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Pigs: treatment and metaphylaxis of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Rabbits: Treatment and metaphylaxis of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Tilmicosin (as phosphate) 200 mg/g
Horses or other Equidae, must not be allowed access to feeds containing tilmicosin. Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death. Do not use in case of hypersensitivity to tilmicosin or to any of the excipients.
In very rare cases, feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient.
The uptake of medicated feed depends on the clinical condition of the animals. In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Use the following formula:
Kg Premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg)
Daily feed intake (kg) x premix strength (g/kg)
Pigs
Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Rabbits
Administer in the feed at 12.5 mg/kg body weight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
To ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20-50 kg) before incorporation into the finished feed.
This product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C.
Pigs: 21 days
Rabbits: 4 days
Store in a dry place. Do not store above 25oC. Protect from direct sunlight.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 months.
Shelf life after incorporation into meal or pelleted feed: 3 months.
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended.
Special precautions to be taken by the person administering the 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. Hypersensitivity to tilmicosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
- To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143. 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.
- Do not handle the product if you are allergic to ingredients in the product.
- 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.
The use during pregnancy, lactation or lay
The safety of tilmicosin has not been established in boars used for breeding purposes.
Interactions with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms of overdose have been seen in pigs fed a ration containing levels of tilmicosin up to 80 mg/kg bodyweight (equivalent to 2000 ppm in the feed or ten times the recommended dose) for 15 days.
Incompatibilities
Not to be incorporated into feeds containing Bentonite.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements. See the environmental properties section.
PET/Al/LDPE (inner layer) bags, closed by thermal welding, containing 100 g, 1 Kg and 5 Kg,
or,
Bleached paper/polyethylene bags, stitched closed, containing 10 Kg, 15 Kg, 20 Kg and 25 Kg.
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