COLICRID 10%

100 mg/ml, oral solution for pigs and chickens (broilers)

Indications

In pigs and chickens (broilers) it is used in the treatment and metaphylaxis of gastrointestinal infections caused by non-invasive E. coli strains sensitive to colistin sulfate. The presence of the disease in the herd should be established before metaphylactic treatment.

COMPOSITION

Colistin sulfate     2.000.000 UI (equivalent to 100 mg/ml)

 

CONTRAINDICATIONS

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

Do not use in horses, particularly in foals, since colistin sulfate, 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.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Pigs: 5 mg (100.000 IU) active substance/kg body weight/day, (0,05 ml product), for 5 consecutive days.

The amount of Colicrid Solution (ACS) will be calculated based on the Total Body Weight (TBW) of the herd to be treated and the Total Water Consumption (TWC) of the herd in 24 hours using the formula:

 

CSC (L) = 5 x GCT (kg) 100 x CAT (L)

per 1000 liters of medicated water in the tank

5 = dose / kg b.w.

100 = mg of colistin sulfate/ 1 ml Colicrid oral solution

 

Chickens (broilers): 3,75 mg (75.000 IU)/ active substance/kg body weight/day, for 5 consecutive days.

The amount of Colicrid Solution (ACS) will be calculated based on the Total Body Weight (TBW) of the herd to be treated and the Total Water Consumption (TWC) of the herd in 24 hours using the formula:

 

CSC (L) = 3,75 x GCT (kg) 100 x CAT (L)

per 1000 liters of medicated water in the tank

3.75 = dose / kg b.w.

100 = mg de colistin sulfate/ 1 ml Colicrid oral solution

 

The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted. In both target species the administration is carried out orally, via the drinking water. To avoid under or over-dosing bodyweight should be determined as accurately as possible. In the case of mass treatment, the animals will be grouped according to their average weight.

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

 

ADVICE ON CORRECT ADMINISTRATION

The product should be diluted before use. Water consumption must be monitored to ensure proper dosing. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the concentration of Colicrid 10% must be adjusted so that the animals assimilate the recommended dose, otherwise another medication must be considered.

 

WITHDRAWAL PERIODS

Meat and offal:

Pigs: 1 day.

Chickens (broilers): 1 day.

Do not 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. Do not refrigerate or freeze. 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.

 

SPECIAL WARNINGS

The product should be diluted before use. Water consumption must be monitored to ensure proper dosing. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the concentration of Colicrid 10% must be adjusted so that the animals assimilate the recommended dose, otherwise another medication must be considered.

Special precautions for use in animals

Do not use colistin sulfate as a substitute for good management practices. Colistin sulfate 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 sulfate, its use should be limited to treatment or treatment and metaphylaxis of diseases and should not be used for prophylaxis. Whenever possible, colistin sulfate 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 sulfate.

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

Colistin may cause irritation. May cause allergies following inhalation, accidental ingestion or accidental skin or eye contact. People with known hypersensitivity to polymyxins or excipients, should avoid contact with the veterinary medicinal product. To avoid exposure during the preparation of the medicated water wear appropriate protective clothing, safety glasses and waterproof gloves. Do not eat, drink or smoke while handling this product. Wash hands after use.

In case of accidental ingestion, wash your mouth immediately with water and seek medical attention. In case of accidental skin contact, wash the area with soap and water. In case of accidental contact with eyes, rinse thoroughly with clean tap water.

If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the physician this warning.

Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.                                

Adverse reactions (frequency and seriousness)

None known.                            

Use during pregnancy, lactation or lay

Laboratory studies in mice and rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Do not use in birds producing eggs for human consumption.

Interaction with other medicinal products and other forms of interaction

Amplifying effects with beta-lactams and bacteriostatics (tetracyclines and macrolides).

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

In case of overdose it may cause gastrointestinal disorders. In this case the medication should be stopped and a symptomatic treatment will be required.

Major incompatibilities

Incompatible with bivalent cations (calcium, magnesium, manganese).

 

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. Medicines should not be disposed of via wastewater or household waste.

 

PRESENTATION/PACKAGE

HDPE white vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml and HDPE canisters of 5 L , 10 L, 20 L.


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