COLIDEM 10%

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ANTIBIOTIC PREMIX

Colistin sulphate 100 mg/g.
Premix for medicated feed for pigs and chickens

Formula

Each gram of product contains:

Colistin sulphate (active substance): 100 mg

In pigs and chickens: for 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.

Administration

In pigs: it is administered orally, in a dose of 12-14 mg Colidem 10% /kg body weight, for 3-5 consecutive days.

In piglets up to 70 days old: 240g of Colidem 10% /1000 kg of feed, for 3-5 consecutive days.

For pigs over 70 days old: 200g of Colidem 10% / 1000 kg of feed, for 3-5 consecutive days.

In chickens: it is administered orally, in a dose of 10-12 mg Colidem 10% /Kg body weight, for 3-5 consecutive days.

In chickens up to 14 days old: 240g of Colidem 10% / 1000 kg of feed, for 3-5 consecutive days.

For chickens over 14 days old: 200g of Colidem 10% / 1000 kg of feed, for 3-5 consecutive days.

Duration of treatment should be limited to the minimum time necessary for the treatment of the disease. The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients.

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.

Side effects

None.

Special precautions for storage

Keep away from reach and sight of children.

Keep in original packaging, at temperature below 25^oC, protected from direct sunlight and moisture.

Shelf-life after first opening of primary package: 28 days.

Shelf life after incorporation into meal or pelleted feed: 7 days

Do not use after expiry date which is stated on the label.

Advice on correct administration

During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The product should be well mixed with the feed to be homogenous.

Withdrawal period

Meat and offal:

Pigs, chickens: 28 days.

Eggs: 7 days.

Special warnings

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, leading to unnecessary exposure, is not recommended.

Do not use colistin as a substitute for good management practices. Colistin is a last resort drug in human medicine for treatment of infections caused by certain multi-drug resistant bacteria. In order to minimise any potential risk associated with widespread use of colistin, its use should be limited to treatment or treatment and metaphylaxis of diseases, and should not be used for prophylaxis. Whenever possible, colistin should only be used based on susceptibility testing. Use of the product deviating from the instructions given may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.

People with known hypersensitivity to colistin should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and dust masks should be worn when administering the product. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.