البلد: إسبانيا
اللغة: الإنجليزية
المصدر: HMA (Heads of Medicines Agencies)
tiamulin hydrogen fumarate 200 mg
Calier Portugal, S.A.
QJ01XQ01
Solution for injection
Tiamulin
Pigs
2010-02-24
PACKAGE LEAFLET CALIERMUTIN 162 mg/ml SOLUTION FOR INJECTION FOR PIGS (PT) 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT>: LABORATORIOS CALIER, S.A. C/ Barcelonès, 26. Pla del Ramassà. 08520 LES FRANQUESES DEL VALLÈS. BARCELONA. SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CALIERMUTIN 162 mg/ml SOLUTION FOR INJECTION FOR PIGS (PT) MACROMUTIN 162 mg/ml SOLUTION FOR INJECTION FOR PIGS (ES) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: Active Substances Tiamulin base ............................................................................................. 162,0 mg (Equivalent to tiamulin hydrogen fumarate) .............................................. 200,0 mg Excipients_ _ Butylparahydroxybenzoate ........................................................................... 0.32 mg Propylgallate (E310) ................................................................................... 0.162 mg 4. INDICATION(S) Swine dysentery: For the treatment of swine dysentery caused by _Brachyspira hyodysenteriae _ and complicated by _Bacteroides _spp and _Fusobacterium_ spp. Enzootic pneumonia complex of pigs: For the treatment of enzootic pneumonia complex, caused by _M. hyopneumoniae _and where the secondary bacteria are sensitive to tiamulin. Mycoplasmal arthritis: For the treatment of arthritis caused by _Mycoplasma hyosynoviae, _to reduce lameness and restore growth performance. 5. CONTRAINDICATIONS Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CALIERMUTIN 162 mg/ml SOLUTION FOR INJECTION FOR PIGS (PT) MACROMUTIN 162 mg/ml SOLUTION FOR INJECTION FOR PIGS (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substances Tiamulin base ................................................................................ 162.0 mg (Equivalent to tiamulin hydrogen fumarate) ................................... 200.0 mg Excipients Butylparahydroxybenzoate .............................................................. 0.32 mg Propylgallate (E310) ...................................................................... 0.162 mg For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow oily solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Porcine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Swine dysentery: For the treatment of swine dysentery caused by _Brachyspira _ _hyodysenteriae _and complicated by _Bacteroides _spp and _Fusobacterium_ spp. Enzootic pneumonia complex of pigs: For the treatment of enzootic pneumonia complex, caused by _M. hyopneumoniae _and where the secondary bacteria are sensitive to tiamulin. Mycoplasmal arthritis: For the treatment of arthritis caused by _Mycoplasma _ _hyosynoviae, _to reduce lameness and restore growth performance. 4.3 CONTRAINDICATIONS Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before and after treatment with Macromutin 162 mg/ml solution for injection for pigs. Severe growth depression or death may result. Do not u اقرأ الوثيقة كاملة