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Tilmicosin phosphate 250 mg/ml.
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ANTIBIOTIC
Tilmicodem 25
Formula
Each ml of product contains:
Tilmicosin phosphate (active substance): 250 mg
Target species
Pigs and chickens.
Indications
Pigs: for treatment 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.
Chickens: for treatment and control of infections caused by susceptible bacteria such as: Mycoplasma spp, Pasteurella multocida, Haemophillus paragalinarum, Streptococcus spp., anaerobes (Clostridium spp.) etc.
Administration
The product is administered via drinking water in following dose:
In pigs: the product is administered via drinking water in dosage of 15 – 20 mg tilmicosin phosphate/kg b.w. corresponding to 0.09 ml Tilmicodem 25/kg b.w./day for 3 – 5 consecutive days.
In chickens: 0.08 ml Tilmicodem 25/kg b.w./day (corresponding to 15 – 20 mg tilmicosin phosphate/kg b.w.) for 3 – 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
- Side effects
- Storage
- Correct administration
- Withdrawal period
- Warnings
- Disposal
- Other information
Contraindications
Do not allow horses and other equines access to drinking water containing Tilmicodem 25.
Do not administer in animals with known hypersensitivity to tilmicosin or other macrolides.
Side effects
There are no undesirable effects at recommended dosages.
Special precautions for storage
Keep away from reach and sight of children!
Store in original packaging, at temperature below 25oC, protected from freeze and direct sunlight.
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.
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
Meat and offal
Pigs: 7days.
Chickens: 13 days.
Not permitted for use in laying birds producing eggs for human consumption.
Special warnings
People with known hypersensitivity to tilmicosin or the excipients of the product should avoid contact with the veterinary medicinal product. To avoid exposure during preparation of the medicated drinking water or handling the product, wear overalls, safety glasses, and impervious gloves. Wash hands after handling the product. In case of accidental exposure, wash any splashes from eyes with water; for skin exposure, wash with soap and water. Avoid contact with eyes. If eye contact occurs wash the eyes with plenty of water.
In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.
The product must not be administered undiluted.
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.
Laboratory studies in rodents have not produced any evidence of teratogenic, fetotoxic or maternotoxic effects. The occurrence of cross-resistance with other macrolides and lincomycin is possible. The product should not be mixed with other drugs.
In pigs when the product is overdosed (1.5 or 2 times more than recommended doses), some animals exhibit a reduced water intake and in extreme circumstances, the dehydration can occur consequently. These cases can be corrected by removing the medicated drinking water and replacement with unmedicated fresh water.
No reduced water intake was observed in chickens. In case of overdosage, in chickens was observed a reduction in faecal consistency.
Special precautions for the disposal of unused product or waste materials
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.
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.
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