200g/kg Tilmicosin (as phosphate)

Premix for medicated feeding stuff.

A yellowish tan to reddish tan free-flowing granular material.

Pigs and rabbits.

Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.

Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.

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 the active substance or to any of the excipients

Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy.

Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge susceptibility of the target pathogens at farm level, or at local/regional level.

Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

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.

Personal protective equipment consisting of overalls, safety glasses, impervious gloves and 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 should be worn when handling the veterinary medicinal product.

Do not eat, drink or smoke when handling this veterinary medicinal product. Wash hands after use.

In case of accidental ingestion, wash out mouth immediately with water and seek medical advice immediately and show the label to the physician.

In case of accidental spillage onto skin, wash thoroughly with soap and water and seek medical advice immediately and show the label to the physician.

In case of accidental eye contact, flush the eyes with plenty of clean, running water and seek medical advice immediately and show the label to the physician.

People with known hypersensitivity to tilmicosin should avoid contact with the veterinary medicinal product.

If you develop symptoms following exposure, such as skin rash, seek medical advice and show label to the physician. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

The primary route of environmental exposure is from manure applied to agricultural land as fertilizer. Tilmicosin degrades/declines slowly in the soil. Therefore, to protect soil and ground water, pig manure should not be spread onto grass land and when spread onto arable land should be plough to a depth of 30 cm. Environmental assessments have demonstrated that the use of the veterinary medicinal product as indicated is not expected to have any impact on the environment.

Not applicable.

Pigs and rabbits:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Reduced food intake1

1Transient

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the label for respective contact details.

The safety of the veterinary medicinal product has not been established during pregnancy. Do not use in breeding animals.

None known.

In feed use.

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of tilmicosin may need to be adjusted accordingly.

Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula

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.

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 veterinary medicinal product, it should first be mixed with a suitable quantity of feed ingredients (20-50 kg) before incorporation into the finished feed.

This veterinary medicinal product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C.

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.

This veterinary medicinal product is intended to be used for the preparation of medicated feed.

Pigs:

Meat and offal: 21 days

Rabbits:

Meat and offal: 4 days

Pharmacotherapeutic group: antibacterials for systemic use, macrolides

ATC vet code: QJ01FA91.

Tilmicosin is a semi-synthetic antibiotic of the macrolide group, and is believed to affect protein synthesis. It has bacteriostatic action but at high concentrations it may be bactericidal. This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine and avian origin. In particular its activity has been demonstrated against the following micro-organism:

Scientific evidence suggests that macrolides act synergistically with the host immune system. Macrolides appear to enhance phagocyte killing of bacteria. Tilmicosin has been shown to inhibit in vitro the replication of the Porcine Reproductive and Respiratory Syndrome virus in alveolar macrophages in a dose dependent fashion.

Cross resistance between tilmicosin and other macrolides and lincomycin has been observed.

Absorption: When administered to pigs via the oral route at a dose of 400 mg tilmicosin/kg feed (equivalent to approximately 21.3 mg tilmicosin/kg bodyweight/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.

When administered at a dose of 200 mg tilmicosin/kg feed (equivalent to approximately 11.0 mg/kg/day), plasma concentrations above the limit of quantification (0.10 μg/ml) were found in 3 out of 20 animals examined. Quantifiable levels of tilmicosin were found in lung tissue with the maximum concentration (1.43±1.13 μg/ml) being recorded on day 10 of medication.

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

Absorption: When administered orally to rabbits at a dose of 12 mg tilmicosin/kg b.w. as a single dose there is a quick absorption. Maximum concentrations were reached in 30 minutes, being the Cmax obtained of 0.35 μg/ml. Tilmicosin plasma concentrations decreased to 0.1 μg/ml within 2 hours and to 0.02 μg/ml after 8 hours. The elimination half-life was 22 hours.

Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in lungs. After 5 days of treatment with medicated feed at a dosage of 200 ppm of the veterinary medicinal product, tilmicosin concentrations in lung tissues were of 192 ± 103 μg/g.

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

Ground corn cobs

Not to be incorporated into feeds containing bentonite.

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

Store in a dry place

Do not store above 25°C.

Protect from direct sunlight.

Polyethylene/polyamide/polyethylene (inner layer) bag of 10kg

A preformed block bottomed bag of 1 kg constructed using a paper/polyethylene/aluminium/polyethylene/paper laminate either stitched closed or heat-sealed

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

N/A

Vm 00879/4170

17 November 1995

May 2025