DOXICOL 60%

600 mg/g, water-soluble for use in drinking water for pigs and chickens (broilers)

Indications

Doxicol 60% is used for treatment and metaphylaxis of infections caused by microorganisms sensitive to doxycycline.

Chickens (broilers): treatment of digestive diseases caused by E.coli (colibacillosis) and mycoplasmosis caused by Mycoplasma spp.

Pigs: treatment of respiratory infections caused by Actinobacillus pleuropneumoniae (pleuropneumonia), Pasteurella multocida, Mycoplasma hyopneumoniae (enzootic pneumonia), Bordetella bronchiseptica (atrophic rhinitis).

COMPOSITION

Doxycycline hyclate     600 mg/g

 

CONTRAINDICATIONS

Do not use in cases of known hypersensitivity to doxycycline or other tetracyclines.

Do not use in animals with hepatic disorders.

Do not use in case of known resistance to tetracyclines.

 

ADVERSE REACTIONS

Tetracyclines can cause photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Administration: to be administered orally in drinking water to individuals or to groups.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

 

Dosage: the dose is 10 mg active substance/kg body weight/day, 5-8 consecutive days.

 

The amount of Doxicol 60% (AD) will be calculated based on the Total Body Weight (TBW) of the treated herd and the Total Water Consumption (TWC) of the herd in 24 hours using the formula:

 

CD (Kg) = 10 x GCT (kg) 600 x CAT (L)

per 1000 liters of medicated water in the tank

10 = dose (mg)/ kg b.w.

600 = mg de doxycycline/ 1 g Doxicol 60 % powder                                                                        

 

The medicated water should be the only source of drinking water, throughout the treatment period.

The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dose, the concentration of doxycycline has to be adjusted accordingly. Medicated water must be renewed every 24 hours.

 

ADVICE ON CORRECT ADMINISTRATION

The product must be well diluted and / or homogenized in drinking water in order to achieve a uniform dispersion. Water consumption must be monitored in order to guarantee the 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, otherwise another medication should be considered.

 

WITHDRAWAL PERIODS

Meat and offal:

Chickens (broilers): 7 days.

Pigs: 7 days.

Not for 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.

 

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 into drinking water: 24 hours.

 

SPECIAL WARNINGS

Special warnings for each target species

The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake, a review of treatment will be performed.

Special precautions for use in animals

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of resistant bacteria to doxycycline and may decrease the effectiveness of tetracycline group due to cross-resistance.

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

People with known hypersensitivity to tetracycline or to the excipients should avoid contact with the product.

To avoid exposure while handling the product, wear appropriate protective equipment (overalls, goggles and waterproof gloves).

Do not smoke, eat or drink while handling this product. Wash hands after use.

In  case of accidental ingestion, wash your mouth immediately with water and seek medical advice immediately.

In the event of eye or skin contact, rinse the affected area with plenty of clean water.

If symptoms develop following exposure, such as skin rash, seek medical advice and show this warning to the physician. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

Use during pregnancy, lactation or lay

Do not use in pregnant or in lactation sows.

Do not use in birds producing 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 together with substances containing magnesium, aluminum, zinc, bismuth or bentonite.

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

Do not exceed the recommended dose. In case of overdose digestive disorders may occur manifested by vomiting, diarrhea, cramps and lack of appetite. Treatment with Doxicol 60% will be stopped and appropriate symptomatic treatment will be initiated.

Major incompatibilities

In the absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.

 

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

50 g, 100 g, 1 kg and 5 kg, bags made of polyethylene terephthalate laminate film / aluminum foil / low density polyethylene.


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