Active substanceDeproteinized hemoderivatDeproteinized hemoderivat
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  • Actovegin®
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    Nycomed Austria GmbH     Austria
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  • Dosage form: & nbspsolution for infusions [in a solution of dextrose]
    Composition:

    250 ml of solution contains:

    active substance: blood components - deproteinized hemoderivat of calves' blood: 25 ml (corresponding to 1 g of dry mass);

    Excipients: dextrose, 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 positively influences the transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of plasma cell membranes in ischemia and a decrease in the formation of lactates), 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.

    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).

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

    - Prevention 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, diabetes mellitus (1 vial contains 7.75 g of dextrose).
    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:

    Intravenous drip or intra-arterial spray. For 250-500 ml per day. The infusion rate should be about 2 ml / min. Duration of treatment 10-20 infusions. In connection with the potential for the development of anaphylactic reactions, it is recommended to perform the test before the infusion.

    Metabolic and vascular disorders of the brain: in the beginning - 250-500 ml / day intravenously for 2 weeks, then - 250 ml intravenously several times a week.

    Peripheral vascular disorders and their consequences: 250 ml intraarterially or intravenously, daily or several times a week.

    Healing of wounds: 250 ml intravenously, daily or several times a week, depending on the speed of healing. It is possible to share with ACTOVEGIN® in the form of topical medications. Prophylaxis and treatment of radiation lesions of coes and mucous membranes: an average of 250 ml intravenously the day before and every day during radiation therapy, and also within 2 weeks after its termination.

    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 a solution of dextrose] 4 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:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014635 / 02
    Date of registration:14.03.2008 / 18.05.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Nycomed Austria GmbHNycomed Austria GmbH Austria
    Manufacturer: & nbsp
    Information update date: & nbsp29.06.2017
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