Actovegin injection instructions

Actovegin injection solution - official instructions for use


Registration number:

LS-001323

Trade name of the preparation:

Actovegin®

Group name

Calcium deproteinized hemoderivative

Dosage form:

injection

Composition

For 2 ml ampoules:

1 ampoule contains:

active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderivative of calf blood) * - 80.0 mg;

excipient: water for injection - up to 2 ml.

For 5 ml ampoules:

1 ampoule contains:

active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderivative of calf blood) * - 200.0 mg;

excipient: water for injection - up to 5 ml.

For 10 ml ampoules:

1 ampoule contains:

active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderivative of calf blood) * - 400.0 mg;

excipient: water for injection - up to 10 ml.

* Actovegin® concentrate contains sodium chloride in the form of sodium and chlorine ions, which are components of calf blood. Sodium chloride is not added or removed during the production of the concentrate. The sodium chloride content is about 53.6 mg (for ampoules 2 ml), about 134.0 mg (for ampoules 5 ml) and about 268.0 mg (for ampoules 10 ml).

Description:

clear yellowish solution

Pharmacotherapeutic group:

tissue regeneration stimulator

ATX Code:

B06AB

Pharmachologic effect

Pharmacodynamics

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

It positively affects 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 lactate), thus possessing an antihypoxic effect that begins to appear at the latest 30 minutes after parenteral administration and reaches a maximum on average after 3 hours (2-6 hours). Actovegin® increases the concentration of adenosine triphosphate, adenosine diphosphate, phosphocreatine, as well as amino acids - glutamate, aspartate and gamma-aminobutyric acid.

The effect of Actovegin® on the absorption and utilization of oxygen, as well as insulin-like activity with stimulation of transport and oxidation of glucose, are significant in the treatment of diabetic polyneuropathy (DPN). In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin® significantly reduces the symptoms of polyneuropathy (stitching, burning sensation, parasthesia, numbness in the lower extremities) Sensory disorders are objectively reduced, and patients' mental well-being improves.

Pharmacokinetics

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic parameters of Actovegin®, since it consists only of the physiological components that are usually present in the body.

To date, there has been no decrease in the pharmacological effect of hemoderivatives in patients with altered pharmacokinetics (for example, hepatic or renal failure, changes in metabolism associated with advanced age, as well as metabolic features in newborns)

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

Contraindications

Hypersensitivity to Actovegin® or similar drugs, decompensated heart failure, pulmonary edema, oliguria, anuria, fluid retention in the body.

Precautions: hyperchloremia, hypernatremia

Pregnancy and lactation:

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

Dosage and administration

Intraarterially, intravenously (including in the form of infusion) and intramuscularly. 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 the start of the infusion.

Instructions for using ampoules with a break point:

Picture 1

Place the tip of the ampoule point up! Gently tapping with a finger and shaking the ampoule, allow the solution to drain down from the tip of the ampoule.

Picture 2

Position the tip of the ampoule point up! Break off the tip as pictured.

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

When administered in the form of an infusion, 10-20 ml of ACTOVEGIN © is added to 200-300 ml of the basic solution (0.9% sodium chloride solution or 5% dextrose solution). Speed ​​of administration: about 2 ml / min. For intramuscular injections, use no more than 5 ml of the drug, which should be enter slowly, since the solution is hypertonic.

Metabolic and vascular disorders of the brain: 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 the main solution intravenously drip daily for 1 week, then 10-20 ml intravenously drip - 2 weeks.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml of the drug in 200 ml of the main solution intraarterially or intravenously daily; the duration of treatment is 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 topical treatment with ACTOVEGIN © in topical dosage forms).

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

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

Side effects

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

Interaction with other drugs

Currently unknown.

Special instructions

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

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

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

After opening the ampoule, the solution cannot be stored.

Release form

Injection 40 mg / ml.

2, 5, 10 ml of the drug in colorless glass ampoules (type I, Heb. Pharm.) With a break point. 5 ampoules per plastic blister strip packaging. 1 or 5 blister packs with instructions for use are placed in a cardboard box. Transparent round protective stickers with holographic inscriptions and first opening control are glued onto the pack.

Shelf life

5 years. Do not use after expiration date.

Storage conditions

At a temperature not exceeding 25 ° C in a dark place. Keep out of the reach of children!

Release conditions

Prescription.

Manufacturer

Nycomed Austria GmbH, Austria

Art. Peter Strasse 25, A-4020 Linz, Austria

"Nycomed Austria GmbH", Austria

St. Peter Strasse 25, A-4020 Linz, Austria

Claims of consumers should be sent to:

Limited liability company "Takeda Pharmaceuticals" (LLC "Takeda Pharmaceuticals")

February 24, 2017


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