Nchi: Romania
Lugha: Kiingereza
Chanzo: HMA (Heads of Medicines Agencies)
tiamulin fumarate 100 mg
Huvepharma N.V.
QJ01XX92
Premix for medicated feed
tiamulin
Pigs
2011-06-27
SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 100 G/ KG Huvepharma NV Page 1 of 13 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmulin 100 g/kg premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each kg contains: Tiamulin 82 g (as Tiamulin hydrogen fumarate 100g) For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff A yellowish free-flowing granular material 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) For treatment and prevention, when the disease is present at herd level, of swine dysentery caused by _Brachyspira hyodysenteriae_ sensitive to tiamulin. The presence of disease in the herd should be established before use. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substances or any of the excipients. Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least seven days before or after treatment with the product. See section 4.8. SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 100 G/ KG Huvepharma NV Page 2 of 13 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) The uptake of medication by animals can be altered as a consequence of illness. For animals with a reduced feed intake, treat parenterally using an appropriate injectable product. Long term or repeated use should be avoided by improving management practice and thorough cleansing and disinfection. 4.5 SPECIAL PRECAUTIONS FOR USE 4.5.1 Special precautions for use in animals Do not use the product in liquid feed. Use of the product sh Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 100 G/ KG Huvepharma NV Page 1 of 13 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmulin 100 g/kg premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each kg contains: Tiamulin 82 g (as Tiamulin hydrogen fumarate 100g) For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff A yellowish free-flowing granular material 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) For treatment and prevention, when the disease is present at herd level, of swine dysentery caused by _Brachyspira hyodysenteriae_ sensitive to tiamulin. The presence of disease in the herd should be established before use. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substances or any of the excipients. Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least seven days before or after treatment with the product. See section 4.8. SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 100 G/ KG Huvepharma NV Page 2 of 13 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) The uptake of medication by animals can be altered as a consequence of illness. For animals with a reduced feed intake, treat parenterally using an appropriate injectable product. Long term or repeated use should be avoided by improving management practice and thorough cleansing and disinfection. 4.5 SPECIAL PRECAUTIONS FOR USE 4.5.1 Special precautions for use in animals Do not use the product in liquid feed. Use of the product sh Soma hati kamili