Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Colistin
Andres Pintaluba S.A.
QA07AA10
Colistin
1,200,000 international unit(s)/gram
Premix for medicated feeding stuff
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
colistin
Antibiotics
Authorised
2016-07-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT COLISTIN APSA 1,200,000 IU/g Premix for medicated feeding stuff for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Colistin (as sulfate) 1,200,000 IU For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Premix for medicated feeding stuff Granulated brown powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig (piglet and pig for fattening). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and metaphylaxis of enteric infections caused by non-invasive_ E.coli_ susceptible to colistin. The presence of disease in the herd should be established 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 resistance to polymyxins. 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 indicated in section 4.9, leading to unnecessary exposure, is not recommended. The intake of medicated feed by animals can be altered as a consequence of illness. In case of insufficient intake of feed, animals should be treated parenterally. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Baca dokumen lengkapnya