País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
SULFALENE
Farmitalia Carlo Erba Ltd
SULFALENE
2 Grams
Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kelfizine W Tablets, 2g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sulfalene (sulfametopyrazine) 2g. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White, flat, uncoated tablets marked ‘LONGUM’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of infections due to micro-organisms sensitive to this anti-infective, including chronic bronchitis and urinary tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over the age of 12 years The usual dose is 2 grams (i.e. one tablet) weekly. Each tablet should be stirred into half a tumbler full of water or orange squash. Elderly As hepatic conjugation and renal clearance occur at a reduced rate in the elderly, caution is advised when prescribing the drug for long periods of time to avoid accumulation. Children under 12 years of age Kelfizine W tablets are contra-indicated for use in children under 12. 4.3 CONTRAINDICATIONS Kelfizine W Tablets are contra-indicated in: Children aged 12 years and less. Lactating women who are breast feeding infants. Patients hypersensitive to sulphonamides. Patients suffering from porphyria, jaundice, intestinal obstruction or renal failure. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/07/2006_ _CRN 2025394_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This drug should only be used with great caution in patients with hepatic or renal dysfunction, dehydration or blood dyscrasias. Absorption of this sulphonamide may be increased in patients with ulcerative lesions of the bowel. Adequate fluid intake should be ensured during administration. Prolonged use of any anti-infe Leia o documento completo