Actovegin solution for injection

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

deproteinised haemoderivate of calf blood

Dostępny od:

Takeda Austria GmbH

Kod ATC:

առկա չէ (B06AB)

INN (International Nazwa):

deproteinised haemoderivate of calf blood

Dawkowanie:

40mg/ml

Forma farmaceutyczna:

solution for injection

Sztuk w opakowaniu:

(25/5x5/) ampoules 2ml, in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2016-09-15

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ACTOVEGIN®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For 2 ml ampules:
1 ampule contains: _active ingredient:_ Actovegin® concentrate (dry
mass)
1)
– 80.0
mg;
_Excipients:_ water for injections – up to 2 ml.
For 5 ml ampules:
1 ampule contains: _active ingredient:_ Actovegin® concentrate (dry
mass)
1)
– 200.0
mg;
_Excipients:_ water for injections – up to 5 ml.
For 10 ml ampules:
1 ampule contains: _active ingredient:_ Actovegin® concentrate (dry
mass)
1)
– 400.0
mg;
_Excipients:_ water for injections – up to 10 ml.
1)
Actovegin® concentrate contains Sodium Chloride as Sodium and
Chlorine
shaped ion which is calf blood components. Sodium Chloride is not
added or
removed within the process production. Content of Sodium Chloride
compunds
about 53.6 mg (for 2 ml ampules), about 134.0 mg (for 5 ml ampules)
and around
268.0 mg (for 10 ml ampules).
3. PHARMACEUTICAL FORM
Solution for injection
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
Actovegin® solution for injections is used for intra-arterial,
intravenous (including
infusions) and intramuscular administration.
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 times a week.
For administration as infusion, 10-50 ml is added to 200-300 ml basic
solution
(blood