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Chickens (broilers)
For the treatment of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Pigs
For the treatment of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida and Actinobacillus pleuropneumoniae.
Active substance:
Tilmicosin (as phosphate) 250 mg/ml
Excipients:
Propyl gallate 0.2 mg/ml
Disodium edetate 2 mg/ml
Do not use in horses and other equines.
Do not use in case of hypersensitivity to tilmicosin or to any of the excipients.
In very rare cases, a decrease in water intake has been observed.
If you notice any side effects, even those not already listed in this package leaflet, please contact your veterinarian.
Oral administration via drinking water.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing or overdosing.
Pigs: provide a daily dose of 15-20 mg/kg active substance/ bodyweight for 5 consecutive days.
The amount of the TYLOPLUS 25% solution (ATS) can be calculated based on the Total Body Weight of pigs to be treated (TBW) and the Total Water Consumption of the pigs per 24 hours (TWC) with the following formula:
ꭓ = dose / kg b.w.
250 = mg de tilmicosin/ 1 ml Tyloplus 25% oral solution
Chickens (broilers): provide a daily dose of 15-20 mg/kg active substance/ bodyweight for 3 consecutive days.
The amount of the TYLOPLUS 25% solution (ATS) can be calculated based on the Total Body Weight of chickens to be treated (TBW) and the Total Water Consumption of the chickens per 24 hours (TWC) with the following formula:
ꭓ = dose / kg b.w.
250 = mg de tilmicosin/ 1 ml Tyloplus 25% oral solution
The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of tilmicosin should be adjusted accordingly.
The product must be diluted before administration to animals.
Water consumption should be monitored in order to guarantee adequate dosing. In case water consumption does not match quantities for which recommended concentrations were calculated, the concentration of TYLOPLUS 25% has to be adapted in a way that the recommended dosage will be taken up by the animals, otherwise different medication should be considered.
Meat and offal:
Chickens (broilers): 12 days.
Pigs: 14 days.
Not authorised for use in laying birds producing eggs for human consumption.
Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.
Shelf-life after first opening the immediate packaging: 28 days.
Shelf-life after reconstitution in drinking water: 24 hours.
Special warnings for each target species
The product must be diluted before administration to animals.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the isolated bacteria.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance.
Medicated drinking water uptake can be affected by the severity of the disease. In case of insufficient water intake, animals should be treated parenterally. In case of insufficient water intake, the treatment should be revised. Medicated drinking water should be prepared fresh every 24 hours.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Tilmicosin may induce irritation. Macrolides, such as tilmicosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. People with known hypersensitivity to the active substance or excipients should avoid contact with the veterinary medicinal product. Allergic reactions to tilmicosin may be serious.
To avoid exposure during preparation of the medicated drinking water, personal protective equipment consisting of overalls, safety glasses and impervious gloves should be used. Do not eat, drink or smoke when handling this product. Wash hands after use.
In the case of accidental ingestion, wash out mouth immediately with water and seek medical advice. In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water.
If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Use during pregnancy, lactation or lay
The safety of tilmicosin has not been established during breeding purpose, pregnancy and lactation in animals, therefore use accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicaments and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In pigs in case of overdosing, commonly animals exhibit a reduced water intake, that it could, in extreme circumstances, result in dehydration. This can be corrected by the removal of the medicated drinking water and replacement with fresh unmedicated water.
No symptoms of overdose have been seen in chickens given drinking water containing levels of tilmicosin of 5 times the recommended dose.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
HDPE vials containing 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml closed with a HDPE screw cap.
HDPE canister containing 5L, 10L, 20L closed with a HDPE screw cap.
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