COLIDEM 50

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ANTIBIOTIC

Colistin sulphate 500 mg/g.
Water-soluble powder for pigs and chickens

Formula

Each gram of product contains:

Colistin sulphate (active substance): 500 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

During treatment, the animals should drink only medicated water. Medicated drinking water should be freshly prepared every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

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

Store in original packaging, at temperature bellow 25^oC, protected from moisture and direct sunlight. Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 7 days.

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

Advice on correct administration

Withdrawal period

Meat and offal

Pigs, chickens: 3 days.
Eggs: 1 day.

Special warnings

Special precautions for use in animals

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 minimize 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.

Special precautions to be taken by the person administering the medicinal product to animals

People with known hypersensitivity to any of the product ingredients 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. Wash hands and exposed skin after use. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. 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.