Actovegin solution for injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

deproteinised haemoderivate of calf blood

Διαθέσιμο από:

“Takeda Pharmaceuticals” LLC

Φαρμακολογική κατηγορία (ATC):

առկա չէ (B06AB)

INN (Διεθνής Όνομα):

deproteinised haemoderivate of calf blood

Δοσολογία:

40mg/ml

Φαρμακοτεχνική μορφή:

solution for injection

Μονάδες σε πακέτο:

(5/1x5/) ampoules 5ml, in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-12-30

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ACTOVEGIN®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule 2 ml contains Actovegin concentrate as an active
ingredient (based on anhydrous
deproteinized calf blood derivative)
1)
– 80 mg;
_excipients: _water for injection up to 2 ml.
Each ampoule 5 ml contains Actovegin concentrate as an active
ingredient (based on anhydrous
deproteinized calf blood derivative)
1)
– 200 mg;
_excipients: _water for injection up to 5 ml.
Each ampoule 10 ml contains Actovegin concentrate as an active
ingredient (based on anhydrous
deproteinized calf blood derivative)
1)
– 400 mg;
_excipients:_ water for injection up to 10 ml.
1)
Actovegin
®
concentrate contains sodium and chloride ions, which are the
components of calf
blood. Sodium Chloride is not added or removed during the concentrate
manufacturing process.
Quantity of Sodium Chloride is about 53,6 mg (for ampoule 2 ml), about
134,0 mg (for ampoule
5 ml) and about 268,0 mg (for ampoule 10 ml).
3. PHARMACEUTICAL FORM
Solution for injection
Description:
Clear yellowish solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As part of combined therapy:

Symptomatic
treatment
of
cognitive
impairment
including
post-stroke
cognitive
impairment and dementia;

Symptomatic treatment of peripheral perfusion disorders and their
sequelae;

Symptomatic treatment of diabetic polyneuropathy (DPN).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intra-arterial, intravenous, intramuscular administration, and may
also be added to infusion
solutions.
Directions for use of one-point-cut ampoules:
Hold
the
ampoule
with
the
colored dot facing up. Make
sure to remove all the liquid
from the top of the ampoule
by gently shaking and tapping
it with a finger.
Hold
the
ampoule
with
the
colored dot facing up. Snap the
ampoule tip as shown in the
picture.
Corresponding to the severity of the clinical picture, initially 10-20
ml i.v. or i.a. daily; for further
treatment, 5 ml i.v. or slowly i.m. daily or several