Actovegin 40 mg/ml 25 vials

Takeda GmbH, Germany

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Product Overview

Composition

1 ampoule contains:


active substance:

Actovegin® concentrate (in terms of dry deproteinized hemoderivat of calf blood) 1) - 80.0 mg;

excipient:

water for injection - up to 2 ml.

pharmachologic effect

Actovegin is an antihypoxant. Actovegin® is a hemoderivat that 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 the stabilization of plasma membranes of cells during ischemia and a decrease in the formation of lactate), thus has an antihypoxic effect, which begins to manifest itself at the latest 30 minutes after oral administration and reaches a maximum in on average after 3 hours (2–6 hours).

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

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

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

Disorders of sensitivity are objectively reduced, the mental well-being of patients improves.

Indications

 

  • 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);
  • wound healing (ulcers of various etiologies, trophic disorders / bedsores /, burns, impaired wound healing processes);
  • prevention and treatment of radiation injuries of the skin and mucous membranes during radiation therapy.

 

Application during pregnancy and lactation

 

The use of Actovegin during pregnancy did not have a negative effect on the mother or fetus, however, if it is necessary to use the drug during pregnancy, the potential risk to the fetus should be taken into account.

 

Contraindications

  • hypersensitivity to Actovegin® or similar drugs.
  • decompensated heart failure;
  • pulmonary edema;
  • oliguria;
  • anuria;
  • fluid retention in the body.

Side effects

Allergic reactions:

  • skin rash;
  • hyperemia of the skin;
  • hyperthermia, up to anaphylactic shock.

Interaction

It is currently unknown.

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

How to take, course of administration and dosage

 

Solution for injection is administered intravenously, intravenously (including in the form of infusion) and intramuscularly.

Depending on the severity of the clinical picture, the initial dose is 10-20 ml / i / v or i / a, then 5 ml i / v or 5 ml i / m is administered daily or several times a week.

When administered in the form of an infusion, 10-20 ml of Actovegin is added to 200-300 ml of an infusion solution (isotonic sodium chloride solution or 5% dextrose solution). The injection rate is about 2 ml / min.

With metabolic and vascular disorders of the brain, treatment begins with daily intravenous administration of 10 ml of solution for injection for 2 weeks, then 5-10 ml is administered intravenously 3-4 times a week for at least 2 weeks.

 
In ischemic stroke, 20-50 ml is diluted in 200-300 ml of infusion solution and injected intravenously by drip daily for 1 week, followed by 10-20 ml intravenous drip for 2 weeks.

In case of peripheral (arterial and venous) vascular disorders and their consequences, 20-30 ml of the drug is administered in 200 ml of an infusion solution intravenously or intravenously daily; the duration of treatment is about 4 weeks.

For wound healing, 10 ml intravenous or 5 ml intramuscularly are administered daily or 3-4 times a week, depending on the healing process (in addition to local therapy with Actovegin).

For the purpose of prevention and treatment of radiation damage to the skin and mucous membranes, an average of 5 ml intravenously is injected daily in the intervals between radiation exposure.

In case of radiation cystitis, 10 ml is administered transurethrally daily in combination with antibiotic therapy.

 

Overdose

 

Information about an overdose of Actovegin was not provided.

 

Special instructions

With multiple 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 tolerance.

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

In the case of the intramuscular route of administration, the drug is administered slowly, no more than 5 ml. Due to the possibility of an anaphylactic reaction, it is recommended to carry out a test injection (2 ml / m).

Release form

Injection

Storage conditions

In the dark place at a temperature of 18-25 ° C

Shelf life

2 years

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