Tilmicosin 200 mg/g.
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ANTIBIOTIC
Tilmicodem
Formula
Each gram of product contains:
Tilmicosin (active substance): 200 mg
Target species
Pigs.
Indications
For treatment and metaphylaxis (where the diagnosis has been confirmed) of respiratory infections associated with Actinobacillus pleuropneumoniae, Haemophilus parasuis, Pasteurella multocida susceptible to tilmicosin.
Administration
Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 40 – 80 mg Tilmicodem premix/kg bw/day) for a period of 15 days.
The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed 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 use in case of hypersensitivity to tilmicosin or to any of the excipients.
Horses or other Equidae, must not be allowed access to feeds containing tilmicosin. Horses fed with tilmicosin medicated feed may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Side effects
In very rare cases, feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient.
Special precautions for storage
Keep away from reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening of primary package: 28 days.
Shelf life after incorporation into meal or pelleted feed: 3 months.
Do not use after expiry date which is stated on the label.
Advice on correct administration
This product must be incorporated by feed manufacturers under specialist supervision. 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.
Withdrawal period
Meat and offal: 14 days.
Special warnings
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. Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given 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.
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 the leaflet or label of the product. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
The product can be used in pregnant sows. The safety of tilmicosin has not been established in boars used for breeding purposes.
There are no known interactions with other medicinal products or other forms of interaction.
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.
Special precautions for the disposal of unused product or waste materials
For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Other information
Bags 100g, 500g, 1kg, 5kg or 10 kg premix.
Not all pack sizes may be marketed.
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