ANTIBIOTIC

Tilmicodem 25

tilmicosin phosphate 250 mg/ml, oral solution for pigs and poultry.

Formula

Each ml of TILMICODEM 25 contains:

Active substance

Tilmicosin phosphate 250 mg

electuary

Propyl gallate 0.2 mg

Target species

Pigs and poultry

Indications

In pigs: for treatment and control of respiratory infections associated with Mycoplasma hyopneumoniae, Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Bordetella bronchisep- tica and also for other infections produced by tilmicosin susceptible bacteria such as: Fusobacterium spp., Erysipelothrix rhusiopatiae, Listeria, Clostridium spp. etc.
In poultry: for treatment of infections produced by susceptible bac- teria such as: Mycoplasma spp, Pasteurella multocida, Haemophillus paragalinarum, Streptococcus spp., anaerobs (Clostridium spp.) etc.

Administration

In pigs: the product is administered via drinking water in dosage of 15 – 20 mg tilmicosin/kg (equivalent to 17 – 22 mg tilmicosin phosphate/ kg b.w.) corresponding to 0.07 – 0.09 ml Tilmicodem 25/kg b.w./day for 3 – 5 consecutive days
In poultry: the product is administered via drinking water in dos-
age of 15 – 20 mg tilmicosin/kg (equivalent to 17 – 22 mg tilmicosin phosphate/kg b.w.) corresponding to 0.07 – 0.09 ml Tilmicodem 25/kg b.w./day for 3 – 5 consecutive days.

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.

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

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Contraindications

Do not allow horses and other equines access to drinking water con- taining Tilmicodem 25.

Side effects

There are no undesirable effects 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 bellow 25°C, protected from direct sunlight and moisture. Protect from freezing. 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: 28 days. Close tight the recipient after every use. Do not use after expiry date which is stated on the label.

Advice on correct administration

The product must be diluted before administration to the animals. During treatment, the animals should drink only medicated water. Medicated drinking water should be prepared fresh every 24 hours. To ensure a correct dosage, body weight should be determined as ac- curately as possible to avoid underdosing.

Withdrawal period

Edible tissues of pig: 7days from cessation of oral medication. Edible tissues of poultry: 12 days from cessation of oral medication. Not per- mitted for use in laying bird 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. Persons involved in the drug administration should wear special protection equipment (mask, eye protectors and rubber gloves). The direct con- tact of persons with Tilmicodem 25 solution should be avoided, first of all concerning eyes, skin and clothing. In case of accidental exposure, wash any splashes from eyes with water; for skin exposure, wash with soap and water. Wash hands and exposed skin after use. In case of acci- dental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention. The use of the product should be based on suscepti- bility 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.

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 prod- ucts should be disposed of in accordance with local requirements.

Other information

PE-HD flasks of 100 ml, 500 ml, and 1000 ml.
PE-HD cans of 5 l, 10 l, and 20 l.
Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.