Actovegin. Actovegin - instructions for use, reviews, analogs and forms of release (tablets, injections in ampoules for injection, ointment, gel and cream) drugs for the treatment of metabolic disorders of the brain in adults, children (newborns) and during pregnancy

  • Date: 23.06.2020

Tissue regeneration stimulator

Solution for infusion in sodium chloride solution 0.9%, 4 mg / ml, 8 mg / ml or in dextrose solution, 4 mg / ml. 250 ml in a colorless glass infusion bottle (type II according to the European Pharmacopoeia), sealed with a stopper and an aluminum cap for running in, top closed with a lid that provides control of the first opening. 1 vial placed in a cardboard box. Transparent protective stickers of a round shape with holographic inscriptions and control of the first opening are pasted on the pack.

Solution for injections, 40 mg/ml. 2, 5, 10 ml of the drug in colorless glass ampoules (type I according to the European Pharmacopoeia) with a break point. 5 amp. in plastic blisters. 1 or 5 blister packs in a carton box. Transparent protective stickers of a round shape with holographic inscriptions and control of the first opening are pasted on the pack.

deproteinized hemoderivative blood of calves.

pharmachologic effect- metabolic.

Currently unknown.

However, in order to avoid possible pharmaceutical incompatibility, it is not recommended to add other drugs to Actovegin ® infusion solution.

pharmachologic effect- metabolic.

Antihypoxant. Actovegin ® is a hemoderivate, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 Da pass).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of the plasma membranes of cells during ischemia and a decrease in lactate formation), thus has an antihypoxic effect, which begins to manifest itself no later than 30 minutes after parenteral administration and reaches a maximum in after an average of 3 hours (2-6 hours).

Actovegin ® increases the concentration of ATP, ADP, phosphocreatine, as well as amino acids - glutamate, aspartate and GABA.

For Actovegin solution for infusion in sodium chloride solution and injection

The effect of Actovegin ® on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy (DPN).

In patients with diabetes mellitus and DPN, Actovegin ® significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness in the lower extremities).

Objectively, sensitivity disorders are reduced, the mental well-being of patients improves.

metabolic and vascular disorders of the brain (including ischemic stroke, TBI);

wound healing (ulcers of various etiologies, burns, trophic disorders (pressure sores), impaired wound healing processes);

prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy;

peripheral (arterial and venous) vascular disorders and their consequences (angiopathy, trophic ulcers);

diabetic polyneuropathy.

hypersensitivity to the drug Actovegin ® or similar drugs.

decompensated heart failure;

pulmonary edema;

oliguria;

fluid retention in the body.

Carefully: hyperchloremia, hypernatremia.

The use of the drug in pregnant women did not cause negative effects on the mother or fetus. However, when used in pregnant women, the potential risk to the fetus must be considered.

In / a, in / in(including in the form of infusion), i/m.

In connection with the potential for the development of anaphylactic reactions, it is recommended to test for the presence of hypersensitivity to the drug before infusion.

Ischemic stroke. 250-500 ml of solution for infusion in sodium chloride solution (1000-2000 mg of the drug) per day i.v. for 2 weeks or 20-50 ml of solution for injection (800-2000 mg of the drug) in 200-300 ml 0.9 % sodium chloride solution or 5% dextrose solution intravenously for 1 week, then 10–20 ml (400–800 mg of the drug) intravenously daily for 1 week, then 10–20 ml ( 400-800 mg of the drug) intravenously for 2 weeks. Then - the transition to the tablet form.

Metabolic and vascular disorders of the brain. 250–500 ml of solution for infusion (1000–2000 mg of the drug) per day or 5–25 ml of solution for injection (200–1000 mg of the drug) per day i.v. daily for 2 weeks, followed by switching to a tablet form or further - 250 ml IV several times a week (for infusions in dextrose solution).

Peripheral (arterial and venous) vascular disorders and their consequences. 250 ml (1000 mg) solution for intravenous or intravenous infusion daily or several times a week, followed by the transition to a tablet form (for infusion in sodium chloride solution). Or 20-30 ml of injection (800-1200 mg of the drug) in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution intravenously or intravenously daily for 4 weeks.

Diabetic polyneuropathy. 250-500 ml solution for infusion in a solution of sodium chloride or 50 ml solution for injection (2000 mg of the drug) per day intravenously for 3 weeks, followed by the transition to a tablet form - 2-3 tables. 3 times a day for at least 4-5 months.

Wound healing. 250 ml solution for infusion (1000 mg of the drug) IV daily or several times a week, depending on the rate of healing. Or 10 ml injection (400 mg) IV or 5 ml IM daily or 3-4 times a week, depending on the healing process. Possible combined use with dosage forms of Actovegin ® for external use.

Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy. 250 ml solution for infusion (1000 mg of the drug) intravenously the day before and daily during radiation therapy, as well as within 2 weeks after its completion, followed by the transition to a tablet form (for infusion in sodium chloride solution). The rate of administration is about 2 ml/min. Or 5 ml of injection (200 mg) IV daily during breaks in radiation exposure.

For Actovegin solution for injection, in addition

radiation cystitis. Transurethral, ​​daily, 10 ml injection (400 mg of the drug) in combination with antibiotic therapy. The rate of administration is about 2 ml/min.

The duration of the course of treatment is determined individually according to the symptoms and severity of the disease.

Instructions for use of ampoules with a break point

1. Place the tip of the ampoule with the breaking point up.

2. Gently tapping with your finger and shaking the ampoule, allow the solution to flow down from the tip of the ampoule.

3. Break off the tip of the ampoule at the break point by moving away from you.

Allergic reactions (skin rash, skin flushing, hyperthermia), up to anaphylactic shock.

Currently, data on drug overdose are limited.
Treatment for overdose: symptomatic therapy.

With repeated injections of the solution for infusion, the water-electrolyte balance of the blood plasma should be monitored.

Infusion solution and injection solution have a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or its tolerability.

Do not use an opaque solution or a solution containing foreign particles. After opening the vial (ampoule), the solution can not be stored.

In the case of the / m method of administration, the drug is administered slowly, not more than 5 ml. Due to the possibility of an anaphylactic reaction, a trial injection (2 ml IM) is recommended.

In a place protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

INN: Deproteinized hemoderivat from calf blood

Manufacturer: Takeda Austria GmbH

Anatomical-therapeutic-chemical classification:

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 121855

Registration period: 10.12.2015 - 10.12.2020

Instruction

Tradename

Actovegin®

International non-proprietary name

Dosage form

Solution for injection 40 mg / ml - 2 ml, 5 ml

Compound

1 ml contains

active substance - deproteinized hemoderivate of calf blood (in terms of dry matter) * 40.0 mg.

Excipients: water for injections

*contains approximately 26.8 mg sodium chloride

Description

Clear, yellowish solution.

Pharmacotherapeutic group

Other hematological preparations

ATX code B06AB

Pharmacological properties

Pharmacokinetics

It is impossible to study the pharmacokinetic characteristics (absorption, distribution, excretion) of Actovegin®, since it consists only of physiological components that are usually present in the body.

Actovegin® has an antihypoxic effect, which begins to appear at the latest 30 minutes after parenteral administration and reaches a maximum after an average of 3 hours (2-6 hours).

Pharmacodynamics

Actovegin® antihypoxant. Actovegin® is a hemoderivate, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons pass). Actovegin® causes an organ-independent intensification of energy metabolism in the cell. The activity of Actovegin® was confirmed by measuring increased absorption and increased utilization of glucose and oxygen. These two effects are interrelated, and they lead to an increase in the production of ATP, thereby providing a greater extent for the energy needs of the cell. Under conditions that limit the normal functions of energy metabolism (hypoxia, lack of substrate), and with increased energy consumption (healing, regeneration), Actovegin® stimulates the energy processes of functional metabolism and anabolism. The secondary effect is increased blood supply.

The effect of Actovegin® on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy (DPN).

In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin® significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, parasthesia, numbness in the lower extremities). Objectively, sensitivity disorders are reduced, the mental well-being of patients improves.

Indications for use

 metabolic and vascular disorders of the brain (including dementia);

- peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, venous ulcers of the lower extremities); diabetic polyneuropathy.

Dosage and administration

Actovegin®, solution for injection, is used intramuscularly, intravenously (including in the form of infusions) or intra-arterially.

Instructions for using ampoules with one break point:

take the ampoule so that the top containing the label is at the top. Gently tapping with your finger and shaking the ampoule, allow the solution to flow down from the tip of the ampoule. Break off the top of the ampoule by pressing on the mark.

Depending on the severity of the clinical picture, the initial dose is 10-20 ml intravenously or intra-arterially; further on 5 ml in / in or slowly in / m daily or several times a week.

When used as an infusion, 10-50 ml is diluted in 200-300 ml of isotonic sodium chloride solution or 5% dextrose solution (stock solutions), administration rate: about 2 ml / min.

b) Doses depending on indications:

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200-1000 mg per day) intravenously daily for two weeks, followed by the transition to a tablet form of administration.

Cerebrovascular and nutritional disorders such as ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% glucose solution, intravenously daily for 1 week, then 10-20 ml (400-800 mg) intravenously drip - 2 weeks, followed by the transition to a tablet form of administration.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800-1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% glucose solution, intra-arterially or intravenously daily; the duration of treatment is 4 weeks.

Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by the transition to a tablet form of administration - 2-3 tablets 3 times a day for at least 4-5 months.

Venous ulcers of the lower extremities: 10 ml (400 mg) IV or 5 ml IM daily or 3 to 4 times a week depending on the healing process

The duration of the course of treatment is determined individually according to the symptoms and severity of the disease.

Side effects

From the side of the immune system

    Rare: allergic reactions (drug fever, symptoms of anaphylactic shock).

Skin and subcutaneous tissue disorders

    Rare: urticaria, redness

Contraindications

    hypersensitivity to the components of the drug Actovegin®

    general contraindications to infusion therapy: decompensated heart failure, pulmonary edema, oliguria, anuria, hyperhydration

Drug Interactions

Not installed

special instructions

Intramuscularly, it is desirable to inject slowly no more than 5 ml, since the solution is hypertonic.

In view of the possibility of anaphylactic reactions, a trial injection (2 ml intramuscularly) is recommended before starting therapy.

The use of Actovegin® should be carried out under medical supervision, with appropriate facilities for the treatment of allergic reactions.

For infusion use, Actovegin®, injection, can be added to isotonic sodium chloride solution or 5% glucose solution. Aseptic conditions must be observed, since Actovegin® for injection does not contain preservatives.

From a microbiological point of view, opened ampoules and prepared solutions should be used immediately. Solutions that have not been used should be discarded.

With regard to mixing Actovegin® solution with other solutions for injection or infusion, physico-chemical incompatibility, as well as interaction between active substances, cannot be excluded, even if the solution remains optically clear. For this reason, Actovegin® solution should not be mixed with other drugs, except for those mentioned in the instructions.

The solution for injection has a yellowish tint, the intensity of which depends on the batch number and starting material, but the color of the solution does not affect the efficacy and tolerability of the drug.

Do not use an opaque solution or a solution containing particles!

Use with caution in hyperchloremia, hypernatremia.

Children

There are currently no data available and use is not recommended.

Use during pregnancy

The use of the drug Actovegin® is allowed if the expected therapeutic benefit outweighs the possible risk to the fetus.

Application during lactation

When using the drug in the human body, no negative effects on the mother or child were identified. Actovegin® should be used during lactation only if the expected therapeutic benefit outweighs the possible risk to the child.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No or minor influences.

Overdose

There is no data on the possibility of overdose with Actovegin®. Based on pharmacological data, no additional undesirable effects are expected.

Release form and packaging

Solution for injections 40 mg/ml.

2 and 5 ml of the drug in colorless glass ampoules (type I, Eur.pharm.) with a break point. 5 ampoules in a plastic blister pack. 1 or 5 blister packs with instructions for use are placed in a cardboard box. Transparent protective stickers of a round shape with holographic inscriptions and control of the first opening are pasted on the pack.

Actovegin instructions for use, indications and contraindications. In this article, you will read the instructions for use of the drug Actovegin (ACTOVEGIN®) - reviews, analogs and forms of release (tablets, injections in ampoules for injection, ointment, gel and cream) drugs for the treatment of metabolic disorders of the brain in adults, children ( newborns) and during pregnancy. ACTOVEGIN (ACTOVEGIN®) is an antihypoxant, is a hemoderivat, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons penetrate).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of the plasma membranes of cells during ischemia and a decrease in the formation of lactates), thus providing an antihypoxic effect. Actovegin increases the concentrations of ATP, ADP, phosphocreatine, as well as amino acids (glutamate, aspartate) and GABA.

Actovegin instructions for use

Actovegin is a drug that stimulates the regeneration of cells and tissues damaged due to hypoxia and metabolic disorders. Active ingredient: calf blood hemoderivat. The drug is obtained by dialysis of the blood of calves, followed by ultrafiltration.

The drug consists entirely of physiological components and includes the most important amino acids, trace elements, peptides, a moderate amount of oligosaccharides. From this medical article, you can familiarize yourself with the drug Actovegin, the instructions for use will explain in which cases you can take the medicine, what it helps with. The effect of Actovegin on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy.

Actovegin (Aktovegin): instructions for use. In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin instructions for use significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness of the lower extremities). Objectively, sensitivity disorders are reduced, the mental well-being of patients improves. The effect of Actovegin begins to appear no later than 30 minutes (10-30 minutes) after parenteral administration and reaches a maximum, on average, after 3 hours (2-6 hours).

Available in the form of a solution for injection, gels and ointments. The solution for injection is yellowish, practically free of particles. Excipients - water, sodium chloride. Also produced in tablet form, it is used as a prophylactic agent for correcting cerebral blood supply and maintaining mental activity.

Clinical and pharmacological group

A drug that activates the metabolism in tissues, improves trophism and stimulates the regeneration process. It has a pronounced antihypoxic effect, which manifests itself already half an hour after taking the drug, and reaches a maximum after 1-2 hours after using the drug. It is effective for reducing the symptoms of polyneuropathy in diabetics: it reduces pain, burning, impaired sensitivity, improves the physical and mental well-being of patients.

It is prescribed for patients with diabetes mellitus of both types to combat diabetic polyneuropathy. It has an insulin-like effect, due to which it reduces the level of glucose in the blood, delivering it to the cells of the body. It saturates the nerve cells with the necessary substances without causing a sharp drop in blood sugar levels. Patients receiving a course of Actovegin note a decrease in pain and restoration of the sensitivity of the lower extremities. Reduces the risk of diabetic foot and gangrene.

Composition (solution, injections)

Solution for infusion in solution of NaCl or dextrose:

  • Main substance: blood components (Hemoderivate deproteinized from the blood of calves 25 or 50 ml.);
  • Excipients: sodium chloride, water for injection + dextrose (for a solution with dextrose);
  • Physico-chemical properties: clear solution, colorless or slightly yellow;
  • Packing: 250 ml of solution in a glass bottle with a stopper and an aluminum cap. The bottle is placed in a cardboard box, which is protected by a transparent holographic sticker with opening control.

Injection:

  • Main substance: actovegin concentrate (calculated as Hemoderivative deproteinized from the blood of calves) 80 or 200 or 400 mg;
  • Excipients: sodium chloride, water for injection;
  • Physical and chemical properties: yellowish solution, transparent, practically devoid of particles;
  • Packaging: actovegin is produced in ampoules of 2, 5 and 10 ml with a break line. 5 ampoules in a package (contour, plastic) - 1 or 5 packs in a cardboard pack. Each pack is protected by a transparent sticker with a hologram and a tamper evident seal.

At the time of the course, it is necessary to abandon the use of alcoholic beverages, since ethanol will neutralize the entire therapeutic effect of Actovengin, and will accelerate the development of degenerative changes in the tissues of blood vessels and nerve endings. If you have vascular disease, you should stop smoking, as nicotine constricts blood vessels, disrupting the already difficult blood flow.

Composition (tablets)

  • Main substance: blood components: Hemoderivate deproteinized from the blood of calves 200 mg. (Actovegin instructions for use);
  • Excipients: Magnesium stearate, povidone, talc, cellulose. Shell: mountain glycol wax, acacia gum, hypromellose phthalate, diethyl phthalate, yellow quinoline dye, macrogol, aluminum varnish, povidone K30, talc, sucrose, titanium dioxide;
  • Physical and chemical properties: round, shiny greenish-yellow coated tablets;
  • Packing: 50 tab. in dark glass bottles, in a cardboard box.

Composition (gel 20%)

  • Main substance: hemoderivate deproteinized from the blood of calves 20 ml/100 gr.;
  • Excipients: carmellose sodium, calcium lactate, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water;
  • Physical and chemical properties: homogeneous gel, yellowish or colorless;

Composition (cream 5%)

  • Physical and chemical properties: homogeneous white cream;
  • Packing: 20, 30, 50, 100 gr in aluminum tubes, in cardboard packs.

Composition (ointment 5%)

  • Main substance: hemoderivate deproteinized from the blood of calves 5 ml/100 gr.;
  • Excipients: macrogol 400 and 4000, cetyl alcohol, benzalkonium chloride, glyceryl monostearate, purified water;
  • Physical and chemical properties: homogeneous consistency ointment, white;
  • Packing: 20, 30, 50, 100 gr in aluminum tubes, in cardboard packs.

Price

  1. Solution for infusion in p-re NaCl or dextrose. Price: 700-800 rubles;
  2. Injection. Price: 2 ml 10 pcs.: 610-690 rubles; 2 ml 25 pcs.: 1300-1500 rubles; 5 ml 5 pcs.: 500-600 rubles; 10 ml 5 pcs.: 1000-1300 rubles;
  3. Tablets. Price: 50 pcs.: 1400-1700 rubles;
  4. Gel 20%. Price: 20 gr.: 170-200 rubles;
  5. Cream 5%. Price: 20 gr.: 125-150 rubles;
  6. Ointment 5%. Price: 20 gr.: 115-140 rub.

Indications for use

  • Metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury);
  • Peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);
  • Diabetic polyneuropathy;
  • Wound healing (ulcers of various etiologies, burns, trophic disorders (pressure sores), impaired wound healing processes);
  • Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy.

Contraindications

  • Hypersensitivity to the drug Actovegin;
  • Decompensated heart failure;
  • Pulmonary edema;
  • Oliguria;
  • Anuria;
  • Hypersensitivity to similar drugs.

With caution: hyperchloremia, hypernatremia.

Side effects

  • skin hyperemia;
  • swelling;
  • Skin rash;
  • Anaphylactic shock;
  • medicinal fever;
  • Hyperthermia;
  • Hives.

Dosage

In / a, in / in (including in the form of infusion) and / m. Due to the potential for anaphylactic reactions, it is recommended that a test be performed prior to infusion. Actovegin instructions for use will help you.

  1. Metabolic and vascular disorders of the brain: from 5 ml to 25 ml (200-1000 mg) per day i / v daily for 2 weeks, followed by the transition to Actovegin in the form of tablets;
  2. Ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution, intravenously daily for 1 week, then 10-20 ml (400-800 mg) in / in drip - 2 weeks, followed by the transition to Actovegin in the form of tablets;
  3. Wound healing: 10 ml (400 mg) in / in or 5 ml / m daily or 3-4 times a week, depending on the healing process (in addition to local treatment with Actovegin in topical dosage forms);
  4. Radiation cystitis: daily 10 ml (400 mg) transurethral in combination with antibiotic therapy. The rate of administration is about 2 ml/min. The duration of the course of treatment is determined individually in accordance with the symptoms and severity of the disease;
  5. Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800-1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution, intravenously or intravenously daily; the duration of treatment is about 4 weeks;
  6. Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy: the average dose is 5 ml (200 mg) IV daily during breaks in radiation exposure;
  7. Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by the transition to Actovegin in the form of tablets - 2-3 tab. 3 times / day for at least 4-5 months.

The duration of the course of treatment is determined individually, depending on the symptoms and severity of the disease.

Release form

  • Film-coated tablets 200 mg;
  • Solution for injections (injections in ampoules) 40 mg/ml;
  • Gel for external use 20%;
  • Ointment for external use 5%;
  • Cream for external use 5%.

Pregnancy and lactation

The use of the drug in pregnant women did not cause negative effects on the mother or fetus. Actovegin instructions for use are always at hand. However, when used in pregnant women, the potential risk to the fetus must be considered.

Terms and conditions of storage

The drug should be stored out of the reach of children, in a place protected from light, at a temperature not exceeding 25 ° C. Shelf life - 5 years.

With caution, the drug is prescribed in situations where the risk of abortion is high: at the risk of placental abruption or diagnosed diabetes in the mother. In these cases, the drug is administered intravenously or intramuscularly, under the strict supervision of the attending physician.

Children with neurological lesions who were born as a result of a complicated pregnancy are prescribed Actovegin at the rate of 0.4 ml per kg of weight. Before use, a test for susceptibility to the components of the drug is carried out, the decision to prescribe and stop therapy is made by the attending physician. It is strictly forbidden to engage in self-diagnosis!

After opening the ampoule, the solution can not be stored.

Actovegin is used in violation of the patency of veins and arteries, to compensate for the lack of blood supply. The drug helps to deliver glucose and oxygen to cells, and also has a beneficial effect on the walls of blood vessels. It prevents the deposition of blood clots in both veins and arteries, restores blood flow in small vessels, tones the smooth muscles of veins and capillaries.

Actovegin instructions for use is used to treat thrombophlebitis and varicose veins, relieves swelling, prevents stretching of the walls of the veins and reduces thrombosis. Patients note a decrease in burning sensation and heaviness in the legs, the disappearance of bruising and a decrease in swelling.

special instructions

In the case of the / m method of administration, slowly inject no more than 5 ml.

Due to the possibility of an anaphylactic reaction, a trial injection (2 ml IM) is recommended.

The solution for injection has a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or its tolerability.

Do not use a solution that is opaque or contains particles. Well read Actovegin instructions for use.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Analogues

The only drug that can rightfully be called an analogue of Actovegin is Solcoseryl. This analogue is produced in the form of ointments, creams and solutions for injections. The price of the drug is from 200 rubles. Some manufacturers set a high price for Solcoseryl.

Injection

Excipients: sodium chloride, water d / i.

2 ml - colorless glass ampoules (5) - blister plastic contour packaging (1) - cardboard packs.
2 ml - colorless glass ampoules (5) - cellular contour plastic packaging (5) - cardboard packs.

Injection transparent, yellowish, practically free from particles.

Excipients: sodium chloride, water d / i.

5 ml - colorless glass ampoules (5) - cellular contour plastic packaging (1) - cardboard packs.
5 ml - colorless glass ampoules (5) - cellular contour plastic packaging (5) - cardboard packs.

Injection transparent, yellowish, practically free from particles.

Excipients: sodium chloride, water d / i.

10 ml - colorless glass ampoules (5) - blister plastic contour packaging (1) - cardboard packs.
10 ml - colorless glass ampoules (5) - cellular contour plastic packaging (5) - cardboard packs.

Excipients: sodium chloride, water d / i.

Solution for infusion (in sodium chloride solution 0.9%) transparent, colorless to slightly yellow.

Excipients: sodium chloride, water d / i.

250 ml - colorless glass bottles (1) - packs of cardboard.

Clinical and pharmacological group

A drug that activates the metabolism in tissues, improves trophism and stimulates the regeneration process

pharmachologic effect

An antihypoxant is a hemoderivat, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons penetrate).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of the plasma membranes of cells during ischemia and a decrease in the formation of lactates), thus providing an antihypoxic effect.

Actovegin ® increases the concentrations of ATP, ADP, phosphocreatine, as well as amino acids (glutamate, aspartate) and GABA.

The effect of Actovegin ® on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy.

In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin ® significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness of the lower extremities). Objectively, sensitivity disorders are reduced, the mental well-being of patients improves.

The effect of Actovegin begins to appear no later than 30 minutes (10-30 minutes) after parenteral administration and reaches a maximum, on average, after 3 hours (2-6 hours).

Pharmacokinetics

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics (absorption, distribution, excretion) of the active components of Actovegin ®, since it consists only of physiological components that are usually present in the body.

To date, no decrease in the pharmacological efficacy of hemoderivatives has been found in patients with altered pharmacokinetics (including with hepatic or renal insufficiency, metabolic changes associated with advanced age, due to the peculiarities of metabolism in newborns).

Indications for the use of the drug

- metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury);

- peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);

- diabetic polyneuropathy;

- wound healing (ulcers of various etiologies, trophic disorders / bedsores /, burns, impaired wound healing processes);

— prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy.

Dosing regimen

Injection administered in / a, in / in (including in the form of infusion) and / m. The infusion rate is about 2 ml / min.

At ischemic stroke 20-50 ml (800-2000 mg) solution for injection is diluted in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution and administered intravenously daily for 1 week, followed by the introduction of 10-20 ml (400 -800 mg) in / in drip for 2 weeks and then with the transition to taking the drug Actovegin ® in the form of tablets.

At administered intravenously from 5 to 20 ml of injection solution (200-800 mg / day) daily for 2 weeks, followed by the transition to Actovegin ® in the form of tablets.

At peripheral (arterial and venous) vascular disorders and their consequences administer 20-30 ml (800-1200 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution intravenously or intravenously daily; duration of treatment - 4 weeks.

At diabetic polyneuropathy inject 50 ml (2000 mg) per day intravenously for 3 weeks, followed by a switch to taking the drug Actovegin ® in the form of tablets - 2-3 tab. 3 times / day for at least 4-5 months.

For wound healing 10 ml (400 mg) is injected intravenously or 5 ml (200 mg) intramuscularly daily or 3-4 times a week, depending on the healing process (in addition to local therapy with Actovegin ® in dosage forms for external use).

With the aim of the average dose is 5 ml (200 mg) IV daily in the intervals between radiation exposures.

At radiation cystitis administered transurethral daily 10 ml (400 mg) in combination with antibiotic therapy. The rate of administration is about 2 ml/min.

The duration of the course of treatment is determined individually, depending on the symptoms and severity of the disease.

Solution for infusion administered in / in drip or in / a jet. The infusion rate is about 2 ml / min.

The duration of the course of treatment is determined individually, depending on the symptoms and severity of the disease.

At ischemic stroke 250-500 ml (1000-2000 mg) per day is administered intravenously for 2 weeks, followed by a switch to taking the drug Actovegin ® in the form of tablets.

At metabolic and vascular disorders of the brain at the beginning of treatment - 250-500 ml (1000-2000 mg) per day intravenously for 2 weeks, followed by a switch to taking the drug Actovegin ® in the form of tablets.

At peripheral vascular disorders and their consequences introduce 250 ml (1000 mg) intravenously or intravenously, daily or several times a week, followed by switching to taking the drug Actovegin ® in the form of tablets.

At diabetic polyneuropathy administer 250 ml (2000 mg; 8 mg/ml) or 500 ml (2000 mg; 4 mg/ml) per day intravenously for 3 weeks, followed by switching to taking the drug Actovegin ® in the form of tablets - 2-3 tab. 3 times / day for at least 4-5 months.

For wound healing administer 250 ml (1000 mg) IV daily or several times a week, depending on the rate of healing. Perhaps joint use with Actovegin in dosage forms for external use.

For prevention and treatment of radiation injuries of the skin and mucous membranes on average, 250 ml (1000 mg) is administered intravenously the day before and daily during radiation therapy, as well as within 2 weeks after its completion, followed by the transition to taking the drug Actovegin ® in the form of tablets - 2-3 tab. 3 times / day for at least 4-5 months.

Side effect

Allergic reactions: skin rash, skin hyperemia, hyperthermia, up to anaphylactic shock.

Contraindications to the use of the drug

- decompensated heart failure;

- pulmonary edema;

- oliguria;

- anuria;

- fluid retention in the body;

- hypersensitivity to the components of the drug;

- Hypersensitivity to similar drugs.

WITH caution the drug should be prescribed for hyperchloremia, hypernatremia.

The use of the drug during pregnancy and lactation

The use of the drug during pregnancy did not adversely affect the mother or fetus, however, if necessary, the use of the drug during pregnancy should take into account the potential risk to the fetus.

Application for violations of kidney function

WITH caution the drug should be prescribed for oliguria, anuria.

special instructions

In connection with the potential for the development of anaphylactic reactions, it is recommended to conduct a test (trial injection of 2 ml / m) before infusion.

In the case of the / m method of administration, the drug should be administered slowly in an amount of not more than 5 ml.

Solutions of Actovegin have a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not affect the effectiveness and tolerability of the drug.

Do not use an opaque solution or a solution containing particles.

After opening the ampoule or vial, the solution cannot be stored.

Overdose

Information about an overdose of the drug Actovegin ® is not provided.

drug interaction

Drug interaction of the drug Actovegin ® has not been established.

However, in order to avoid possible pharmaceutical incompatibility, it is not recommended to add other drugs to Actovegin infusion solution.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 25°C. Shelf life - 5 years.

active substance: 1 ml of the drug contains deproteinized hemoderivat from the blood of calves, corresponds to 40 mg of dry weight;

Excipients: sodium chloride, water for injection.

Dosage form

Injection.

Basic physical and chemical properties: yellowish solution.

Pharmacotherapeutic group

Drugs affecting the digestive system and metabolic processes. ATX code A16A X.

Pharmacological properties

Pharmacodynamics.

The drug Actovegin is a deproteinized hemoderivative from the blood of calves, it contains only physiological substances with a molecular weight of less than 5000 daltons. The action of the drug is manifested by neuroprotective and metabolic effects. Neuroprotective effects are provided by a decrease in the juvenile effect of oxidative stress and a decrease in neuronal apoptosis. Metabolic effects are non-organ specific. At the molecular level, Actovegin accelerates the processes of oxygen utilization (increases resistance to hypoxia) and glucose, thereby helping to increase energy metabolism. The overall effect of these processes is to enhance the energy state of the cell, especially under conditions of hypoxia and ischemia. The effect of Actovegin on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy.

In patients with type 2 diabetes mellitus and diabetic polyneuropathy, Actovegin reduces the intensity of symptoms of diabetic polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness in the lower extremities). Reduces violations of vibration sensitivity and improves the quality of life of patients.

Pharmacokinetics.

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics of Actovegin (absorption, distribution and elimination of active ingredients), since it consists only of physiological components that are usually present in the body.

Indications

  • Diseases of the brain of vascular and metabolic origin (including dementia).
  • Peripheral (arterial, venous) circulation disorders and their complications (arterial angiopathy, venous trophic ulcer).
  • Diabetic polyneuropathy (DPN).

Contraindications

Hypersensitivity to any components of the drug or to drugs of a similar composition. Decompensated heart failure, pulmonary edema, oliguria, anuria are common contraindications to infusion therapy, therefore, the administration of the drug in the form of infusions in these conditions is contraindicated due to possible overhydration.

Interaction with other medicinal products and other forms of interaction

There are no data on the interaction of Actovegin with other drugs.

Application features

Intramuscularly, it is desirable to inject no more than 5 ml, since the solution is hypertonic.

Solution for injection is compatible with 0.9% sodium chloride solution and 5% glucose solution.

The drug Actovegin, solution for injection, should be used under sterile conditions. Since the drug does not contain preservatives, the contents of the ampoule are intended for single use. Opened ampoules and ready solution should be used immediately. Unused product and waste must be disposed of in accordance with local regulations.

Due to the possibility of anaphylactic reactions, a test injection (hypersensitivity test) is recommended. In case of development of violations of water and electrolyte metabolism (for example, hyperchloremia, hypernatremia), it is necessary to carry out an appropriate correction.

The solution for injection has a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or sensitivity to it.

Only a clear solution without visible particles can be used.

The solution contains sodium. This should be considered in patients who are on a controlled sodium diet.

Use during pregnancy or lactation.

The drug should be used during pregnancy or lactation only when the expected benefit to the mother outweighs the possible risk to the fetus or child. During the use of the drug Actovegin in placental insufficiency, although rarely, fatal cases were observed, which could be a consequence of the underlying disease. The use of the drug Actovegin during breastfeeding was not accompanied by negative effects either for the mother or for the child.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Actovegin has no or very little effect on the reaction rate when driving vehicles or operating other mechanisms. However, possible manifestations of side effects from the nervous system should be taken into account (see section "Adverse reactions").

Dosage and administration

Actovegin, solution for injection, apply intravenously (stream, drip), intra-arterially, 5-20 ml per day.

Intramuscularly injected slowly, no more than 5 ml per day.

For intravenous administration, dilute the drug in 0.9% sodium chloride solution or 5% glucose solution. The final concentration of Actovegin is allowed - up to 2000 mg of dry matter per 250 ml of solution.

given the clinical symptoms, first administer 5-10 ml intravenously or intraarterially, then 5 ml intravenously or slowly intramuscularly daily or several times a week;

b) doses depending on the indications for use:

For severe conditions

Intravenously drip inject 20-50 ml / day of Actovegin for several days until a pronounced clinical effect is achieved.

Condition of moderate severity or exacerbation of chronic diseases

5-20 ml / day intravenously or intramuscularly for 14-17 days.

The course of planned treatment

2-5 ml / day intravenously or intramuscularly for 4-6 weeks.

The number of injections - from 1 to 3 times, depending on the severity.

With diabetic polyneuropathy

Treatment begins with intravenous use of the drug at a dose of 2 g per day for 3 weeks, followed by the transition to tablets - 2-3 tablets 3 times a day for at least 4-5 months.

Children. There are no data on the use of the drug in children, so the drug is not recommended for use in this category of patients.

Overdose

Cases of overdose with Actovegin are unknown.

Adverse reactions

The following describes the adverse reactions that may occur in patients as a result of the use of the drug Actovegin. Anaphylactic (allergic) reactions may occur, which can manifest themselves:

from the immune system and skin- possible hypersensitivity reactions, including allergic reactions, anaphylactic and anaphylactoid reactions up to the development of anaphylactic shock, fever, chills, angioedema, skin flushing, skin rashes, itching, urticaria, increased sweating, swelling of the skin and / or mucous membranes, hot flashes fever, changes at the injection site;

from the digestive tract- dyspeptic phenomena, including pain in the epigastric region, nausea, vomiting, diarrhea;

from the cardiovascular system- pain in the region of the heart, increased heart rate (tachycardia), shortness of breath, acrocyanosis, pale skin, arterial hypotension or hypertension;

from the respiratory system- rapid breathing, a feeling of constriction in the chest, difficulty swallowing and / or breathing, sore throat, choking attack;

from the nervous system- headache, general weakness, dizziness, loss of consciousness, agitation, trembling (tremor), paresthesia;

from the musculoskeletal system- pain in the muscles and / or joints, pain in the lower back.

In such cases, treatment with Actovegin should be discontinued and symptomatic therapy applied.

Best before date

Storage conditions

Store below 25°C in original packaging. Keep out of the reach of children!

Incompatibility

The drug should not be mixed in the same container with other solutions, with the exception of those indicated in the section "Method of application and doses".

Package

2 ml per ampoule, 25 ampoules per carton.

5 ml in an ampoule; 5 ampoules in a carton box

10 ml in an ampoule; 5 ampoules in a cardboard box.

Holiday category

On prescription.

Manufacturer

LLC "Kusum Pharm", Ukraine / LLC "Kusum Pharm", Ukraine.

(packaging from in-bulk form by Takeda Austria GmbH, Austria)/(packaging of in-bulk by Takeda Austria GmbH, Austria).

Location of the manufacturer and its address of the place of business

st. Skryabina, 54, m. Sumy, Sumy region, 40020, Ukraine/54, Skryabina str., Sumy, Sumy region, 40020, Ukraine.