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Dosage form: & nbspemulsion for infusions
Composition:

1 bottle of the drug contains:

active substance: Koixa seed oil for injection - 10.0 g;

Excipients: lecithin soy - 1,5 g, glycerol for injection - 2,5 g, water for injection up to 100 ml.
Description:

White, homogeneous oil-in-water emulsion.

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

    An antitumor preparation obtained by extracting a natural active ingredient from Coix seeds (Coix lacryma-jobi L. Var. Ma-yuen (Roman) Stapf, Fem.Gramineae).

    The antitumor effect of KLT is due to the inhibition of mitosis of tumor cells, the induction of their apoptosis, and the effect on the expression of genes by tumor cells.

    Pharmacokinetics:

    Fatty acids, which are part of the Koix seeds oil, slowly accumulate in the blood plasma, and then are quickly removed. The maximum concentration of fatty acids of Coix seed oil in blood plasma is achieved in 3-4 hours and then starts to decrease. Fatty acids of Coix seeds oil are quickly distributed in tissues and body fluids, do not penetrate the blood-brain barrier.

    The drug is excreted by the kidneys and through the gastrointestinal tract (about 40% 24 hours after injection).

    Half-life of fatty acids,which are part of Koix seeds oil, is: for palmitic acid - 7.5 hours, stearic acid - 4.5 hours, linoleic acid - about 9.5 hours.

    The binding of fatty acids of Coix seeds oil to blood proteins is reversible.

    Indications:

    Locally advanced or metastatic non-small cell lung cancer in combination with chemotherapy (sequentially or simultaneously).

    Contraindications:

    The expressed disturbance of lipid metabolism (shock, acute pancreatitis, pathological hyperlipidemia, lipid nephrosis), pregnancy, the period of breastfeeding, increased individual sensitivity to the drug.

    The drug is not used in persons younger than 18 years.

    Dosing and Administration:

    The usual dose of the drug is 200 ml (20.0 g of Coix seed oil) with a slow intravenous injection (for 2 hours) once a day.

    With consistent or simultaneous use of standard courses of chemotherapy, the duration of one course is 21 days.

    The treatment cycle includes two courses. The break between the course of treatment should be 3-5 days.

    When the drug is combined with chemotherapy, the dose of KLT can be reduced.

    At the beginning of intravenous administration it is recommended to set the injection rate of the drug at the level of 20 drops per minute for the first 10 minutes, after 20 minutes the speed can be gradually increase, bringing up to 40-60 drops per minute after 30 minutes from the beginning of administration

    Side effects:

    When using the drug, allergic reactions to lipids in the form of a small fever, chills and mild nausea, phlebitis, and extravasation - pain, irritation of surrounding tissues can be observed. These symptoms usually disappear 3-5 days after the patient's adaptation to the drug. When allergy symptoms appear, you should choose an individual treatment regimen or stop using the drug.

    The irritation of the injection site can be prevented by preheating the drug in water.

    Overdose:

    In case of an unintended overdose, the intensification of the aforementioned adverse reactions is usually not observed. Sometimes phlebitis can be observed, which can be eliminated by administering 50-100 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose before or after intravenous administration of KLT.

    Interaction:It is used as part of complex therapy,at which antitumor drugs of various classes are used. Pharmaceutically incompatible with other solutions.
    Special instructions:

    The drug should not be used in combination with other drugs.

    Discontinue use of the preparation in the emulsion stratification.

    Avoid extravasation.

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

    The drug does not affect the ability to drive vehicles and work with mechanisms.

    Form release / dosage:

    Emulsion for infusion.

    Packaging:

    For 100 ml in a glass bottle of neutral glass type II for infusion for single use, sealed with a plug of butyl rubber to run in with an aluminum cap.

    Each vial with instructions for use is placed in a cardboard box.

    Storage conditions:

    In a dark place at a temperature of no higher than 25 ° C, do not freeze.

    Keep out of the reach of children.

    Shelf life:1,5 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015334 / 01
    Date of registration:08.12.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Zhejiang Kanglayt Pharmaceutical Co., Ltd.Zhejiang Kanglayt Pharmaceutical Co., Ltd. China
    Manufacturer: & nbsp
    Representation: & nbspKANGLIGHT (ELOS) LLC KANGLIGHT (ELOS) LLC China
    Information update date: & nbsp22.11.2017
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