Roncoleukin 500000 IU solution ampoules 3 pcs.

In the context of complex therapy for 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 carcinoma.

For children from 0 years:
• common variable immunodeficiency;
• combined immunodeficiency;
• acute peritonitis;
• acute pancreatitis;
• osteomyelitis;
• severe pneumonia;
• bacterial sepsis in newborns;
• sepsis;
• other generalized and severe localized infections.

Roncoleukin® is administered once daily subcutaneously or intravenously by drip at a dose of 0.5 - 1.0 mg with intervals of 1 - 3 days, for a course of 1-3 administrations. For intravenous administration, the drug from the ampoule is transferred to 400 ml of isotonic sodium chloride solution for injections. The infusion of the entire volume of the solution is carried out by drip over 4-6 hours. The solution must be transparent, colorless, and free of foreign inclusions.
Immunotherapy with Roncoleukin® is conducted after the completion of emergency and urgent surgical interventions aimed at eliminating life-threatening consequences of the underlying disease/injury, sanitation, and adequate drainage of the infection focus.
In the treatment of severe sepsis, one to three courses of Roncoleukin® are conducted. The course includes 2 intravenous infusions at a dose of 0.5 mg every other day. The criterion for prescribing the second and third courses of Roncoleukin® is the persistent lymphopenia (absolute and/or relative) during treatment.
In cases of newly diagnosed infiltrative destructive pulmonary tuberculosis - 3 intravenous infusions of Roncoleukin® at a dose of 0.5 mg with an interval of 48 hours against the background of specific polychemotherapy.
For preoperative preparation in progressive fibrous-cavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy: in unilateral FCT - 3 intravenous administrations of Roncoleukin® at 1 mg with an interval of 48 hours; in disseminated FCT of the lungs with bilateral focal dissemination - 7 intravenous administrations of Roncoleukin®: 3 administrations during the first week at 1 mg with an interval of 48 hours, followed by 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed 7 - 10 days before the surgical intervention.
The use of Roncoleukin® in pulmonary tuberculosis is not advisable in cases of body weight deficiency exceeding 30%.
The treatment course of Roncoleukin® for disseminated and locally advanced forms of renal cell carcinoma includes:

• a single subcutaneous or intravenous administration of the drug at a dose of 0.5 mg 24 hours before surgery;

• as part of an 8-week course of immuno-chemotherapy at 2.0 mg intravenously every other day during the first four weeks of treatment. Repeated courses are conducted after 1 - 2 months.
In children, Roncoleukin® is administered intravenously by drip. The administration schemes correspond to those in adults. The drug is diluted in a 0.9% isotonic sodium chloride solution for injections. The single dose of the drug and the volume of isotonic solution in children depend on age:

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

• from 1 month 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.

Composition per 1 ml of solution:
active substances: recombinant human interleukin-2 0.5 mg (=500,000 IU);
excipients: sodium lauryl sulfate - 5 mg; mannitol - 25 mg; dithiothreitol - 0.08 mg; ammonium bicarbonate - 0.79 mg; water for injections - up to 1 ml.

The preparation is a clear colorless or light yellow liquid. When stored at a temperature between 2°C and 8°C, the precipitation of sodium lauryl sulfate crystals may occur, which should dissolve at room temperature within 30 minutes. To expedite dissolution, the ampoule can be tilted, avoiding vigorous mixing of the liquid and foaming.

Increased sensitivity to interleukin-2 or any component of the drug in history; allergy to yeast; pregnancy; autoimmune diseases; heart failure stage III; pulmonary heart failure stage III; metastatic brain lesions; terminal stage of renal cell carcinoma.
Use with caution in chronic renal failure, decompensated liver failure.

Effect on the ability to drive vehicles
No specific studies have been conducted on the effect of the drug on the ability to drive vehicles and use complex equipment. In the event of adverse reactions from the visual organ and/or decreased ability to concentrate and react quickly, patients are advised to refrain from driving vehicles or operating complex equipment until the aforementioned adverse reactions are resolved.

In some cases, during the administration of Roncoleukin®, transient chills and an increase in body temperature may occur, which can be managed with standard therapeutic measures and do not warrant discontinuation of the drug administration or the treatment course. Local reactions have been noted with subcutaneous administration of the drug - pain, induration, and redness at the injection site.

Symptoms of overdose, measures for assistance in case of overdose
Overdose manifestations have been observed with a single dose of Roncoleukin® exceeding 7 mg, presenting as fever, arrhythmia, hypotension, and dermatological allergic reactions. These side effects are alleviated after discontinuation of the drug; if necessary, symptomatic therapy is administered.

Treatment with Roncoleukin® can be combined with the treatment of all other medications. When using Roncoleukin® during prolonged therapy with glucocorticosteroids, the activity of the drug may be reduced. Roncoleukin® should not be mixed with other medications in the same syringe or vial.

The active component of the drug is recombinant human interleukin-2 (rIL-2), which is a complete structural and functional analog of endogenous interleukin-2, isolated from cells of the recombinant strain of yeast Saccharomyces cerevisiae; it is presented in a restored form of the molecule.
Pharmacotherapeutic group: Cytokine
Pharmacological (immunobiological) properties
Interleukin-2 is produced by a subpopulation of T-lymphocytes (T-helper I) in response to antigenic stimulation. The synthesized IL-2 acts on 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 present on various cellular targets.
IL-2 specifically influences the growth, differentiation, and activation of T- and B-lymphocytes, monocytes, macrophages, oligodendroglial cells, and Langerhans cells. The development of cytolytic activity of natural killer cells and cytotoxic T-lymphocytes depends on its presence. IL-2 induces the formation of lymphokine-activated killers and activates tumor-infiltrating cells.
The expansion of the lytic action spectrum of effector cells leads to the elimination of various pathogenic microorganisms, infected and malignant cells, which provides immune protection against tumor cells, as well as against viral, bacterial, and fungal infections.

Store the medication at a temperature between 2°C and 8°C. Transportation is allowed at a temperature between 9°C and 25°C for up to 10 days.