CLORCRID 40% PREMIX

COMPOSITION

Hydrochloric chlortetracycline 400 mg/g.

TARGET SPECIES

Pigs and broilers.

INDICATIONS

Pigs - For the treatment of respiratory infections caused by A. pleuropneumoniae susceptible to chlortetracycline hydrochloride.

Broilers - In the treatment of digestive infections caused by E coli strains susceptible to chlortetracycline hydrochloride.

CONTRAINDICATIONS

Do not use in animals with known hypersensitivity to tetracyclines or to any of the excipients.

 Do not use in animals with renal deficiencies. Do not administer in animals with known resistance to tetracyclines.

ADVERSE REACTIONS

None known.

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

The treatment consists of oral administration of CLORCRID 40% in fodder, individually or in mass, for 5-7 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. 

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing. For mass treatment, the animals should be grouped according to body weight and should be dosed appropriately to avoid underdosing. To ensure good homogenisation of the product, it must first be mixed with a suitable amount of fodder to obtain a premix before it is incorporated into the final fodder.

Pigs Administer a dose of 20-40 mg active substance/kg body weight/day, equivalent to 50-100 mg of CLORCRID 40%/kg of body weight/day. 

Broilers Administer a dose of 20-40 mg active substance/kg body weight/day, equivalent to 50-100 mg of CLORCRID 40%/kg of body weight/day.  

Throughout treatment, animals should consume only medicated fodder.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Fodder consumption should be monitored to ensure adequate dose. 

If the fodder consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the CLORCRID 40% concentration should be adjusted so that the animals assimilate the recommended dose. Otherwise another medication should be considered.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 7 days

Broilers - Meat and offal: 3 days

Eggs from poultry treated with Clorcrid 40% premix are not intended for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Keep 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 veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days. Shelf-life after incorporation into fodder: 28 days.

SPECIAL PRECAUTIONS FOR USE ON ANIMALS 

The use of the product should be based on the results of susceptibility testing of isolated bacteria. If this is not possible, therapy will be based on epidemiological information on the susceptibility of isolated bacteria.

Using the product in violation of the instructions in the SmPC may increase the prevalence of clortetracycline resistance and may decrease the effectiveness of antimicrobial treatments in the tetracycline group as a result of cross-resistance. National and regional antimicrobial policies shall be observed when using the product.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT

Those with known hypersensitivity to any of the product components should avoid any contact with the product.

Tetracyclines may cause hypersensitivity (allergy) after, inhalation, ingestion or skin contact. 

Allergic reactions to these substances may be severe. 

Appropriate protection measures should be taken during product incorporation into fodder. 

Specialised personnel must wear goggles and masks. 

In case of contact with eyes, rinse with plenty of water. 

In case of post-exposure symptoms, such as rash, seek medical advice and show the package leaflet to the doctor.

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

Do not eat, drink or smoke during product handling. 

Wash hands after use.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Chlortetracycline crosses the placental barrier and can cause abnormal colouration of the bones and teeth in the foetus. Chlortetracycline is partially eliminated through milk. Product safety has not been demonstrated during the gestation and lactation period. Product can be administered during gestation and lactation after the risk-benefit ratio has been assessed by a veterinarian. Do not use in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

The bivalent or trivalent cations (Mg, Fe, Al, Ca) can chelate tetracyclines. Tetracyclines should not be administered with antacids, aluminium-based gels, mineral-based preparations, because insoluble complexes are formed that reduce antibiotic absorption.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Chlortetracycline has a low toxicity and its administration is very safe if the recommended dose is used. On rare occasions overdose can cause diarrhoea.

INCOMPATIBILITIES

In the absence of compatibility studies, this veterinary medicinal product shall not be mixed 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 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. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

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

25 kg, 50 kg laminated terephthalate polyethylene foil/aluminium/low-density polyethylene bags sealed by heat-sealing.