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Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
Composition:

1 bottle contains:

active substance: arglabin 40 mg;

Excipients: no.

Description:

Powder or porous mass, from white to white with a slightly yellowish hue of color.

Pharmacotherapeutic group:Antitumor agent
ATX: & nbsp
  • Other antineoplastic agents
  • Pharmacodynamics:

    Arglabin is a biologically active sesquiterpene lactone, isolated from wormwood smooth Artemisia glabella.

    Has antitumor and radiosensitizing effect. As an inhibitor of farnesyl transferase, the drug interferes with the addition of the farnesyl group to cellular proteins, which leads to a disruption in the prenylation of the oncogene product Ras. Defarenesis Ras-onkogena leads to apoptosis of tumor cells, inhibits the growth of tumor cells by mitotic division of an interrupt signal to the cells simultaneously reduces the effect of the factors adversely affecting the immune system, resulting in the normalization of the immune status of the organism. Arglabin has a radiosensitizing effect, significantly increasing the frequency of objective tumor regressions and the frequency of pronounced therapeutic pathomorphosis III-IV degree both in the primary tumor and in the metastatically altered lymph nodes.

    Pharmacokinetics:

    With intravenous administration of the drug, the peak peak concentrations of the drug in the blood, which are 31.6 ± 0.6 μg / ml, are established immediately after its administration. Distribution of the drug to tissues and organs within the first two hours after administration, due to the high rate constant. After the second hour of drug administration, the distribution rate slows down by a factor of 25. The drug is able to accumulate in most body tissues, passes into the interstitial fluid and enters the cells of the body. When the drug is distributed in tissues, the transition from blood to tissue proceeds at a rate of 3.75 times greater than the reverse process of tissue release, which confirms the fact of drug deposition in tissues. Metabolic elimination and biodegradation of the drug is due to the destruction of the lactone ring. As a percentage of the total dose administered, up to 27-32% is metabolized in tissues, the remaining amount is excreted unchanged.

    Indications:As a radiosensitizing agent for radiotherapy and chemoradiotherapy for breast, liver, lung and ovarian cancer.
    Contraindications:

    Contraindicated use of the drug during pregnancy and during breastfeeding.

    Hypersensitivity to wormwood.

    Cachexia.

    Pregnancy and lactation:

    Contraindicated use of the drug during pregnancy and during breastfeeding.

    Dosing and Administration:

    For the purpose of radiosensitization against the background of radiation or chemoradiotherapy, Arglabin is administered 15 minutes before the radiation therapy session every other day at a dose of 5 mg / kg, intravenously in jet as a 2% solution, in total 15 injections.

    Before administration, the required calculated dose of Arglabin is diluted in 0.9% sodium chloride solution to a concentration of 20 mg / 1 ml.

    Side effects:

    Perhaps: bitterness in the mouth, dizziness during the administration of the drug, which in the next 5-10 minutes cease on their own.

    Overdose:When using high doses (600-800 mg), there is a burning sensation in the oral cavity, nausea, pruritus, which pass after reducing the dose of the drug.
    Interaction:

    Arglabin potentiates the effect of standard antitumor chemotherapeutic drugs (fluorouracil, cyclophosphamide, methotrexate).

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

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 40 mg.
    Packaging:

    40 mg per bottle of neutral glass with rubber stoppers and aluminum caps.

    For 20 or 60 bottles with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of -5 to 0 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001578
    Date of registration:15.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:KARAGANDINSKAYA PHARMACEUTICAL COMPLEX, TOO KARAGANDINSKAYA PHARMACEUTICAL COMPLEX, TOO Kazakhstan
    Manufacturer: & nbsp
    Information update date: & nbsp11.09.2017
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