DONA solution for i/m injection

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

ampoule A-glucosamine (glucosamine sulfate), ampoule B-solvent

Disponible depuis:

Biologici Italia Laboratories S.r.l.

Code ATC:

M01AX05

DCI (Dénomination commune internationale):

ampoule A-glucosamine (glucosamine sulfate), ampoule B-solvent

Dosage:

200mg/ml

forme pharmaceutique:

solution for i/m injection

Unités en paquet:

(6) ampoule A 2ml, (6) ampoule B 1ml

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2017-06-08

Résumé des caractéristiques du produit

_(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