TILODEM 10%

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ANTIBIOTIC

Tylosin tartrate 100 mg/g.
Premix for medicated feed for pigs and chickens

Formula

Each gram of product contains:
Tylosin tartrate (active substance): 100 mg

In pigs and chickens: for treatment of primary or secondary, local or systemic diseases produced by bacteria susceptible to the action of the active substance: enzootic swine pneumonia, enteritis, bronchopneumonia, metritis, pyoderma, urinary infections, mastitis, arthritis, omphalophlebitis, salpingitis, chronic respiratory diseases.

Administration

The product is administered orally, in feed, as follows:

In chickens: it is administered orally, in a dose of 80-100 mg TILODEM 10%/kg/body weight/ twice per day, for 4-5 consecutive days.

In chickens up to 14 days old: 1000 g product / 1000 kg of feed, for 4-5 consecutive days.

In chickens over 14 days old and adults: 800 g product / 1000 kg of feed, for 4-5 consecutive days.

In pigs: it is administered orally, in a dose of 100 mg TILODEM 10%/kg b.w/twice per day, for 4-7 consecutive days.

In pigs up 70 days old: 1000g product/1000kg feed, for 4-5 consecutive days.

In pigs over 70 days old and adults: 800 g product /1000 kg of feed, for 4-5 consecutive days.

The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed or drinking water may have to be adjusted.

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 excipient.

Side effects

None.

Special precautions for storage

Keep away from reach and sight of children.

Keep in original packaging, at temperature below 25^oC, protected from direct sunlight and moisture.

Shelf-life after first opening of primary package: 28 days.

Shelf life after incorporation into meal or pelleted feed: 7 days

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

Advice on correct administration

During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The product should be well mixed with the feed to be homogenous.

Withdrawal period

Meat and offal:

Pigs, chickens: 28 days.

Eggs: 7 days.

Special warnings

The use of the product will be based on susceptibility tests of bacteria isolated from animals. If this is not possible, therapy will be based on epidemiological information on the susceptibility of bacteria isolated from animals. National and regional antimicrobial policies should be taken into account when using the product. Use of the product deviating from the instructions given in the SPC may lead to treatment failures and increase the prevalence of bacteria resistant to tylosin or other macrolides due to the potential of cross-resistance. In the European strains of Brachyspira hyodysenteriae, a high rate of in vitro resistance was demonstrated, which suggests that the product will not be sufficiently effective 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 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.

The safety of the product has not been demonstrated during pregnancy and lactation. The use of the product during pregnancy and lactation will be done only after the evaluation of the benefit/risk balance by the veterinarian.

Overdose can cause gastrointestinal disorders manifested by diarrhea and/or vomiting. Immediately remove the medicated feed. If signs of intoxication do occur promptly remove the medicated feed, replace with fresh un-medicated feed and apply supportive, symptomatic therapy

It will not be associated with antibiotics from the chloramphenicol group (florfenicol, thiamphenicol) or lincosamides (lincomycin, clindamycin).

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.