DONA powder for oral solution

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

glucosamine (glucosamine sulfate)

متاح من:

Rottapharm Ltd.

ATC رمز:

M01AX05

INN (الاسم الدولي):

glucosamine (glucosamine sulfate)

جرعة:

1500mg, (20), (30) sachets

الشكل الصيدلاني:

powder for oral solution

الوحدات في الحزمة:

1500mg, (20), (30) sachets

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2018-09-17

خصائص المنتج

_ _
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_Translation from the German Language _
_ _
EXPERT INFORMATION(_German-type of Summary of Product Characteristics
/ SmPC_)
_ _
DONA
® 1500 MG, POWDER FOR ORAL SOLUTION _ _
1.
NAME OF THE MEDICINAL PRODUCT
Dona
®
1500 mg, powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: 1884 mg of glucosamine hemisulfate sodium
chloride (1:1),
equivalent to 1500 mg of glucosamine hemisulfate,equivalent to 1178 mg
of
glucosamine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of symptoms in mild to moderate osteoarthritis of the knee.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_ _
Unless otherwise prescribed by the doctor, the usual dosage is:
1 sachet daily.
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.
If no relief of symptoms is experienced after 2-3 months, continued
treatment with
glucosamine should be reconsidered.
_ _
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Additional information on special populations:
_Children and Adolescents:_
Glucosamine should not be used in children and adolescents below the
age of 18 years,
since efficacy and safety of the use have not been established.
_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 performed.
Method of administration
The contents of one sachet (dissolved in a glass of water) should be
taken preferably at
meals. _ _
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
dona
®
1500 mg, Powder for Oral Solution, must not be