מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
TIAMULIN FUMARATE
Huvepharma NV
QJ01XQ01
TIAMULIN FUMARATE
125 Mg/Ml
Oral Solution
POM
Porcine
Tiamulin
Antibacterial
Authorised
2010-02-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Tiamulin hydrogen fumarate 125 mg (equivalent to 101.2 mg tiamulin) EXCIPIENTS Methyl parahydroxybenzoate (E218) 0.90 mg Propyl parahydroxybenzoate 0.10 mg For the 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 In pigs For the treatment of swine dysentery caused by or further complicated by tiamulin-susceptible _Brachyspira_ _hyodysenteriae._ For the treatment of enzootic pneumonia and the reduction of lesions 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 substance or to any of the excipient. Do not use in the case of resistance to tiamulin. Do not administer products containing monensin, salinomycin, narasin, maduramicin 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/11/2014_ _CRN 7018032_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water, animals should be treated parenterally. Long term or repeated use should be avoided by improvi קרא את המסמך השלם