देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ampoule A-glucosamine (glucosamine sulfate), ampoule B-solvent
Biologici Italia Laboratories S.r.l.
M01AX05
ampoule A-glucosamine (glucosamine sulfate), ampoule B-solvent
200mg/ml
solution for i/m injection
(6) ampoule A 2ml, (6) ampoule B 1ml
Prescription
Registered
2017-06-08
_(SM080205SM01)/AF201109VZ02/VM070714VM03_ _ _ _ _ DONA ® GLUCOSAMINE SULFATE 400 MG SOLUTION FOR INJECTIONS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DONA ® 400 mg solution for injections 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each couple of ampoules contains: _Ampoule A_ _Active Ingredient _ Crystalline glucosamine sulfate 502.5 mg _equivalent to: glucosamine sulfate 400.0 mg _ _ _ _sodium chloride 102.5 mg_ _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injections for intramuscular use. _Description _ _of _ _the _ _product:_ brown ampoule A, containing Glucosamine Sulfate, and colourless ampoule B, containing the diluent solution. 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 One or two couples of ampoules can be administered by intramuscular route three times weekly for 4-6 weeks. Suck the content of ampoule A (brown) and ampoule B (colourless) in the same syringe. A slight yellow colouring of the solution in ampoule A does not influence the efficacy and tolerability of the product. The intramuscular administration can be usefully combined with the oral administration. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment and in some cases even longer. - 2 - _ _ _ADDITIONAL INFORMATION OF SPECIAL POPULATIONS _ _CHILDREN AND ADOLESCENTS _ Glucosamine should not be used in children and adolescents below the age of 18 years (see 4.4). _ELDERLY _ _ _ No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients. _IMPAIRED RENAL AND/OR LIVER FUNCTION _ _ _ In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been perfor पूरा दस्तावेज़ पढ़ें