Actovegin, 40 mg/ml 2 ml 25 pcs

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

Positively affects glucose transport and utilization, stimulates oxygen consumption (which leads to stabilization of plasma cell membranes during ischemia and reduction of lactate formation) and thus has an antihypoxic effect, which begins to appear within 30 minutes after oral administration and reaches a maximum in average 3 hours (2-6 hours).

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

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 DPN, Actovegin® significantly reduces symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesias, and numbness in the lower extremities).

The sensory disturbances are objectively reduced and patients’ mental well-being is improved.

Indications

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

• metabolic and vascular brain disorders (including ischemic stroke, craniocerebral trauma);
• peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);
• Wound healing (ulcers of various etiology, trophic disorders / pressure sores/, burns, wound healing disorders);
• 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) – 80.0 mg;

auxiliary substance:

water for injection – up to 2 ml.

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How to take, the dosage

The solution for injection is administered by/a, intravenous (also as an infusion) and intravenous/m.

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

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

In case of metabolic and vascular disorders of the brain treatment is started with daily IV administration of 10 ml of the solution for injection for 2 weeks, then 5-10 ml IV 3-4 times a week for at least 2 weeks.

In case of ischemic stroke 20-50 ml are diluted in 200-300 ml of infusion solution and administered by IV drop daily for 1 week with further administration of 10-20 ml by IV drop for 2 weeks.

In case of peripheral (arterial and venous) vascular disorders and their consequences 20-30 ml of the drug in 200 ml of infusion solution are administered w/a or v/v daily; treatment duration about 4 weeks.

For wound healing 10 ml v/v or 5 ml v/m daily or 3-4 times a week depending on the healing process (in addition to local therapy with Actovegin).

In order to prevent and treat radiation lesions of the skin and mucous membranes the drug is administered on average 5 ml in v/v daily in intervals between radiation exposures.

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

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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 a solution that is opaque or contains 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.

Overdose

There is no information on overdose of Actovegin.

Pregnancy use

The use of Actovegin in pregnancy has not had adverse effects on the mother or fetus, but the potential risk to the fetus should be considered if the drug must be used in pregnancy.