A brown –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
Cattle (calves), sheep (lambs), pigs, chickens and turkeys:
Treatment and metaphylaxis of enteric infections caused by non-invasive _E. Coli_, susceptible to colistin.
The presence of the disease should be established in the group or herd before metaphylactic treatment.
4.3 CONTRAINDICATIONS
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.
Do not use in case of hypersensitivity to colistin or to any of the excipients.
Do not use in case of resistance to polymyxins.
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.
As an adjunct to treatment, good management and hygiene practices should be introduced in order to
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