Actovegin tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

deproteinised haemoderivate of calf blood

Available from:

Takeda Pharmaceuticals LLC

ATC code:

առկա չէ (B06AB) օրիգինալ դեղի հաջորդ արտադրատարածք

INN (International Name):

deproteinised haemoderivate of calf blood

Dosage:

200mg (50) in glass container

Pharmaceutical form:

tablets coated

Units in package:

200mg (50) in glass container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-11-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ACTOVEGIN®
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1
coated tablet contains :
Tablet core:
_ active ingredient: _
blood components – deproteinized calf blood derivative – 200.0
mg, as an Actovegin
®
granulate* – 345.0 mg
3. PHARMACEUTICAL FORM
Coated tablets
Description: Round biconvex bright greenish-yellow coated shiny
tablets
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
Orally, before food intake, without chewing, with a small amount of
fluid.
_Post-stroke _
_cognitive impairment _
In acute period of ischemic stroke, beginning from 5 – 7day, 2000 mg
per day intravenously
dropwise up to 20 infusions with subsequent switching to 2 tablets 3
times a day (1200 mg/day).
The overall duration of treatment is 6 months.
_Dementia _
2 tablets 3 times a day (1200 mg/day). The overall duration of
treatment is 20 weeks.
_Peripheral _
_perfusion disorders and their sequelae _
1-2 tablets 3 times a day (600 – 1200 mg/day). The duration of
treatment is 4 – 6 weeks.
_Diabetic polyneuropathy_
2000 mg a day intravenously dropwise 20 infusions with subsequent
switch to 3 tablets 3 times a
day (1800 mg/day). The duration is 4 – 5 months.
_Use in pediatric patients_
No data are currently available and usage is not recommended in
pediatric patients.
4.3 CONTRAINDICATIONS

Hypersensitivity to Actovegin
®
and similar preparations or their excipients.

Fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency.

Age below 18 years.
USE WITH CAUTION
Pregnancy and breastfeeding.
_ _
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE CLINICAL
DATA
In multicentre, randomized, double blind, pl