Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Glucosamine Sulfate
MYLAN HEALTHCARE SDN. BHD.
Glucosamine Sulfate
180 Capsules; 80 Capsules; 6 Capsules
ROTTAPHARM LTD
_SM090408CM01 _ VIARTRIL ® -S Glucosamine Sulfate CAPSULES 250 MG NAME OF THE MEDICINAL PRODUCT VIARTRIL ® -S COMPOSITION EACH CAPSULE CONTAINS: _ACTIVE INGREDIENT_ Crystalline glucosamine sulfate 314 mg _equivalent to: _ _glucosamine sulfate _ _250 mg_ _ _ _sodium chloride _ _64 mg_ _EXCIPIENTS _ Maize starch, Lactose, Magnesium stearate, Talc. PHARMACEUTICAL FORM AND PRESENTATION Capsules. Package of 80 and180 capsules. PHARMACO-THERAPEUTIC GROUP Product for the treatment of osteoarthritis. (Product for the musculoskeletal system - ATC code: M01AX05) MANUFACTURER ROTTAPHARM Ltd. Damastown Industrial Park, Mulhuddart DUBLIN 15 - IRELAND THERAPEUTIC INDICATIONS Treatment of the symptoms of osteoarthritis, i.e. pain and function limitation. CONTRA-INDICATIONS Hypersensitivity to glucosamine or to any of the excipients. As the active ingredient is obtained from seafood (shellfish), the product should not be given to patients who are allergic to shellfish. PRECAUTIONS FOR USE This medicinal product contains 50 mg of sodium per dose. The daily sodium intake is 150 mg. To be taken into consideration by patients on a controlled sodium diet. The administration in patients with severe hepatic or renal insufficiency should be made under medical supervision. SPECIAL WARNINGS The animal studies did not evidence any unfavourable effects on the reproductive functions or on lactation. In the absence of such studies in humans, the product during pregnancy and lactation should be used only under medical control. Administration during the first three months of pregnancy must be avoided. No effects on the ability to drive or to operate machines is expected. _ _ POSOLOGY AND METHOD OF ADMINISTRATION 2 capsules taken three times daily, preferably at meals. OVERDOSE No cases of accidental or intentional overdose are known. The animal acute and chronic toxicological studies indicate that toxic effects and symptoms of toxicity are not likely to occur, even after high overdoses. UNDESIRABLE EFFECTS The clinical trials have shown the g Izlasiet visu dokumentu