ACTOVEGIN

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 nuclear 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 effect

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).

Violations 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

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