Actovegin instructions
Actovegin tablets -
official * instructions for use
* registered by the Ministry of Health of the Russian Federation
Registration number:
P N014635 / 03
Trade name:
Actovegin®
Grouping name:
Deproteinized hemoderivat blood of calves
Dosage Form:
coated tablets.
Composition:
1 coated tablet contains:
Kernel: active substance: blood components: deproteinized
blood hemoderivate of calves - 200.0 mg in the form of Actovegin® granulate * -
345.0 mg, excipients: magnesium stearate - 2.0 mg, talc - 3.0 mg;
Shell: acacia gum - 6.8 mg, mountain glycolic wax -
0.1 mg, hypromellose phthalate - 29.45 mg, diethyl phthalate - 11.8 mg,
aluminum quinoline yellow lacquer dye - 2.0 mg, macrogol-6000 - 2 , 95 mg,
povidon-K 30 - 1.54 mg, sucrose -52.3 mg, talc - 42.2 mg, titanium dioxide -
0.86 mg.
* Actovegin® granulate contains: active substance:
blood components: deproteinized blood hemoderivate of calves - 200.0 mg,
excipients: Povidone-K 90 - 10.0 mg, microcrystalline cellulose - 135.0 mg.
Description:
round biconvex tablets, coated greenish-yellow color,
shiny.
Pharmacotherapeutic group:
tissue regeneration stimulator.
ATX code:
[B06AB]
Pharmachologic action
Pharmacodynamics
Actovegin® is an antihypoxant that has three types of
effects: metabolic, neuroprotective, and microcirculatory. Actovegin® increases
the absorption and utilization of oxygen; The phospho-oligosaccharides
contained in the preparation of inositol have a positive effect on glucose
transport and utilization, which leads to an improvement in the energy
metabolism of cells and a decrease in the formation of lactate under ischemic
conditions.
We consider several ways to implement the
neuroprotective mechanism of action of the drug.
Actovegin® prevents the development of apoptosis
induced by beta-amyloid peptide (AP25-35).
Actovegin modulates the activity of the nuclear factor
Kappa B (NF-kB), which plays an important role in the regulation of apoptosis
and inflammation in the central and peripheral nervous system.
Another mechanism of action is associated with the
nucleus enzyme poly (ADP-ribose) -polymerase (PARP). PARP plays an important
role in identifying and repairing single-stranded DNA damage, but
over-activation of the enzyme can trigger cell death processes in such
conditions as cerebrovascular diseases and diabetic polyneuropathy. Actovegin®
inhibits PARP activity, which leads to a functional and morphological
improvement of the central and peripheral nervous system.
The positive effects of Actovegin®, affecting
microcirculation and the endothelium, are an increase in capillary blood flow
rate, a decrease in the pericapillary zone, a decrease in myogenic tone of
precapillary arterioles and capillary sphincters, a decrease in the degree of
arterio-ventricular shunting blood flow in a heart of a heart of a heart and a
heart. nitric oxide, affecting the microcirculatory bed.
In the course of various studies, it was found that
the effect of Actovegin® occurs no later than 30 minutes after taking it. The
maximum effect is noted 3 hours after parenteral and 2-6 hours after oral
administration.
Pharmacokinetics
Using pharmacokinetic methods, it is impossible to
study the pharmacokinetic parameters of Actovegin®, since it consists only of
physiological components that are usually present in the body.
Indications
In the complex therapy:
- Symptomatic treatment of cognitive impairment,
including post-stroke cognitive impairment and dementia.
- Symptomatic treatment of peripheral circulatory
disorders and their consequences.
- Symptomatic treatment of diabetic polyneuropathy
(DPN).
Contraindications
- Hypersensitivity to the drug Actovegin® and
similar drugs or excipients.
- Fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase deficiency.
- Children's age up to 18 years.
Carefully
Pregnancy and breastfeeding period.
Use during pregnancy and during breastfeeding
Actovegin® should be used only in cases where
therapeutic benefit outweighs the potential risk to the fetus or child.
Dosage and administration
Inside, without chewing, before food, washing down
with a small amount of liquid.
Post-stroke cognitive impairment
In the acute period of ischemic stroke, starting from
5-7 days, 2000 mg per day intravenous drip to 20 infusions with switching to a
tablet form 2 tablets 3 times a day (1200 mg / day). The total duration of
treatment is 6 months.
Dementia
2 tablets 3 times a day (1200 mg / day). The total
duration of treatment is 20 weeks.
Peripheral circulatory disorders and their
consequences
1-2 tablets 3 times a day (600 - 1200 mg / day).
Duration of treatment from 4 to 6 weeks.
Diabetic polyneuropathy
At 2000 mg per day intravenous drip 20 infusions with
the transition to the tablet form 3 tablets 3 times a day (1800 mg / day)
duration from 4 to 5 months.
Side effects
The frequency of side effects was determined in
accordance with the classification of the Council of International Medical
Scientific Organizations (CIOMS): very often (≥ 1/10); often (≥ 1/100 to
<1/10); infrequently (≥ 1/1000 to <1/100); rarely (≥ 1/10000 to
<1/1000); very rarely (<1/10000); not known (cannot be estimated
according to the available data).
Immune system disorders
Rarely: allergic reactions (drug fever, symptoms of
shock).
Disorders of the skin and subcutaneous tissue
Rarely: urticaria, sudden redness.
Overdose
According to preclinical studies, Actovegin® does not
show toxic effects even when the dose is exceeded by 30-40 times compared to
the doses recommended for use in humans. There were no cases of overdose with
Actovegin®.
Interaction with other drugs
Currently unknown.
Special instructions
Clinical data
In the multicenter, randomized, double-blind,
placebo-controlled study ARTEMIDA (NCT01582854), which aimed to study the
therapeutic effect of Actovegin® on cognitive impairment in 503 patients with
ischemic stroke, the overall incidence of serious adverse events and death was
the same in both treatment groups. Although the frequency of recurrent ischemic
strokes was within the expected in this patient population, a greater number of
cases were recorded in the group that took Actovegin® compared to the placebo
group, but this difference was not statistically significant. The relationship
between cases of re-stroke and the study drug has not been established.
Use in pediatric patients
Currently, data on the use of the drug Actovegin® in
children are not available, so its use in this group of individuals is not
recommended.
Influence on ability to drive a car and other
mechanisms
Not installed.
Release form
200 mg coated tablets.
On 50 tablets in bottles of dark glass with a screw
mouth, corked by caps aluminum with control of the first opening.
1 bottle with the instruction for application is
placed in a pack from a cardboard. Transparent protective round stickers with
holographic inscriptions and control of the first opening are glued onto the
pack.
In the case of production and / or packaging and
packaging of the drug at Takeda Pharmaceuticals LLC, Russia:
On 50 tablets in bottles of dark glass with a screw
mouth, corked by caps aluminum with control of the first opening.
1 bottle with the instruction for application is
placed in a pack from a cardboard. Transparent protective round stickers with
holographic inscriptions and control of the first opening are glued onto the
pack.
In the case of packaging and packaging of the drug at
ZAO Sotex FarmFirma, Russia:
On 10, 30 or 50 tablets in bottles of dark glass with
a screw mouth, corked by caps aluminum with control of the first opening.
1 bottle with the instruction for application is
placed in a pack from a cardboard.
Shelf life
3 years. Do not use after expiration date.
Storage conditions
In the dark place at a temperature of no higher than
25 ° C.
Keep out of the reach of children!
Release conditions
Prescription.
The legal entity in whose name the registration certificate is issued
Takeda Pharmaceuticals Ltd.
Russia, 119048, Moscow, st. Usacheva, 2, p. 1
Manufacturer
Takeda GmbH, Germany
Lenitzstrasse 70-98, 16515 Oranienburg, Germany
(sugar coating - Haupt Pharma Berlin GmbH,
Moosrozenshtrasse 7, 12347 Berlin, Germany)
Takeda GmbH, Germany
Lehnitzstrasse 70-98, 16515 Oranienburg, Germany
(sugar coating - Haupt Pharma Berlin GmbH,
Moosrosenstrasse 7, 12347 Berlin, Germany)
or
Globofarm Pharmatshoytishe Productsnons und
Handelsgesellschaft mbH, Austria Breitenfurterstraße 251, 1230 Vienna, Austria
Globopharm Pharmazeutische Produktions- und
Handelsgesellschaft mbH, Austria Breitenfurterstrasse 251, 1230 Wien, Austria
or
Takeda Pharmaceuticals Ltd.
Russia, 150066, Yaroslavl, ul. Technoparkovaya, d.9.
Packer / QC Issuer
Takeda G mbH, Germany
Lenitzstrasse 70-98, 16515 Oranienburg, Germany
Takeda GmbH, Germany
Lehnitzstrasse 70-98, 16515 Oranienburg, Germany
or
Takeda Austria G mbH, Austria.
Art. Peter-Straße 25, 4020 Linz, Austria
Takeda Austria GmbH, Austria
St. Peter-Strasse 25, 4020 Linz, Austria
or
Takeda Pharmaceuticals Ltd.
Russia, 150066, Yaroslavl, ul. Technoparkovaya, 9,
or
Sotex FarmFirm CJSC
Russia, 141345, Moscow Region,
Sergiev Posad Municipal District,
rural settlement Bereznyakovskoe, pos. Belikovo, d.11.
Consumer complaints should be sent to the address of the legal entity in whose name the registration certificate was issued:
Takeda Pharmaceuticals Ltd., Moscow, Russia.
When packaging and packaging the drug at Sotex
FarmFirma CJSC, consumer claims should be sent to Sotex Pharmaceutical CJSC
CJSC.
March 31, 2019