Antibiotic

Doxidem 50

Doxycycline hyclate 500 mg/g.
Water-soluble powder for pigs and chickens

Formula

Each gram of product contains:

Doxycycline hyclate (active substance): 500 mg  

Target species

Pigs and chickens.

Indications

Pigs: for treatment of digestive and respiratory infections caused by susceptible strains of bacteria: Escherichia coli, Corynebacterium spp., Erysipelothrix rhusiopatiae, Listeria spp., Streptococcus spp., Actinobacillus spp., Bordetella spp., Francisella spp., Haemophillus spp., Pasteurella spp., Campylobacter spp., Leptospira spp., Actinomyces spp., Fusobacterium spp., Mycoplasma spp., Chlamydia spp., Rickettsia spp.

Chickens: for treatment of digestive and respiratory infections caused by susceptible strains of bacteria: Escherichia coli, Corynebacterium spp., Listeria spp., Streptococcus spp.,  Actinobacillus spp., Bordetella spp., Francisella spp., Haemophillus spp., Pasteurella spp., Campylobacter spp., Borellia spp., Leptospira spp., Actinomyces spp., Fusobacterium spp., Mycoplasma spp., Chlamydia spp., Rickettsia and Anaplasma spp.

Administration

The product is administered via drinking water in the following dosages:

In chickens: the therapeutically dose is 20-40 mg Doxidem 50/kg/body weight/day, administered for 5 consecutive days. These dosages are achieved by an inclusion rate of 200 – 300 g Doxidem 50 per 1000 liters of drinking water, administered for 5 consecutive days.

In pigs: the therapeutically dose is 20-40 mg Doxidem 50/kg/body weight/day, administered for 5 consecutive days.

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For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorization Holder.

Contraindications

Do not use in animals with known hypersensitivity to tetracyclines.

Side effects

In some cases, the animal with severe renal failure could develop adverse reactions characterized by: anorexia, vomit, diarrhea, abdominal colic, painful defecation.

The possible toxic phenomena are due to doxycycline high concentrations in blood and tissues, which occur after the administration of multiple high doses and in low intervals or in case of severe renal failure.

Digestive apparatus: anorexia, vomits, diarrhea, abdominal colic and pancreatitis; administered for long periods of time can produce staphylococcal enteritis or candidosis (oral, intestinal, pulmonary).

Teeth: dental pigmentation, caries and dental enamel hypoplasia in suckling and young off-springs to whose mothers were treated with Doxidem 50 in the latest period of gestation or after birth.

Special precautions for storage

Store in original packaging, at temperature bellow 25oC, protected from moisture and direct sunlight. Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 7 days.

Do not use after expiry date which is stated on the label.

 

Advice on correct administration

During treatment, the animals should drink only medicated water. Medicated drinking water should be freshly prepared every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. Do not administer in milk and milk substitutes. Watering animals from metal waterers will be avoided as much as possible. 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. The use of suitable calibrating weighing equipment is recommended if part packs are used.

Withdrawal period

Meat and offal

Pigs: 10 days.

Chickens: 7 days.

Not permitted for use in laying birds producing eggs for human consumption.

Special warnings

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and dust masks should be worn when administering the product. Wash hands and exposed skin after use.

In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of microorganisms from diseased birds on farm are highly recommended. A high resistance rate of E.coli, isolated from chickens, against tetracyclines has been documented. Therefore the product should be used for the treatment of infections caused by E.coli only after susceptibility testing has been carried out. As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Other information

Bags 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and 25kg.
Not all pack sizes may be marketed.

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