Dona 1500mg Powder for Oral Solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Glucosamine sulfate as crystalline glucosamine sulfate

Disponible desde:

Imbat Limited

Código ATC:

M01AX; M01AX05

Designación común internacional (DCI):

Glucosamine sulfate as crystalline glucosamine sulfate

Dosis:

1500 milligram(s)

formulario farmacéutico:

Powder for oral solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Estado de Autorización:

Authorised

Fecha de autorización:

2007-11-30

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 1500mg Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Crystalline glucosamine sulfate
1884mg
equivalent to:
glucosamine sulfate
1500mg
sodium chloride
384mg
*Excipients - sodium, aspartame (E951) and sorbitol (E420).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
_Product imported from Italy and Spain:_
A white, crystalline, odourless powder for oral solution in single
dose sachets.
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
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.
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 re-evaluated.
ELDERLY:
No specific studies have been performed in elderly, but according to
clinical experience dosage adjustment is not
required when treating otherwise healthy, elderly patients.
PATIENTS WITH 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 (see also section 4.4)
CHILDREN AND ADOLESCENTS:
Glucosamine should not be used in children and adolescents below the
age of 18 years (see 4.