Actovegin, 40 mg/ml 5 ml 5 pcs

Pharmacotherapeutic group:

Tissue regeneration stimulator

ATC code:

B06AB

Pharmacological action

Pharmacodynamics

Antihypoxant. Actovegin® is a hemoderivative which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons pass through).

Positive effects on glucose transport and utilization, stimulates oxygen consumption (which leads to stabilization of plasma cell membranes during ischemia and reduction of lactate formation) thus possessing an anti-hypoxic effect, which starts manifesting itself 30 minutes after parenteral administration at the latest and reaches a maximum in 3 hours (2-6h) on average. Aktovegin® increases concentrations of adenosine triphosphate, adenosine diphosphate, phosphocreatine as well as amino acids – glutamate, aspartate and gamma-aminobutyric acid.

The effects 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® reliably decreases symptoms of polyneuropathy (stabbing pain, burning sensation, parasthesias, numbness in lower extremities).

Pharmacokinetics

Pharmacokinetic methods cannot be used to study the pharmacokinetics of Actovegin® because it consists only of physiological components that are normally present in the body.

To date no decrease in the pharmacological effect of hemoderivatives has been found in patients with altered pharmacokinetics (e.g., hepatic or renal insufficiency, metabolic changes associated with advanced age, and metabolic features in newborns)

Indications

Dizziness, Tinnitus, Trophic ulcers, Wounds, Acquired dementia, Burns, Bedsores, Stroke sequelae, Headache, Impaired cerebral circulation, Concussion and other brain injuries

• Metabolic and vascular disorders of the brain (including ischemic stroke craniocerebral trauma).
• Peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers); diabetic polyneuropathy
• Wound healing (ulcers of various etiology, burns, trophic disorders (bedsores) disruption of wound healing).
• Prevention and treatment of radiation lesions of the skin and mucous membranes in radiation therapy

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Active ingredient

Deproteinized calf blood hemoderivative

Composition

1 ampoule contains:

the active ingredient:

Actovegin® concentrate (in terms of dry deproteinized calf blood hemoderivate)1) – 200.0 mg;

auxiliary substance:

water for injection – up to 5 ml.

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How to take, the dosage

Depending on the severity of the clinical picture, the initial dose is 10-20 ml/day intravenously or intraarterially; then 5 ml intravenously or 5 ml intramuscularly.

Metabolic and vascular brain disorders: at the beginning of treatment 10 ml intravenously daily for two weeks, then 5-10 ml intravenously 3-4 times a week for at least 2 weeks.

Ischemic stroke: 20-50 ml in 200-300 ml of basic solution by intravenous drip daily for 1 week, then 10-20 ml by intravenous drip for 2 weeks.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml of the drug in 200 ml of the basic solution intra-arterially or intravenously daily; duration of treatment about 4 weeks.

Wound healing: 10 ml intravenously or 5 ml intramuscularly daily or 3-4 times a week depending on the healing process (in addition to local treatment with Actovegin in dosage forms for local use).

Prevention and treatment of radiation lesions of the skin and mucous membranes in radiation therapy: the average dose is 5 ml intravenously daily during the breaks of radiation exposure.

Radiation cystitis: 10 ml transurethral daily in combination with antibiotic therapy.

Interaction

It is currently unknown.

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

Special Instructions

The plasma water-electrolyte balance should be monitored when administering the infusion solution repeatedly.

The infusion solution and the solution for injection have a slightly yellowish tint. The intensity of the coloration may vary from batch to batch 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. Once the vial (ampoule) has been opened, the solution should not be stored.

If the drug is used by injection, it should be administered slowly, not more than 5 ml. Because of the possibility of anaphylactic reaction it is recommended to make a test injection (2 ml in m/m).

Contraindications

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

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Side effects

Allergic reactions:

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

Pregnancy use

The use of the drug in pregnant women has not caused adverse effects on the mother or fetus.

But the potential risk to the fetus must be considered when using in pregnant women.