Actovegin - instructions for use, dose, side effects, contraindications

For ampoules of 2 ml: 1 ampoule contains: active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderate of calves' blood)¹⁾ - 80.0 mg; auxiliary substance: water for injection - up to 2 ml.

For ampoules of 5 ml: 1 ampoule contains: active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderate of calves' blood)¹⁾ 200.0 mg; auxiliary substance: water for injection - up to 5 ml.

For 10 ml ampoules: 1 ampoule contains: active substance: Actovegin® concentrate (in terms of dry deproteinized hemoderate of calves' blood)¹⁾ 400.0 mg; auxiliary substance: water for injection - up to 10 ml.

¹⁾ In the concentrate Actovegin® is present sodium chloride in the form of sodium and chlorine ions, which are components of the blood of calves. Sodium chloride is not added and is not 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 10 ml ampoules).

Description:

Transparent yellowish solution.

Pharmacotherapeutic group:regeneration of tissue stimulant

ATX: & nbsp

Other hematological preparations

Pharmacodynamics:

Antihypoxant.

Actovegin® is a hemoderivat, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5,000 daltons pass through). Stimulates transport and utilization of glucose.Increases the uptake and utilization of oxygen (which leads to stabilization of plasma cell membranes in ischemia and reduced lactate formation). Thus, Actovegin® has an antihypoxic effect, which 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 concentrations of adenosine triphosphate, adenosine diphosphate, creatine phosphate, as well as amino acids - glutamate, aspartate and gamma-aminobutyric acid.

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

In patients with diabetes and diabetic polyneuropathy, Actovegin® reduces symptoms of polyneuropathy (stitching, burning sensation, parasthesia, numbness in the lower extremities).

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

Pharmacokinetics:

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

To date, there has been no reduction in the pharmacological effect of hemoderovatives in patients with altered pharmacokinetics (eg, hepatic or renal insufficiency, metabolic changes associated with old age, and metabolic features in neonates).

Indications:

It is used as part of complex therapy with the following conditions:

- metabolic and cerebral disorders of the brain (including ischemic stroke, craniocerebral 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), disturbance of wound healing processes);

- prevention and treatment of radiation injuries of the skin and mucous membranes with radiation therapy.

Contraindications:

Hypersensitivity to the drug Actovegin® or similar drugs, decompensated heart failure, pulmonary edema, oliguria, anuria, hyperhydration.

Carefully:

Hyperchloremia, hypernatremia.

Pregnancy and lactation:

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

During pregnancy and during breastfeeding the drug is prescribed at the existing indications in dosages: 200-400 mg intravenously drip in 200 ml of sodium chloride solution 0.9% for 7-10 days, followed by transition to the tablet form of 1 tablet (200 mg) 3 times a day for 2-4 weeks.

Dosing and Administration:

Intravenous (including infusion), intramuscularly, intraarterially.

The rate of administration: slowly, about 2 ml / min.

In connection with the potential for the development of anaphylactic reactions, it is recommended to carry out an allergological test, namely: 2 ml intramuscularly.

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

Instructions for the use of ampoules with a break point:

a) place the tip of the ampoule point to the top!

b) gently tapping and shaking the ampoule, letting the solution from the tip of the ampoule drain down;

c) break off the tip of the ampoule.

Metabolic and cerebral disorders of the brain: from 5 to 25 ml (200-1000 mg per day) intravenously every day for two weeks, with the subsequent transition to a tablet form of administration.

Ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml of 0.9% solution of sodium chloride or 5% glucose solution, intravenously drip daily for 1 week, then 10-20 ml (400-800 mg) intravenously drip - 2 weeks with the subsequent transition to the tablet form of reception.

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

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

Healing Wounds: 10 ml (400 mg) 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 topical dosage forms).

Prophylaxis and treatment of radiation lesions of the skin and mucous membranes with radiation therapy: the average dose is 5 ml (200 mg) intravenously daily in the interruption of radiation exposure, radiation cystitis: daily 10 ml (400 mg) of transurethral combined with antibiotic therapy.

Side effects:

Allergic reactions (eg, urticaria, swelling, hyperthermia) until anaphylactic shock.

Overdose:

Currently, data on drug overdose are limited.

Treatment for overdose: symptomatic therapy.

Interaction:

Currently, data on interactions with other drugs are limited.

Special instructions:

Because of the possibility of an anaphylactic reaction, a trial injection (2 ml intramuscularly) is recommended.

In the case of intramuscular administration, slowly inject no more than 5 ml. It is necessary to comply with aseptic conditions, since Actovegin® for injections does not contain preservatives.

Solution for injection has a slightly yellowish tinge. The color intensity can vary from one batch to another, depending on the nature of the raw materials used, but this does not adversely affect the activity of the drug or its tolerability.

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

Effect on the ability to drive transp. cf. and fur:

There are no data on the effect on the ability to drive vehicles and mechanisms.

Form release / dosage:

Solution for injection, 40 mg / ml.

Packaging:

In the case of production and packaging at Takeda Austria GmbH, Austria:

To 2, 5, 10 ml of the drug in colorless glass ampoules with a break point. 5 ampoules are placed in a plastic outline cell packing. For 1, 2 or 5 contour squares with instructions for use are placed in a pack of cardboard. On the pack are glued transparent protective labels of a round shape with holographic inscriptions and the control of the first autopsy.

In the case of production and / or packaging at OOO Takeda Pharmaceuticals, Russia:

To 2, 5, 10 ml of the drug in colorless glass ampoules with a break point. 5 ampoules are placed in a plastic contour mesh box made of a polystyrene film or a polyvinylchloride film. For 1,2 or 5 contour squares with instructions for use put in a pack of cardboard. On the pack are glued transparent protective labels of a round shape with holographic inscriptions and the control of the first autopsy.

Storage conditions:

At a temperature of 18-25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001323

Date of registration:26.02.2006 / 15.07.2016

Expiration Date:Unlimited

The owner of the registration certificate:Takeda Pharmaceuticals, LLCTakeda Pharmaceuticals, LLC Russia

Manufacturer: & nbsp

TAKEDA AUSTRIA GmbH Austria

Takeda Pharmaceuticals, LLC Russia

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp06.10.2016

Illustrated instructions

Instructions

Actovegin® (Actovegin®)