TILODEM

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ANTIBIOTIC

Tylosin tartrate 200 mg/ml.
Oral solution for pigs, chickens and turkey

Formula

Each ml of product contains:
Tylosin tartrate (active substance): 200 mg

Pigs: for treatment Enzootic Pneumonia, associated with Mycoplasma hyopneumoniae, arthritis produced by Mycoplasma hyosinoviae, bacterial infections produced by tylosin susceptible strains of Pasteurella multocida, Haemophilus suis, Actinobacillus pleuropneumoniae.

Chickens, turkey: for treatment of bacterial infections produced by tylosin susceptible strains: Mycoplasma gallisepticum, Mycoplasma synoviae (avian mycoplasmosis), Clostridium spp. (Necrotic enteritis), Pasteurella multocida (avian cholera), Staphylococcus spp,

Administration

In pigs, Tilodem is administered via drinking water, in dose of 0.20 ml/kg bw (equivalent with 40 mg tylosin tartrate/kg bw)/day for 5 consecutive days.

In chickens, turkeys, Tilodem is administered via drinking water, in dose of 0.35 ml/kg bw (equivalent with 70 mg tylosin tartrate/kg bw)/day for 5 consecutive days.

The uptake of medicated water is dependent on the clinical condition of animals. In order to obtain the correct dosage, the concentration in 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 any excipients of the product.

Side effects

None at recommended dosages.

Special precautions for storage

Keep away from reach and sight of children!

The product should be stored in original packaging at temperature below 25^oC, protected from direct sunlight and frost.

Advice on correct administration

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

Withdrawal period

Pigs (meat and offal): 7 days.
Chickens, turkeys (meat and offal): 5 days.
Eggs: 4 days.

Special warnings

Special warnings for each target species

During the treatment, animals should drink only medicated water. Medicated drinking water should be prepared fresh every 24 hours.

Special precautions for use in animals

Use of the product should be based on susceptibility testing of the bacteria isolated from animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Official, national and regional antimicrobial policies should be taken into account when the

product is used. Use of the product deviating from the instructions given by the SPC may increase the prevalence of bacteria resistant to the tylosin and may decrease the effectiveness of treatment with other macrolides due to the potential for cross resistance.

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

People with known hypersensitivity to tylosin or excipients should avoid contact with the veterinary medicinal product. To prevent any unwanted effects, persons involved in the drug administration should wear special protection equipment (mask, eye protectors and rubber gloves).

Wash hands and exposed skin after use. In case of accidental ingestion or accidental exposure of the skin wash with water seek medical advice. The occurrence of symptoms characterized by skin rash, swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Use during pregnancy, lactation and laying periods

Laboratory studies in laboratory animals have not produced any evidence of teratogenic, fetotoxic or maternotoxic effects.

Interactions with other medicinal products

The product cannot be associated with amphenicols (florfenicol, thiamphenicol) or lincosamides (lyncomicin).The product has synergic effect with sulphamides and tetracycilines (doxycycline).

Incompatibilities

The product should not be mixed with other drugs.

Overdose (symptoms, emergency procedures, antidotes)

In turkey in case of overdose (3 times more than recommended doses), some birds could exhibit a reduced water intake.

In pigs in case of overdose (5 times more than recommended doses), some animals could exhibit a reduced water intake. These cases can be corrected by removing the medicated drinking water and replacement with unmedicated fresh water.

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.