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

1 ampoule (2 ml) contains as active ingredient Actovegin concentrate (in terms of dry deproteinized hemoderivat of calves blood) - 80 mg; auxiliary substances: sodium chloride -53.6 mg, water for injection - up to 2 ml.

1 ampoule (5 ml) contains as active ingredient Actovegin concentrate (in terms of dry deproteinized hemoderivat blood of calves) - 200 mg; auxiliary substances: sodium chloride -134 mg, water for injection - up to 5 ml.

1 ampoule (10 ml) contains as active ingredient Actovegin concentrate (in terms of dry deproteinized blood calves calves) - 400 mg; auxiliary substances: sodium chloride-268 mg, water for injection - up to 10 ml.

Description:Transparent, yellowish solution, practically free of particles.

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). It has a positive effect on transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of plasma cell membranes in ischemia and decreased lactate formation), thus having 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 concentrations of adenosine triphosphate, adenosine diphosphate, phosphocreatine, 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 (DIN).

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

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

Indications:

Metabolic and vascular disorders of the brain (including ischemic stroke, craniocerebral injury).

Peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers); diabetic polyneuropathy.

Healing of wounds (ulcers of various etiologies, burns, trophic disorders (bedsores), disturbance of wound healing processes).

Prophylaxis and treatment of radiation lesions 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, fluid retention in the body.

Carefully:Hyperchloremia, hypernatremia.

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

Dosing 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 hypersensitivity to the drug before the infusion. Instructions for the use of ampoules with a break point:

Place the tip of the ampoule point to the top! Gently tapping your finger and shaking the ampoule, letting the solution from the tip of the ampoule drain down.

Place the tip of the ampoule point to the top! Break off the tip, as shown in the picture.

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200-1000 mg per day) intravenously daily for two weeks, followed by a transition to a tablet form.

Ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml of 0.9% solution of sodium chloride or 5% solution of dextrose, 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.

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% solution of dextrose, 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 - 2-3 tablets 3 times a day for at least 4-5 months.

Healing of 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 topical treatment with ACTOVEGIN® in topical dosage forms).

Prevention 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.

Rate of administration: about 2 ml / min.

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

Side effects:Allergic reactions (skin rash, skin hyperemia, hyperthermia) up to anaphylactic shock.

Interaction:It is currently unknown.

Special instructions:

In the case of intramuscular administration, slowly inject no more than 5 ml.

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

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.

Do not use an opaque solution or solution containing particles.

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

Form release / dosage:Solution for injection 40 mg / ml.

Packaging:To 2, 5, 10 ml of the drug in colorless glass ampoules (type I, Hebrew farm.) With a break point.5 ampoules per plastic contour mesh package. For 1 or 5 contour squares with instructions for use are placed in a cardboard box. 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 no higher than 25 ° C in a dark place.

Keep out of the reach of children!

Shelf life:5 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N014635 / 04

Date of registration:19.12.2007

Expiration Date:Unlimited

The owner of the registration certificate:Nycomed Austria GmbHNycomed Austria GmbH Austria

Manufacturer: & nbsp

NYCOMED AUSTRIA, GmbH Austria

Representation: & nbspNycomed Austria GmbHNycomed Austria GmbH

Information update date: & nbsp29.06.2017

Illustrated instructions

Instructions

Actovegin (Actovegin)