Active substanceDeproteinized hemoderivatDeproteinized hemoderivat
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    Nycomed Austria GmbH     Austria
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  • Dosage form: & nbspsolution for infusions [in sodium chloride solution 0,9%]
    Composition:

    250 ml of solution contains:

    active substance: blood components - deproteinized hemoderivat of calves' blood:

    - dosage of 4 mg / ml: 25 ml (corresponding to 1 g of dry mass),

    - dosage of 8 mg / ml: 50 ml (corresponding to 2 g of dry mass);

    auxiliary substances: sodium chloride, water for injection.

    Description:Transparent, from a colorless to slightly yellow 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). 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 (DPN).

    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.

    Pharmacokinetics:

    With the help of pharmacokinetic methods it is impossible to study the pharmacokinetic indices 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 advanced age, and metabolic peculiarities in newborns).

    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, uncompensated 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:

    Ischemic stroke: 250 - 500 ml (1000 - 2000 mg) per day intravenously for 2 weeks with the subsequent transition to the tablet form.

    Metabolic and vascular disorders of the brain: in the beginning - 250-500 ml (1000 - 2000 mg) per day intravenously for 2 weeks with the subsequent transition to the tablet form.

    Peripheral vascular disorders and their consequences: 250 ml (1000 mg) intraarterially or intravenously, daily or several times a week, followed by a transition to a tablet form.

    Diabetic polyneuropathy: 2000 mg (250 ml (8 mg / ml)) or 500 ml (4 mg / ml)) 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: 250 ml (1000 mg) intravenously, daily or several times a week, depending on the speed of healing. It is possible to use together with the medicinal forms of ACTOVEGIN® for external use.

    Prevention and treatment of radiation injuries of the skin and mucous membranes: on average 250 ml (1000 mg) intravenously the day before and every day during radiation therapy, and also within 2 weeks after its termination, with the subsequent transition to the tablet form.

    Rate of administration: about 2 ml / min.

    In connection with the potential for the development of anaphylactic reactions, it is recommended to test for hypersensitivity to the drug before the infusion. 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.

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

    Special instructions:

    With multiple administrations, the water-electrolyte balance of the blood plasma should be monitored.

    The infusion solution 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 vial, the solution should not be stored.

    Form release / dosage:Solution for infusions [in sodium chloride solution 0,9%] 4 mg / ml, 8 mg / ml.
    Packaging:

    To 250 ml in a bottle for infusions of colorless glass (Eur.Pharm., Type II), sealed with a stopper and an aluminum cap for running in, top covered with a lid, providing control of the first opening.

    1 bottle together with the instruction for use is 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 / 01
    Date of registration:26.02.2008 / 29.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:NIKOMED DISTRIBUTION Sente, LLC NIKOMED DISTRIBUTION Sente, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
    Information update date: & nbsp29.06.2017
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