Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
ALMITRINE BISMESYLATE
Servier Laboratories (Ireland) Ltd
50 Milligram
Tablets
1984-11-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vectarion 50 mg Film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of Almitrine Bismesylate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film- coated tablets. White, convex rod-shaped, tablets with a score mark on each surface. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic obstructive lung disease and respiratory failure associated with hypoxaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route. The usual daily dose is 50 to 100 mg (1 to 2 tablets daily), divided into two doses. Absorption is improved if drug is taken with food. Balanced oxygen therapy may be administered simultaneously. On the basis of experience to date it is recommended that after an initial 3 month treatment period, there should be an interval of one month without treatment. This can then be followed by a maintenance regime of two months on treatment and one month off treatment. It is also recommended that the dose should be adjusted in relation to the patient's weight, the severity of the blood gas abnormality and the incidence of adverse reactions as follows: _Weight_ For patients weighing less than 50 kg, the dose should be reduced to 1 tablet per day. _Blood gases_ Occasionally the severity of the modification of these parameters warrants the dose to be increased to 3 or 4 tablets daily, but this should be undertaken for short periods of time only. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/09/2007_ _CRN 2041442_ _page number: 1_ 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the active ingredients. Use during pregnancy, or lactation in women breast Olvassa el a teljes dokumentumot