Страна: Испания
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
tiamulin hydrogen fumarate 12.5 g
Laboratorios Calier
QJ01XX92
Oral solution
tiamulin
Chicken Food, Pigs Food
2008-05-20
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer LABORATORIOS CALIER, S.A. C/ Barcelonès, 26. Pla del Ramassà. 08520 LES FRANQUESES DEL VALLÈS. BARCELONA. Tel: 93 849 51 33 Fax: 93 840 13 98 e-mail: laboratorios@calier.es 2. NAME OF THE VETERINARY MEDICINAL PRODUCT MACROMUTIN 125 mg/ml ORAL SOLUTION FOR POULTRY AND PIGS (ES) CALIERMUTIN 125 mg/ml ORAL SOLUTION POULTRY AND PIGS (PT) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each ml contains: Active substance: Tiamulin............................................................................................. 101.2 mg Equivalent to Tiamulin hydrogen fumarate ...................................... 125.0 mg Excipients: Methyl parahydroxybenzoate (E219) ................................................... 0.9 mg Propyl parahydroxybenzoate (E217).................................................... 0.1 mg 4. INDICATION(S) Poultry (Broilers, layer hens, breeder hens and turkeys): Treatment and prevention of chronic respiratory disease (CRD) caused by strains sensitive to tiamulin: _Mycoplasma gallisepticum, Mycoplasma meleagridis_. Porcine: - Treatment of enzootic pneumonia caused by strains sensitive to tiamulin: _Mycoplasma hyopneumoniae, Mycoplasma hyorhinis_. - Treatment of haemorrhagic dysentery caused or complicated by strains sensitive to tiamulin: _Brachyspira hyodysenteriae_ 5. CONTRAINDICATIONS Do not use the product with monovalent ionophore antibiotics, 7 days before, during and 7 days after the treatme Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE VETERINARY MEDICINAL PRODUCT MACROMUTIN 125 mg/ml ORAL SOLUTION POULTRY AND PIGS (ES) CALIERMUTIN 125 mg/ml ORAL SOLUTION POULTRY AND PIGS (PT) 2 . QUALITATIVE AND QUANTITATIVE COMPOSITION: Each ml contains: Active substance: Tiamulin .......................................................................................... 101.2 mg Equivalent to Tiamulin hydrogen fumarate ............................... 125.0 mg Excipients: Methyl parahydroxybenzoate (E219) ............................................. 0.9 mg Propyl parahydroxybenzoate (E217) ............................................. 0.1 mg For a full list of excipients, see section 6.1. 3 . PHARMACEUTICAL FORM: Solution to be administrated in drinking water. Clear and colourless to pale yellow solution 4 . CLINICAL PARTICULARS: 4.1 TARGET SPECIES: Poultry (Broilers, layer hens, breeder hens and turkeys) and Porcine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES: POULTRY (BROILERS, LAYING HENS, BREEDER HENS AND TURKEYS): Treatment and prevention of chronic respiratory disease (CRD) caused by tiamulin sensitive strains: _Mycoplasma gallisepticum_, _Mycoplasma meleagridis._ PORCINE: Treatment of enzootic pneumonia caused by tiamulin sensitive strains: _Mycoplasma_ _hyopneumoniae_, _Mycoplasma hyorhinis. _ _ _ Treatment of haemorrhagic dysentery caused or complicated by tiamulin sensitive strains: _Brachyspira_ _hyodysenteriae _ _ _ 4.3 CONTRAINDICATIONS: Do not use the product with monovalent ionophore antibiotics, 7 days before, during and 7 days after treatment of animals. 4.4 Прочитать полный документ