DOXICOL 60%

COMPOSITION

Doxycycline hyclate 600 mg/g

TARGET SPECIES

Pigs and broilers

INDICATIONS

Doxicol 60% oral powder is indicated in the prevention (in populations where the diagnosis has been confirmed) and the treatment of infections produced by doxycycline-susceptible microorganisms.

Broilers - Digestive diseases caused by E. coli (colibacilosis), micoplasmosis caused by Micoplasma spp.

Pigs - Respiratory diseases associated with Actinobacillus pleuropneumoniae (pleuropneumonia), Pasteurella multocida (pasteurellosis), Mycoplasma hyopneumoniae (enzootic pneumonia), Bordetella bronchiseptica (atrophic rhinitis).

CONTRAINDICATIONS

Do not use in case of known sensitivity to doxycycline or other tetracyclines.

Do not use in animals with liver dysfunction.

Do not administer in case of known resistance to tetracyclines.

ADVERSE REACTIONS

Tetracyclines may cause photosensitivity and allergic reactions.

If suspected adverse reactions occur, treatment should be discontinued

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

Administration: oral, in drinking water, individually or in mass. To ensure a proper dose, the exact body weight of animals will be determined to avoid underdosing.

Dosage - Administer a dose of 10 mg active substance/kg live body weight/day, for 5-8 consecutive days. The amount of Doxicol 60% (CD) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the following formula: CD (L) = [TBW (kg)]/[600xTWC (L)] per 1000 L of water in the tank 10 = dose (mg)/kg bw, 600 = mg doxycycline/1 g Doxicol 60% powder. Throughout treatment, animals should consume only medicated water. The consumption of water depends on the clinical condition of the animals. In order to obtain a correct dose, the Doxycycline concentration should be adjusted accordingly. Medicated drinking water should be freshly prepared every 24 hours.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The product should be well diluted and/or homogenised in drinking water to achieve a uniform dispersion of the product. Water consumption should be monitored to ensure adequate dose. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the DOXICOL 60% concentration should be adjusted so that the animals assimilate the recommended dose.

WITHDRAWAL PERIOD(S)

Meat and offal

Broilers: 7 days

Pigs: 7 days

Do not use in poultry laying eggs for human consumption.

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

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

During treatment, sick animals may have a low water intake, and if necessary a review of the treatment will be performed.

SPECIAL PRECAUTIONS FOR USE ON ANIMALS 

The use of the product should be based on the results of susceptibility testing of isolated bacteria from animals. If this is not possible, therapy will be based on epidemiological information on the susceptibility of isolated bacteria from animals. Using the product in violation of the instructions in the SmPC may increase the prevalence of doxycycline resistance and may decrease the effectiveness of antimicrobial treatments in the penicillin group as a result of cross-resistance.

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

Those with known sensitivity to tetracyclines or excipients will avoid contact with the product. 

To avoid exposure during handling, wear suitable protective equipment (overalls, goggles and waterproof gloves). Do not eat, drink or smoke during product handling. Wash hands after use. In case of accidental ingestion, immediately wash mouth with water and seek medical attention. In case of accidental contact with skin, wash the area with water and soap. In case of accidental contact with eyes, rinse abundantly with clean tap water. If irritation occurs on the skin after exposure, you should seek medical attention and show the package leaflet to your doctor. Swelling of the face, lips and eyes or difficulty breathing are severe symptoms and require urgent medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Do not use in pregnant or lactating sows. Do not use in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

In combination with penicillins and quinolones, doxycycline has an antagonistic effect.

The absorption of doxycycline may be reduced if the product is administered with substances containing magnesium, aluminium, zinc, bismuth, bentonite.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Do not exceed the recommended dose.

In case of overdosage, digestive disorders may occur, manifested by vomiting, diarrhoea, cramps, lack of appetite. Treatment with Doxicol 60% will be stopped and symptomatic treatment initiated.

INCOMPATIBILITIES

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.

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

Ask your vet for information on how to dispose of medicines no longer required. 

These measures contribute to environmental protection. 

Treated animals will be kept in shelters throughout the treatment period, and the manure collected will not be used for soil fertilisation.

PRESENTATION/PACKAGE 

1Kg laminated terephthalate polyethylene foil/low-density polyethylene bags.