COLICRID 50%

COMPOSITION

Colistin sulphate 500 mg/g

TARGET SPECIES

Pigs and broilers

INDICATIONS

In pigs and chickens (broilers), in the treatment and metaphylaxis of gastrointestinal infections caused by non-invasive E. coli strains susceptible to colistin sulphate. Before the metaphylaxis treatment, the presence of the disease in the population should be established.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to excipients.

Do not use in horses, especially in colts, because colistin, due to alteration of the gastrointestinal microflora balance, could lead to the development of colitis associated with the administration of antimicrobial drugs (colitis X), usually associated with Clostridium difficile, which may be lethal.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

The treatment consists of administering Colicrid powder. 50% orally, individually or in mass (by dissolution in drinking water), for 5 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health.

For mass treatment, in fodder or drinking water, we recommend the correct calculation of the total live weight and the amount of product to be administered, as well as the preparation of premixes, for proper homogenisation.

Suine - Administer a dose of 100,000 IU a.s./kg bw/day, i.e., 10 mg of Colicride powder 50%/kg/bw /day. 

Broilers - Administer a dose of 100,000 IU a.s./kg bw/day, i.e., 10 mg of Colicride powder 50%/kg/bw /day.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The consumption of medicated water depends on the clinical condition of the animals. In order to obtain a correct dose, the colistin concentration should be adjusted accordingly. Carefully calculate the average body weight to be treated and the daily average water intake before each treatment. 

Medicated drinking water should be freshly prepared every day, before each drinking. 

Any quantity of water that is not consumed within 24 hours should be discarded. Medicated water should be the only source of drinking water for the entire duration of the treatment. 

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

The duration of treatment should be limited to the minimum time required to treat the disease.

The duration of treatment should not exceed 7 days.

WITHDRAWAL PERIOD(S)

Pigs

Meat: 3 days

Broilers

Meat: 3 days

Use in poultry laying eggs for human consumption is not authorised.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

Shelf life of the product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days. Shelf-life after dilution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

Colistin exerts a concentration-dependent action against Gram-negative bacteria. Oral administration results in high concentrations in the gastrointestinal tract, i.e., the target site, due to insufficient absorption of the substance. These factors indicate that a longer treatment duration than that indicated under point 4.9 of the SmPC is not recommended, leading to unnecessary exposure.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Do not use colistin as a substitute for good management practices. Colistin is a state-of-the-art human medicine for the treatment of infections caused by certain multi-resistant bacteria. To minimize any potential risk associated with the widespread use of colistin, its use should be restricted to the treatment and metaphylaxis of diseases and should not be used for prophylaxis. Wherever possible, colistin should only be used on the basis of susceptibility testing. Using the product without following the instructions in the SmPC may lead to treatment failure and an increase in the prevalence of colistin-resistant bacteria.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

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 product. Appropriate protection measures should be taken during handling and dosing of the product.

The personnel handling the product must wear goggles, masks and gloves. In case of accidental contact with eyes, wash with plenty of water and soap and seek medical advice immediately, presenting the package leaflet or product label to the physician.

Wash drops splashed on the skin immediately with soap and plenty of water. Do not smoke, drink or eat while handling the product. In the case of accidental ingestion, seek advice from a physician, presenting the package leaflet or product label.

If symptoms occur following exposure, such as rash, seek medical advice immediately and show the package leaflet or the label to your doctor. Swelling of the face/eyes or difficulty breathing are more serious symptoms and require immediate medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Studies in laboratory animals have revealed no embryotoxic or teratogenic potential.

Product safety has not been demonstrated during the gestation and lactation period.

Use of the product during gestation and lactation is done after the risk-benefit ratio has been assessed by a competent veterinarian.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Colistin sulphate is incompatible with bivalent cations (calcium, magnesium, manganese).

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

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

INCOMPATIBILITIES

Colistin sulphate is incompatible with bivalent cations (calcium, magnesium, manganese).

In the absence of compatibility studies, this medicinal product shall not be administered concomitantly with other veterinary medicinal products.

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

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements. The product should not be discharged into water courses due to its danger to fish and other aquatic organisms. The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and SHALL NOT be used for soil fertilisation. 

PRESENTATION/PACKAGE

25g, 50g, 100g, 1kg, 5kg laminated PET foil/low-density polyethylene bags. 10, 25, 50kg laminated PET foil/low-density polyethylene bags.