COLICRID PULV. 50%

COMPOSITION

Colistin sulfate       500 mg/g

CONTRAINDICATIONS

Do not use in case of hypersensitivity to colistin 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.

Do not use in rabbits.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Colicrid pulv.50% is administered orally, to individuals or to the mass (by incorporating it into drinking water), for 5 consecutive days, in different dosages, according to the species, age, weight, physiological status and health. For the mass treatment, in drinking water, we recommend the correct calculation of the total weight and the product quantity that must be administered, as well as the preparation of premixes, for a correct homogeneity.

Ø Pigs: the recommended dosage is 100.000 UI a.s./kg b.w./day, equivalent to 10 mg Colicrid pulv.50% / kg /b.w. /day.

Ø Chickens (broilers): the recommended dosage is 100.000 UI a.s./kg b.w./day, equivalent to 10 mg Colicrid pulv.50% / kg /b.w. /day.

The duration of treatment should be limited to the minimum time necessary to treat the disease. The duration of treatment should not exceed 7 days.

ADVICE ON CORRECT ADMINISTRATION

The uptake of medicated water depends on the physiological and clinical conditions of the animals. In order to obtain the correct dosage the concentration of colistin has to be adjusted accordingly. To ensure a correct dosage, body weight and the daily water consumption should be determined before each treatment.
Medicated drinking water must be freshly prepared, every day, before each drinking. Any amount of water with product that is not consumed within 24 hours should be discarded. The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIODS

Meat and offal:

Pigs: 3 days.

Chickens (broilers): 3 days.

Not for use in birds producing eggs for human consumption.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package. Store in a dry place. Protect from direct sunlight.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

SHELF-LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

Shelf life after reconstitution into drinking water: 24 h.

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 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 in the SPC may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.

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

The product may cause irritation of the respiratory tract, skin and eyes in case of inhalation or contact. Avoid direct contact with skin and eyes while handling the medicinal product. Special precaution should be taken when handling and dosing the product.

Use personal protective equipment consisting of gloves, mask, goggles while handling the product. In case of eye contact, rinse the affected area with plenty of water and soap and seek medical advice.

Do not smoke, eat or drink while handling this product.

In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.                           

If symptoms such as rash appear after exposure, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or respiratory difficulties are the most serious signs which require urgent medical attention.              

Use during pregnancy, lactation or lay

Laboratory studies have not produced any evidence of embryotoxic or teratogenic effects.

The safety of colistin during pregnancy, lactation or lay was not investigated in target species. 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

Colistin sulfate is not compatible with bivalent cations such as calcium, magnesium and manganese. 

Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdose can cause gastrointestinal effects. In this case it is necessary to stop the medication and introduce symptomatic treatment.

Major incompatibilities

Colistin sulfate is not compatible with bivalent cations such as calcium, magnesium and  manganese.

In the absence of compatibility studies, this product should not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Veterinary medicinal product must not be disposed of via wastewater or the drainage systems.  The treated animals are kept in shelters throughout the treatment period, and the resulting manure will Not be used to fertilize the soil.

PRESENTATION/PACKAGE

50 g, 100 g, 500 g, 1 kg, 5 kg, bags made of laminated foil/ low density polyethylene.

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