TILODEM 50

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ANTIBIOTIC

Tylosin tartrate 500 mg/g.
Water-soluble powder for pigs and chickens

Formula

Each gram of product contains:
Tylosin tartrate (active substance): 500 mg

Pigs and chickens: for both local and systemic action and is a reliable antibiotic for treating the infections produced by penicillin-resistant bacterial strains. It is used for treatment and control of infections caused by tylosin-susceptible bacteria: chronic respiratory disease in chickens, enteritis, bronchopneumonia, metritis, pyoderma, urinary infections, mastitis, arthritis, omphalophlebitis, salpingitis.

Administration

Tilodem 50 is administered via drinking water in the following dosages:

In pigs: 62,5 – 75 mg Tilodem 50/kg body weight/day (equivalent to 25 – 30 mg tylosin/kg), for 4-5 consecutive days.

In chickens: 75 – 100 mg Tilodem 50 /kg body weight/day (equivalent to 30 – 40 mg tylosin/kg) for 4-5 consecutive days.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not give to animals with known hypersensitivity to tylosin or other macrolides.

Side effects

There are no undesirable effects at recommended dosages.

Special precautions for storage

Store in original packaging, at temperature bellow 25^oC, 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. 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.

Withdrawal period

Meat and offal

Pigs: 10 days.

Chickens: 4 days.

Eggs: 4 days.

Special warnings

Due to variability (time, geographical) in susceptibility of bacteria for tylosin, bacteriological sampling and susceptibility testing of microorganisms from diseased animals on farm are highly recommended. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.

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 gloves, goggles and protective dust masks should be worn when handling or mixing the product. 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.

It cannot be associated with antibiotics from the chloramphenicol group (florfenicol, thiamphenicol) or lincosamides (lincomycin, clindamycin). It shows synergism with sulfonamides. It can be associated with preventive anticoccidians, including ionophores.

Overdose can cause gastrointestinal disorders manifested by diarrhea and/or vomiting. Immediately remove the medicated water. The animals are clinically monitored and, if necessary, they intervene with treatment to support vital functions.

Pharmacodynamic incompatibility with beta-lactamides and lincosamides.

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.