Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Colistin
SP Veterinaria, S.A.
QA07AA10
Colistin
4000000 international unit(s)/millilitre
Solution for use in drinking water/milk
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Chickens, Pigs, Sheep, Turkeys
colistin
Antibiotics
Authorised
2016-07-15
Health Products Regulatory Authority 29 July 2021 CRN00CHHX Page 1 of 5 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 Treatment and metaphylaxis of enteric infections caused by non-invasive E. _Coli_, susceptible to colistin. In the case of metaphylaxis, the presence of the disease in the group / flock must be established before the product is used. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to colistin sulfate or to any of the excipients. Do not use in cases of resistance to polymyxins. Do not use in horses, particularly in foals, since colistin sulfate, 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 sulfate 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 reduce the risk of infection and to control the potential build up of resistance. There is cross-resistance between colistin sulf Perskaitykite visą dokumentą