Roncoleukin® (Roncoleukinum®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInterleukin-2 human recombinantInterleukin-2 human recombinant
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  • Roncoleukin®
    solution d / infusion PC 
    STRATEGY, LLC     Russia
    • Dosage form: & nbspsolution for infusion and subcutaneous administration
    Composition:
    Composition of 1 ml of solution:

    active substances: interleukin-2 human recombinant 0.25 mg, 0.5 mg or 1 mg (= 250,000 IU / 500,000 IU / 1,000,000 IU);

    Excipients: sodium lauryl sulfate - 2.5 mg / 5 mg / 10 mg; Mannitol - 12.5 mg / 25 mg / 50 mg; dithiothreitol - 0.08 mg; ammonium hydrogen carbonate 0.79 mg; water for injection - up to 1 ml.
    Description:The preparation is a clear, colorless or light yellow liquid. When stored at a temperature of 2 to 8 ° C, sodium lauryl sulfate crystals may precipitate, which must dissolve at room temperature for 30 minutes. To accelerate the dissolution, it is possible to tilt the ampoule, avoiding a sharp mixing of the liquid and foaming.

    Characteristics of the preparation

    The active component of the drug - recombinant human interleukin-2 (rIL-2), is a complete structural and functional analogue of endogenous interleukin-2, isolated from cells of the recombinant yeast strain Saccharomyces cerevisiae; is represented by the restored form of the molecule.
    Pharmacotherapeutic group:Cytokine.
    ATX: & nbsp

    L.03.A.C   Interleukins

    Pharmacodynamics:Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helpers I) in response to antigenic stimulation.Synthesized IL-2 affects T-lymphocytes, enhancing their proliferation and subsequent synthesis of IL-2.
    The biological effects of IL-2 are mediated by its binding to specific receptors represented on various cellular targets. IL-2 has a direct effect on the growth, differentiation and activation of T- and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, Langerhans cells. From its presence depends the development of cytolytic activity of natural killers and cytotoxic T-lymphocytes. IL-2 causes the formation of lymphokine-activated killers and activates tumor-infiltrating cells. Expansion of the spectrum of the lysis effect of effector cells causes the elimination of a variety of pathogenic microorganisms, infected and malignant cells, which provides immune protection directed against tumor cells, as well as pathogens of viral, bacterial and fungal infections.
    Indications:
    As part of complex therapy in adults:

    - usual variable immunodeficiency;

    - combined immunodeficiency;

    - acute peritonitis;

    - acute pancreatitis;

    - osteomyelitis;

    - endometritis;

    - severe pneumonia;

    - sepsis;

    - postpartum sepsis;

    - pulmonary tuberculosis;

    - other generalized and severe localized infections;

    - infected thermal and chemical burns;

    - disseminated and locally advanced forms of kidney cancer, in children from 0 years:

    - usual variable immunodeficiency;

    - combined immunodeficiency;

    - acute peritonitis;

    - acute pancreatitis;

    - osteomyelitis;

    - severe pneumonia;

    - bacterial sepsis of newborns;

    - sepsis;

    - other generalized and severe localized infections.
    Contraindications:Hypersensitivity to interleukin-2 or any component of the drug in the anamnesis; allergy to yeast; pregnancy; autoimmune diseases, heart failure III stage, pulmonary heart disease III stage, metastatic brain damage, terminal stage of the kidney cell cancer.
    Carefully:with chronic renal failure, decompensated hepatic insufficiency.
    Dosing and Administration:

    Roncoleukin® is administered 1 time per day subcutaneously or intravenously by 0.5-1.0 mg at intervals 1-3 day, on the course - 1-3 introduction. For intravenous administration, the drug from the ampoule is transferred to 400 ml of isotonic sodium chloride solution for injection.Infusion of the entire volume of the solution is carried out drip during 4-6 hours. The drug solution should be clear, colorless and free of foreign inclusions.

    Immunotherapy Roncoleukin ® is carried out after the completion of urgent and urgent surgical interventions aimed at eliminating the life-threatening consequences of the underlying disease / injury, sanitation and adequate drainage of the infectious focus.

    In the treatment of severe sepsis spend one to three courses Roncoleukin ®. The course includes 2 intravenous infusions in a dose of 0.5 mg every other day. The criterion for prescribing second and third courses of Roncoleukin® is the lymphopenia (absolute and / or relative) that persists during treatment.

    With newly diagnosed infiltrative destructive pulmonary tuberculosis - 3 intravenous infusions Roncoleukin ® in a dose of 0.5 mg with an interval of 48 hours against a background of specific polychemotherapy.

    For preoperative preparation with progressing fibrous-cavernous tuberculosis (FCT) of the lungs against a background of specific polychemotherapy:

    with unilateral FCC - 3 intravenous injections of Roncoleukin ® 1 mg at intervals of 48 hours; with advanced pulmonary tuberculosis with bilateral focal dissemination - 7 IV infusions of Roncoleukin®: 3administration during the first week of 1 mg at intervals of 48 hours, then 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed within 7 to 10 days of surgery. The appointment of Roncoleukin ® for pulmonary tuberculosis is inappropriate with a body weight deficit of more than 30%.

    Course of treatment Roncoleukin® Disseminated and locally advanced forms of renal cell carcinoma includes:

    - a single SC or IV dose of the drug at a dose of 0.5 mg 24 hours before the operation; - as part of an 8-week course of immunochemotherapy, 2.0 mg IV every other day for the first four weeks of treatment. Repeated courses are conducted through 1-2 months.

    Have children Roncoleukin ® is used intravenously drip. Schemes of application correspond to those of adults. The drug is diluted in sodium chloride solution isotonic 0.9% for injection. Single dose of the drug and volume, m isotonic solution in children depends on age:

    -0 to 1 month. -0.1 mg in 30-50 ml of solution;

    - from 1 month. up to 1 year - 0.125 mg in 100 ml of solution;

    - from 1 year to 7 years - 0.25 mg in 200 ml of solution;

    - over 7 years - 0.5 mg in 200 ml of solution;

    - over 14 years - 0.5 mg in 400 ml of solution.

    Side effects:In some cases, during the introduction of Roncoleukin ®, a short-term chill and an increase in body temperature may occur, which is stopped by conventional therapeutic agents and is not a reason for interrupting the administration of the drug, nor for the course of treatment. When subcutaneous administration of the drug, local reactions were noted - tenderness, tightness, redness at the injection site.
    Overdose:Manifestations of overdose were observed with a single dose of Roncoleukin ® above 7 mg in the form of fever, heart rhythm disturbances, hypotension, dermatological allergic reactions. These side effects stop after the withdrawal of the drug, if necessary, symptomatic therapy.
    Interaction:Treatment with Roncoleukin ® can be combined with treatment with all other medicines. When Roncoleukin is used against the background of prolonged therapy with glucocorticosteroid preparations, the activity of the drug may decrease. Roncoleukin® should not be mixed with other medicinal products in one syringe or vial.
    Effect on the ability to drive transp. cf. and fur:Special studies of the effect of the drug on the ability to drive vehicles and use complex equipment were not carried out. In case of adverse reactions from the side of the visual organ and / or a decrease in the ability to concentrate and respond quickly, patients are advised to refrain from driving vehicles or working with complex equipment until such unwanted reactions are resolved.
    Form release / dosage:Solution for infusion and subcutaneous administration, 1 mg / ml, 0.5 mg / ml, 0.25 mg / ml.
    Packaging:Solution for infusion and subcutaneous administration in ampoules of 1 ml in doses of 1 mg of rIL-2 (1,000,000 IU), 0,5 mg of rIL-2 (500,000 IU) or 0.25 mg of rIL-2 (250,000 IU ) for 3 or 5 ampoules in a pack, which is enclosed Instruction for use.
    Storage conditions:The drug is stored at a temperature of 2 ° C to 8 ° C, transportation is allowed at a temperature of 9 ° C to 25 ° C for 10 days. Keep out of the reach of children.
    Shelf life:
    Shelf life - 2 years. Do not use the drug after the expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001810
    Date of registration:27.07.2011 / 22.05.2014
    The owner of the registration certificate:STRATEGY, LLC STRATEGY, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.04.2016
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