HIDROCOL, 4000000 IU/ML SOLUTION FOR USE IN DRINKING WATER/MILK
País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Fitxa tècnica
(SPC)
11-08-2016
Alguns documents d’aquest producte actualment no estan disponibles, podeu enviar una sol·licitud al nostre servei d’atenció al client i us ho notificarem tan bon punt puguem obtenir-los.
Enviar sol.licitud.
Enviar sol.licitud.
ingredients actius:
COLISTIN SULFATE
Disponible des:
SP Veterinaria, S.A.
Codi ATC:
QA07AA10
Designació comuna internacional (DCI):
COLISTIN SULFATE
Dosis:
4000000 IU/ML
formulario farmacéutico:
Oral Solution
tipo de receta:
POM
Grupo terapéutico:
Bovine, Fowl - Chicken, Fowl - Turkey, Ovine, Porcine
Área terapéutica:
Colistin
indicaciones terapéuticas:
Antibiotics
Estat d'Autorització:
Authorised
Data d'autorització:
2016-07-15
Fitxa tècnica
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
Llegiu el document complet
