Država: Italija
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
tilmicosin phosphate 200 g
Huvepharma N.V.
QJ01FA91
Premix for medicated feed
tilmicosin
Pigs
2011-10-26
SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 200 G/KG PREMIX Huvepharma NV Page 1 of 3 PACKAGE LEAFLET TILMOVET 200 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 200 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 _ 200 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 effec Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 200 G/KG PREMIX Huvepharma NV Page 1 of 7 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMOVET 200 G/KG PREMIX for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: 200 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. SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 200 G/KG PREMIX Huvepharma NV Page 2 of 7 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) If for an individual animal, feed intake is such that the recommended dosage is not 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 Pročitajte cijeli dokument