NAM PHUC THINH TRADING CO., LTD

PLUSCOLAN

Composition: Each ml contains: Colistin (sulfate) 5,000,000 IU; excipient q.s 1 ml.

Pharmaceutical form: Oral solution

Target species: Cattle (calves), pigs, sheep (lambs), chickens and turkeys.

Indications: Treatment and metaphylaxis of enteric infections caused by non-invasive E. coli susceptible to colistin. The presence of the disease in the herd should be established before metaphylactic treatment.

Dosage for each species, route(s) and method of administration

To be administered orally. In drinking water/milk use.

Calves, lambs, pigs: 100.000 IU of colistin per kg body weight daily for 3-5 consecutive days in drinking water or milk (replacer) in calves, equivalent to 0.20 ml of the concentrate solution per 10 kg body weight per day for 3-5 days.

Chickens and turkeys: 75 000 IU of colistin per kg body weight daily for 3-5 consecutive days in drinking water, equivalent to 15 ml of the concentrate solution per Ton of body weight per day for 3-5 days.

Duration of treatment should be limited to the minimum time necessary for the treatment of the disease.

Any medicated water which is not consumed within 24 hours should be discarded.

Any medicated milk which is not consumed within 6 hours should be discarded.

Direct oral administration to individual animals: The recommended daily dose should be divided into two if the product is to be administered directly into the mouth of the animal.

Prior to direct oral administration, the product should be diluted with a volume of drinking water equivalent to 2.5 x the volume of product concentrate to be administered.

Administration via drinking water: The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of colistin has to be adjusted accordingly. Carefully calculate the average body weight to be treated and the average daily water consumption before each treatment.

Medicated water should be made every day, immediately prior to provision.

The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period. With the following formula, we can calculate an exact dosage:

... ml of the product/kg B.W./day x average kg B.W. : average daily water intake (L/animal) = ... ml of the product/L of drinking water

Contraindications:

Do not use in case of hypersensitivity to colistin or to any of the excipients.

Do not use in case of resistance to polymyxins.

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.

Adverse reactions: None known. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Overdose: None

Use during pregnancy, lactation or lay: The safety of colistin during pregnancy, lactation or lay was not investigated in target species. However, colistin is poorly absorbed after oral administration, therefore the use of colistin during pregnancy, lactation or lay should not lead to particular problems. Use only accordingly to the benefit-risk assessment by the responsible veterinarian during these periods.

Interaction with other medicinal products and other forms of interaction: After oral administration of colistin sulfate interaction with anaesthetics and myorelaxants may not be excluded in individual cases. The combination with aminoglycosides and levamisole should be avoided. The effects of colistin sulfate may be antagonized by binary cations (iron, calcium, magnesium) and by unsaturated fatty acids and polyphosphates. There is cross-resistance between colistin and polymyxin B.

Withdrawal period:

Calves, lambs and pigs: Meat and offal: 1 day.

Chickens and turkeys: Meat and offal: 1 day; Eggs: Zero days.

Storage conditions: This veterinary medicinal product does not require any special storage conditions. Once opened, use within 3 months. Once reconstituted in water, use within 24 hours. Once reconstituted in milk, use within 6 hours.

Presentations: Bottles of 100 ml; 1 and 5 l.

Shelf-life: 2 years from the manufacturing date.

FOR VETERINARY USE ONLY

Keep out of the reach of children

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain