País: Hungria
Língua: inglês
Origem: HMA (Heads of Medicines Agencies)
tilmicosin phosphate 100 g
Huvepharma N.V.
QJ01FA91
Premix for medicated feed
tilmicosin
Pigs
2010-03-26
SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 100 G/KG PREMIX Huvepharma NV Page 1 of 3 PACKAGE LEAFLET TILMOVET 100 G/KG PREMIX For medicated feeding stuff for pigs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation Huvepharma NV, UItbreidingstraat 80, 2600 Antwerpen, Belgium Manufacturer 1. Biovet JSC, 39 Petar Rakov Str, 4550 Peshtera – Bulgaria 2. Laboratorios Calier, Barcelones, 26 Pla del Ramassa, 08520 Les Franqueses del Valles, Spain 2. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMOVET 100 G/KG PREMIX For medicated feeding stuff for pigs tilmicosin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) _The product is a yellowish tan to reddish tan free-flowing granular material containing _100 g tilmicosin per kg 4. INDICATION(S) Tilmovet Premix is indicated for the treatment of pneumonia in weaned fattening pigs, caused by _Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella _ _multocida_ and other organisms sensitive to tilmicosin. 5. CONTRAINDICATIONS 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. 6. ADVERSE REACTIONS Occasionally, feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient. If you notice any serious effects or other effects n Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 100 G/KG PREMIX Huvepharma NV Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMOVET 100 G/KG PREMIX for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: 100 g tilmicosin per kg For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff A yellowish tan to reddish tan free-flowing granular material. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Weaned fattening pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Tilmovet Premix is indicated for the treatment of pneumonia in weaned fattening pigs, caused by _Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, _ _Pasteurella multocida_ sensitive to tilmicosin. 4.3 CONTRAINDICATIONS 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. 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) If for an individual animal, feed intake is such that the recommended dosage is not SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 100 G/KG PREMIX Huvepharma NV Page 2 of 6 realized, medication should be carried out by parenteral treatment. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Cross-resistance between tilmicosin and other macrolide antibiotic has been observed. Use of the product should be based on Leia o documento completo