TILMICODEM 25

Oral Solution

Oral solution for pigs and poultry.

Manufacturing Authorisation Holder: S.C. Delos Impex ’96 S.R.L., 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania

Tel. +0040-372 714 433 Fax: +0040-0372 871 445

NAME OF THE VETERINARY MEDICINAL PRODUCT: TILMICODEM 25, as tilmicosin phosphate 250 mg/ml, oral solution for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS: 1 ml solution contains: Tilmicosin phosphate: 250 mg (equivalent to 225 mg tilmicosin base). , Excipients (propyl gallate, disodium edentate, orthophosphoric acid, puriffied water) ad. 1 ml.

INDICATIONS

In pigs: for treatment and control of respiratory infections associated with Mycoplasma hyopneumoniae, Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Bordetella bronchiseptica 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 bacteria such as: Mycoplasma spp, Pasteurella multocida, Haemophillus paragalinarum, Streptococcus spp.,anaerobs(Clostridium spp.) etc.

CONTRAINDICATIONS: Do not allow horses and other equines access to drinking water containing Tilmicodem 25.

ADVERSE REACTIONS: There are no undesirable effects at recommended dosages.

TARGET SPECIES: Pigs and poultry.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF 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 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. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Tilmicodem 25 should be calculated according to the following formula:

Tilmicodem 25

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.

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 accurately as possible to avoid underdosing.
WITHDRAWAL PERIOD: Edible tissues of pig: 7days from cessation of oral medication. Edible tissues of poultry: 13 days from cessation of oral medication. Not permitted for use in laying bird producing eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE: Keep away from reach and sight of children! Store in original packaging, at room temperature (15–25°C), 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: 28 days. Close tight the recipient after use. Do not use after expiry date which is stated on the label.
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 contact 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 accidental 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 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.

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.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

February 2012

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.