Quốc gia: Bồ Đào Nha
Ngôn ngữ: Tiếng Anh
Nguồn: HMA (Heads of Medicines Agencies)
tilmicosin 100 mg/g
Huvepharma N.V.
QJ01FA91
Granules
tilmicosin
Pigs
2010-03-26
SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 100 MG/G ORAL GRANULES HUVEPHARMA NV Page 1 of 3 PACKAGE LEAFLET TILMOVET 100 MG/G GRANULES 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 holder Huvepharma NV, UItbreidingstraat 80, 2600 Antwerpen, Belgium Manufacturer Biovet JSC, 39 Petar Rakov Str, 4550 Peshtera – Bulgaria 2. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMOVET 100 MG/G OAL GRANULES for pigs tilmicosin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each g contains 100 mg of Tilmicosin. A Brown granulated powder 4. INDICATION(S) TILMOVET 100 mg/g Granules 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 not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Weaned fattening pigs SUMMARY OF PRODUCT CHARACTERISTICS TILMOVET 100 MG/G ORAL GRANULES H Đọc toàn bộ tài liệu
SKP –EN Versie TILMOVET 100 MG/G 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMOVET 100 MG/G GRANULES for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains 100 mg of Tilmicosin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules. A brown granulated powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Weaned fattening pigs. 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) 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. 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. SKP –EN Versie TILMOVET 100 MG/G 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 4.5I) 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 susceptibility testing and take into account official and local antimicrobial policies. Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiv Đọc toàn bộ tài liệu