Each g contains 100 mg of Tilmicosin.

A brown granulated powder.

Pigs (weaned piglets and fattening pigs).

Tilmovet 100 mg/g Granules is indicated for the treatment of pneumonia in weaned fattening pigs, caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida sensitive to tilmicosin.

Do not use in animals hypersensitive to tilmicosin and when there is resistance to tilmicosin or cross resistance to other macrolides like tylosin, erythromycin or lincomycin.

Tilmicosin is known to be toxic for horses. Do not allow horses or other equines access to feeds containing tilmicosin.

If for an individual animal, feed intake is such that the recommended dosage is not realized, medication should be carried out by parenteral treatment.

Cross-resistance between tilmicosin and other macrolide antibiotic has been observed. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Due to likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended. 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.

Accidental ingestion should be avoided by humans. People with known hypersensitivity to macrolide antibiotics should avoid contact with the veterinary medicinal product. May cause sensitisation by skin contact. May cause skin and eye irritation. Avoid direct skin contact. Wear overalls, safety glasses and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. In case of accidental ingestion, or if you develop symptoms following exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. If the operations involve the risk of exposure to dust, wear either a disposable filter and half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 fitted with a filter to EN143. This warning is particularly relevant to on-farm mixing, where the risk of exposure to dust is likely to be enhanced.

Occasionally, feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient.

In case of occurrence of allergic reaction, the treatment should be withdrawn.

Laboratory studies in rats have not produced any evidence of a teratogenic, foetotoxic/embryotoxic effect of tilmicosin, however, a maternotoxicity was observed at doses that were close to the therapeutic dosage. The product can be used in sows whatever the pregnancy stages.

The safety of tilmicosin has not been established in boars used for breeding purposes.

Do not use simultaneously with other macrolides and lincosamides.

Do not use simultaneously with bacteriostatic antimicrobial agents.

Tilmicosin may lessen the antibacterial activity of β-lactam antibiotics.

For oral administration after incorporation into feed.

The product should be administered to small quantities of feed for immediate consumption by individual animals. For treatment of groups of pigs, use an appropriate premix incorporated into medicated feedingstuff by an authorised feed manufacturer. Pigs to be treated should be separated and treated individually. The required quantity of the product should be thoroughly mixed into the daily ration for each individual pig. The feed containing the oral granules should be provided as the sole ration for the periods recommended. Individual pigs should receive 16 mg tilmicosin per kg bodyweight, corresponding to 160 mg Tilmovet 100 mg/g Oral Granules/kg bodyweight, once a day for 15 days. The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated. The correct quantity of the product should be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed. The product should only be added to dry non pelleted feed.

Vomiting and cardio-vascular collapse are symptoms of overdosing.

Pig: meat and offal 21 days.

Pharmacotherapeutic group: Antibacterials for systemic use, macrolides, tilmicosin ATC vet code: QJ01FA91

Tilmicosin is a mainly bactericidal semi-synthetic antibiotic of the macrolide group. It is believed to affect the bacterial protein synthesis in vitro and in vivo, without affecting the nucleic acid synthesis. It is mostly bacteriostatic. It has a bactericidal effect on Pasteurella spp. Tilmicosin has a wide spectrum of activity against Gram-positive organisms and is particularly active against Pasteurella, Actinobacillus pleuropneumoniae and Mycoplasma organisms of porcine origin. Tilmicosin has some activity against certain Gram-negative micro-organisms. Cross resistance between tilmicosin and other macrolide antibiotics has been observed.

Macrolides inhibit protein synthesis by reversibly binding to the 50S ribosomal subunit. Bacterial growth is inhibited by induction of the separation of peptidyl transfer RNA from the ribosome during the elongation phase. Ribosomal methylase, encoded by the erm gene, can precipitate resistance to macrolides by alteration of the ribosomal binding site. The gene that encodes for an efflux mechanism, mef, also brings about a moderate degree of resistance. Resistance is also brought about by an efflux pump that actively rids the cells of the macrolide. This efflux pump is chromosomally mediated by genes referred to as acrAB genes. Resistance of Pseudomonas species and other Gramnegative bacteria, enterococci and staphylococci may be precipitated by chromosomally controlled alteration of permeability or uptake of the drug.

Absorption: When administered to pigs via the oral route at a dose of 400 ppm in the feed (equivalent to approximately 21.3 mg/kg/day), tilmicosin moves rapidly out of the serum into areas of low pH. The highest concentration in the serum (0.23±0.08 μg/ml) was recorded on day 10 of medication, but concentrations above the limit of quantification (0.10 μg/ml) were not found in 3 out of 20 animals examined. Lung concentrations increased rapidly between days 2 and 4, but no significant changes were obtained following four days of dosing. The maximum concentration in lung tissue (2.59±1.01 μg/ml) was recorded on day 10 of medication.

Distribution: Following oral administration, tilmicosin is distributed throughout the body, but especially high levels are found in the lung and in lung tissue macrophages. It is also distributed in the liver and kidney tissues.

Biotransformation: Several metabolites are formed, the predominant one being identified as T1. However the bulk of the tilmicosin is excreted unchanged.

Elimination: Following oral administration, tilmicosin is excreted mainly via the bile into the faeces, but a small proportion is excreted via the urine.

Corn cobs

Liquid paraffin

Macrogolglycerol ricinoleate

Phosphoric acid, concentrated for pH adjustment

Do not mix into feed containing bentonite.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the container: 3 months

Feed to which the oral granules has been added should be replaced if not consumed within 24 hours.

Store in a dry place in the original container.

Do not store above 30ºC. Store in the original container in order to protect from moisture.

Pack of 0.25 kg or 1 kg in a polyethylene-lined 3-ply paper bag.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.

14/10/2009

July 2014

Nil.