Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE
PCO Manufacturing
1500 Milligram
Powder for Oral Solution
2007-01-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dona 1500mg Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Excipients: Aspartame sorbitol For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution _Product imported from Greece, Italy and Spain._ A white, crystalline, odourless powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of osteoarthritis, i.e. pain and function limitation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE ELDERLY: The contents of one sachet (dissolved in a glass of water) should be taken once daily, preferably at meals. Pivotal proof of efficacy has been demonstrated for periods of up to three months, with a residual effect evident for two months after drug withdrawal. The safety and efficacy of the product were also confirmed in pivotal clinical trials for treatment up to three years. Continuous treatment beyond 3 years cannot be recommended as the safety has not been established beyond this period. CHILDREN AND ADOLESCENTS: Glucosamine should not be used in children and adolescents below the age of 18 years (see 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to glucosamine. The powder for oral solution contains aspartame and is therefore contraindicated in patients with phenylketonuria. Crystalline glucosamine sulfate 1884mg equivalent to: glucosamine sulfate 1500mg sodium chloride 384mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/08/2011_ _CRN 2095711_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Since glucosamine is obtained from shellfish, patients who are allergic to shellfish should exercise caution in the use of the Прочитайте повний документ