Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Colistin Sulphate
Divasa - Farmavic S.A
QA07AA10
Colistin Sulphate
Concentrate for oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Pigs, Sheep
Antimicrobial
Authorized
2010-12-08
Revised: June 2015 AN: 00102/2015 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Coliplus 2,000,000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Pigs and Chickens ES: Colistina Divasa 2,000,000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Pigs and Chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 ml: ACTIVE SUBSTANCE: Colistin (as Colistin sulfate) 2 MIU (equivalent to 83.33 mg) EXCIPIENT(S): Benzyl Alcohol (E1519) 10 mg Disodium edetate 0.1 mg Excipients qs 1 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for oral solution for use in drinking water. Clear yellow-brown solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves), sheep (lambs), pigs and chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and metaphylaxis of gastrointestinal infections caused by non-invasive _Escherichia 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 polypeptide antibiotics or to any of the excipients. Do not use in case of resistance to the polymyxin. 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. Revised: June 2015 AN: 00102/2015 Page 2 of 7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use of the product should be based on susceptibility testing and take into account official and local antimicrobials policies. 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 Read the complete document