Ülke: Romanya
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
tiamulin fumarate 450 mg
Huvepharma N.V.
QJ01XX92
Granules for oral solution
tiamulin
Chicken, Pigs, Turkeys
2010-10-11
SKP, Etikettering en Bijsluiter – EN Versie VETMULIN 450 MG/G Page 1 of 15 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VETMULIN 450 MG/G granules for use in drinking water for pigs. (All MS except FR) Vetmulin 364 mg/g granules pour solution orale pour les porcs (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 364.2 mg tiamulin (as 450.0 mg Tiamulin hydrogen fumarate) For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM granules for use in drinking water . White to pale yellow granules 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Pigs For the treatment of swine dysentery caused by tiamulin-susceptible _Brachyspira _ _hyodysenteriae_. For the treatment of enzootic pneumonia caused by tiamulin-susceptible _Mycoplasma _ _hyopneumoniae._ The presence of the disease in the herd should be established before use. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient or to any excipient. Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least 7 days before or after treatment with Vetmulin 45 SKP, Etikettering en Bijsluiter – EN Versie VETMULIN 450 MG/G Page 2 of 15 See also section 4.8. 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Avoid interactions between tiamulin and the ionophore products monensin, Belgenin tamamını okuyun
SKP, Etikettering en Bijsluiter – EN Versie VETMULIN 450 MG/G Page 1 of 15 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VETMULIN 450 MG/G granules for use in drinking water for pigs. (All MS except FR) Vetmulin 364 mg/g granules pour solution orale pour les porcs (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 364.2 mg tiamulin (as 450.0 mg Tiamulin hydrogen fumarate) For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM granules for use in drinking water . White to pale yellow granules 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Pigs For the treatment of swine dysentery caused by tiamulin-susceptible _Brachyspira _ _hyodysenteriae_. For the treatment of enzootic pneumonia caused by tiamulin-susceptible _Mycoplasma _ _hyopneumoniae._ The presence of the disease in the herd should be established before use. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient or to any excipient. Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least 7 days before or after treatment with Vetmulin 45 SKP, Etikettering en Bijsluiter – EN Versie VETMULIN 450 MG/G Page 2 of 15 See also section 4.8. 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Avoid interactions between tiamulin and the ionophore products monensin, Belgenin tamamını okuyun