Roncoleukin ampoules 500000m №3

solution for intravenous and subcutaneous administration

  LS-001810-270711

Roncoleukin^® 
Grouping name:Interleukin-2.
Dosage Form:solution for infusion and subcutaneous.

Composition

1 vial contains interleukin-2 human recombinant 0.1; 0.25; 0.5 or 1 mg (= 100,000 / 250,000 / 500,000 / 1,000,000 IU). Excipients in 1 ml of solution: sodium lauryl sulfate - 1 mg / 2.5 mg / 5 mg / 10 mg, mannitol - 5 mg / 12 mg / 25 mg / 50 mg, dithiothreitol - 0.08 mg, ammonium bicarbonate - 0, 79 mg; water for injection - up to 1 ml.

 
The drug is a clear, colorless or light yellow liquid. When stored at a temperature of 2 to 8^aboutC possible precipitation of sodium lauryl sulfate crystals, which should be dissolved at room temperature within 30 minutes. To speed up the dissolution, you can tilt the ampoule, avoiding rapid mixing of the liquid and foaming.

The active component of the drug - recombinant human interleukin-2 (RIL-2), is a complete structural and functional analog of endogenous interleukin-2, isolated from cells of the recombinant yeast strainSaccharomycescerevisiae; represented by the reduced form of the molecule.

 
Cytokine

L03AC

Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper I) in response to antigen stimulation. The synthesized IL-2 acts on T-lymphocytes, enhancing their proliferation and the subsequent synthesis of IL-2.
The biological effects of IL-2 are mediated by its binding to specific receptors present on various cellular targets.
IL-2 directionally affects the growth, differentiation and activation of T- and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, Langerhans cells. The development of the cytolytic activity of natural killer cells and cytotoxic T-lymphocytes depends on its presence. IL-2 induces the formation of lymphokine-activated killer cells and activates tumor-infiltrating cells.
Expansion of the spectrum of the lytic effect of effector cells causes the elimination of a variety of pathogenic microorganisms, infected and malignant cells, which provides immune protection against tumor cells, as well as pathogens of viral, bacterial and fungal infections.

Indications and usage

As part of complex therapy in adults:

• common 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 renal cell cancer.

children from 0 years:

• common 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 history; yeast allergy; pregnancy; autoimmune diseases, cardiac insufficiency, stage III, pulmonary heart disease, stage III, metastatic brain damage, end-stage renal cell carcinoma.
With caution in chronic renal failure, decompensated liver failure.

Roncoleukin^® administered 1 time per day subcutaneously or intravenously in the dose of 0.5–1.0 mg at intervals of 1–3 days, for a course –– 1-3 injections. For intravenous administration, the drug from the ampoule is transferred to 400 ml of isotonic sodium chloride solution for injection. Infusion of the total volume of the solution is carried out drip for 4-6 hours. The solution of the drug should be clear, colorless and free of impurities.
Immunotherapy with Roncoleukin^® carried out after the completion of urgent and urgent surgical interventions aimed at eliminating the life-threatening consequences of the underlying disease / injury, rehabilitation and adequate drainage of the infectious focus.

When treating severe sepsis spend from one to three courses of Roncoleukin^®. The course includes 2 intravenous infusions at a dose of 0.5 mg every other day. The criteria for the appointment of the second and third courses of Roncoleukin^® is lymphopenia (absolute and / or relative) remaining during treatment.

When first identified infiltrative destructive pulmonary tuberculosis - 3 intravenous infusions of Roncoleukin^® at a dose of 0.5 mg with an interval of 48 hours on the background of specific polychemotherapy.
For preoperative preparation for advanced fibro-cavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy:
with unilateral FCT - 3 in / in the introduction of Roncoleukin^® on 1 mg with an interval of 48 hours;
with widespread PCT of the lungs with bilateral focal dissemination - 7 intravenous infusions of Roncoleukin^®: 3 administrations during the first week, 1 mg with an interval of 48 hours, then 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed 7-10 days before surgery.
Roncoleukin's appointment^® with pulmonary tuberculosis is impractical with a body mass deficit of more than 30%.

Roncoleukin treatment course^® disseminated and locally advanced renal cell carcinomaincludes:

• single dose or in / in the introduction of the drug in a dose of 0.5 mg 24 hours before surgery;
• as part of an 8-week course of immunochemotherapy with 2.0 mg IV, every other day during the first four weeks of treatment. Repeated courses are carried out in 1 - 2 months.

In children Roncoleukin^® used intravenously. Schemes of use correspond to those in adults. The drug is diluted in isotonic sodium chloride solution with 0.9% for injection. A single dose of the drug and the volume of isotonic solution in children depends on age:
from 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;
• older than 7 years - 0.5 mg in 200 ml of solution;
• over 14 years old - 0.5 mg in 400 ml of solution.

 
Overdose manifestations were observed at 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 abolition of the drug, if necessary, symptomatic therapy.

In some cases, during the administration 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 to interrupt the administration of the drug, as well as the course of treatment. With the subcutaneous administration of the drug, local reactions were noted - pain, induration, redness at the injection site.

Drug interactions

Roncoleukin drug treatment^® can be combined with treatment with all other drugs. With the use of Roncoleukin on the background of long-term therapy with glucocorticosteroids, the activity of the drug may decrease. Roncoleukin^® can not be mixed with other drugs in one syringe or vial.

Solution for infusion and subcutaneous administration in 1 ml ampoules in doses of 1 mg RIL-2 (1 000 000 ME), 0.5 mg RIL-2 (500 000 ME), 0.25 mg RIL-2 (250 000 ME ) or 0.1 mg RIL-2 (100 000 ME) in 3 or 5 ampoules in a pack in which the Instructions for Use are inserted and an ampoule knife or scarifier. In the case of using ampoules with a ring of kink or with a notch and a point, the ampoule knife or ampoule scarifier is not inserted.

Special studies of the effect of the drug on the ability to drive and use complex equipment have not been conducted. If undesirable reactions develop on the part of the organ of vision and / or reduce the ability to concentrate and respond quickly, it is recommended that patients refrain from driving or working with complex equipment until these adverse reactions are resolved.

Shelf life - 2 years.
After the expiration date, the drug is not used.

The drug is stored at a temperature of from 2 ° C to 8 ° C.Transportation is allowed at a temperature of from 9 ° C to 25 ° C for 10 days.
Keep out of the reach of children.

Prescription.
Manufacturer Address: Biotech LLC, 199155, St. Petersburg, ul. Ural, 17, building 3, letter E.