Indications
Doxicol 60% oral powder is indicated for the treatment and metaphylaxis of infections caused by microorganisms sensitive to doxycycline.
In broilers: digestive diseases caused by E.coli (colibacillosis), mycoplasmosis caused by Mycoplasma spp.
In pigs: respiratory diseases associated with Actinobacillus pleuropneumoniae (pleuropneumonia), Pasteurella multocida (pasteurellosis), Mycoplasma hyopneumoniae (enzootic pneumonia), Bordetella bronchiseptica (atrophic rhinitis).
COMPOSITION
Doxycycline hyclate ……….. 600 mg/g
CONTRAINDICATIONS
Do not use in case of known sensitivity to doxycycline or other tetracyclines.
Do not use in animals with liver dysfunction.
Do not use 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, ROUTE AND METHOD OF ADMINISTRATION
Administration: orally, in drinking water, individually or by mass.
To ensure an appropriate dosage, the body weight of the animals will be determined as accurately as possible to avoid underdosing.
Dosage: a dose of 10 mg active substance/kg live weight/day must be ensured, for 5-8 consecutive days.
The amount of Doxicol 60% (CD) will be calculated based on the Total Body Weight (GCT) of the livestock to be treated and the Total Water Consumption (CAT) of the livestock in 24 hours using the formula:
CD (Kg) =
10 x GCT (kg)
600 x CAT (L)
per 1000 liters of medicated water from the tank
10 = dose (mg) / kg g.v.
600 = mg doxycycline / 1 g Doxicol 60% powder.
During the entire treatment period, the animals must consume only medicated water. Water consumption depends on the clinical condition of the animals. In order to obtain a correct dosage, the concentration of doxycycline must be adjusted accordingly. The medicated drinking water must be freshly prepared every 24 hours.
RECOMMENDATIONS FOR CORRECT ADMINISTRATION
The product must be well diluted and/or homogenized in the drinking water in order to achieve its most uniform dispersion. Water consumption must be monitored in order to guarantee the appropriate dosage. If water consumption does not correspond to the quantities for which the recommended concentrations were calculated, the concentration of Doxicol 60% must be adapted so that the animals assimilate the recommended dose, otherwise another medication must be considered.
WITHDRAWAL TIMES
Meat and offal:
Broilers: 7 days
Pigs: 7 days
Not for use in birds producing eggs for human consumption.
SPECIAL STORAGE PRECAUTIONS
Keep out of reach of children. Do not store above 25ºC. Do not refrigerate or freeze. Store in the original packaging. Protect from light. Store in a dry place. Protect from direct light. Do not use after the expiry date stated on the label.
SHELF LIFE
Shelf life of the product as packaged for sale: 2 years.
Shelf life after first opening the original packaging: 28 days.
Shelf life after reconstitution in drinking water: 24 hours.
SPECIAL WARNINGS
Special precautions for each target species
During treatment, sick animals may have a reduced appetite for water and if necessary, a review of the treatment will be made.
Special precautions for use in animals
The use of the product will be carried out on the basis of susceptibility tests of bacteria isolated from animals. If this is not possible, therapy will be based on epidemiological information regarding the susceptibility of bacteria isolated from animals. Use of the product outside the instructions in the SPC may lead to an increase in the prevalence of resistance to doxycycline and may lead to a decrease in the effectiveness of treatments with antimicrobials from the tetracycline group as a result of cross-resistance.
Special precautions for personnel administering the product
People known to be sensitive to tetracyclines or excipients should avoid contact with the product. To avoid exposure during handling of the product, appropriate protective equipment (overalls, goggles and impervious gloves) should be worn. Do not eat, drink or smoke while handling the product. Wash hands after use. In case of accidental ingestion, rinse 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 eye contact, rinse thoroughly with clean tap water. If skin irritation occurs following exposure, seek medical advice and show the package leaflet to the physician. Swelling of the face, lips and eyes or difficulty breathing are serious symptoms and require emergency medical attention.
Use during pregnancy, lactation or lay
Do not use in pregnant or lactating sows.
Do not use in birds producing eggs for human consumption.
Interactions with other medicinal products and other forms of interaction
Doxycycline has an antagonistic effect in combination with penicillins and quinolones.
The absorption of doxycycline may be reduced if the product is administered together with substances containing magnesium, aluminium, zinc, bismuth, bentonite.
Overdose
Do not exceed the recommended dose. In case of overdose, digestive disorders may occur manifested by vomiting, diarrhoea, colic, lack of appetite. Treatment with Doxicol 60% will be stopped and symptomatic treatment will be instituted.
Incompatibilities
This veterinary medicinal product must not be mixed with other veterinary medicinal products.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements. Medicines should not be thrown away via wastewater or household waste. Ask your veterinarian for information on how to dispose of medicines no longer required. These measures will help protect the environment. Treated animals will be kept in shelters throughout the treatment period and the collected manure will not be used for soil fertilization.
PRESENTATION/PACKAGING
Polyethylene terephthalate/low density polyethylene laminated foil bag x 50 g
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