Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
tiamulin hydrogen fumarate 125 mg/ml
Huvepharma N.V.
QJ01XQ01
Oral solution
Tiamulin
Chicken, Pigs, Turkeys
2009-11-25
SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 125 MG/ML SOLUTION Huvepharma NV Page 1 of 16 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK, ES, IT, AT, DE, PT) VETMULIN VET, Oral Solution for use in drinking water for pigs (DK) Vetmulin 101.2 mg/ml Oral Solution for use in drinking water for pigs (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance 125 mg Tiamulin hydrogen fumarate (equivalent to 101.2 mg tiamulin Excipients Methyl parahydroxybenzoate (E218):0.90 mg Propyl parahydroxybenzoate (E216): 0.10 mg For a full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM Oral solution for use in drinking water Clear colourless to slightly yellow liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) For the treatment of swine dysentery caused by or further complicated by tiamulin- SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 125 MG/ML SOLUTION Huvepharma NV Page 2 of 16 susceptible _Brachyspira hyodysenteriae. _ Treatment of enzootic pneumonia and the reduction of lesions caused by tiamulin- susceptible _Mycoplasma hyopneumoniae _ SUMMARY OF PRODUCT CHARACTERISTICS VETMULIN 125 MG/ML SOLUTION Huvepharma NV Page 3 of 16 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Do not administer products containing monensin, salinomycin ,narasin, maduramycin or other ionophores during or for at least seven days before or after treatment with the product. See also section 5.1. and 4.8. Read the complete document