Roncoleukin, 0.25 mg/ml 1 ml 3 pcs

Indications

As part of the complex therapy in adults:

• common variable immunodeficiency;
• combined immunodeficiency;
• acute peritonitis;
• acute pancreatitis;
• osteomyelitis;
• endometritis;
• severe pneumonia;
• sepsis;
• tuberculosis of the lungs;
• other generalized and severe localized infections;
• infected thermal and chemical burns;
• disseminated and locally disseminated forms of renal cell cancer.

in children from 0 years of age:

• common variable immunodeficiency;
• combined immunodeficiency;
• acute peritonitis;
• acute pancreatitis;
• osteomyelitis;
• severe pneumonia;
• bacterial sepsis of newborns;
• sepsis;
• other generalized and severe localized infections.

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Composition

Active ingredients:

Human recombinant interleukin-2 0.25 mg, 0.5 mg, or 1 mg (=250,000 IU / 500,000 IU / 1,000,000 IU);

Additives:

sodium lauryl sulfate, 2.5 mg / 5 mg / 10 mg;

mannitol, 12.5 mg / 25 mg / 50 mg;

p> dithiotreitol – 0.08 mg;

ammonium bicarbonate – 0.79 mg;

water for injection – up to 1 ml.

How to take, the dosage

Roncoleukin® is administered once daily by subcutaneous or intravenous drops of 0.5-1.0 mg at 1 to 3 day intervals, for a course of 1-3 injections. For intravenous administration the drug from the ampoule is transferred into 400 ml of isotonic sodium chloride solution for injection. Infusion of the entire solution volume is carried out by drip for 4-6 hours. The drug solution should be clear, colorless and contain no foreign substances.

The immunotherapy with RoncoleukinÒ is carried out after completion of emergency and urgent surgical interventions aimed at elimination of life-threatening consequences of the underlying disease/trauma, sanation and adequate drainage of the infectious focus.

In the treatment of severe sepsis, one to three courses of RoncoleukinÒ are given. The course includes two intravenous infusions at a dose of 0.5 mg every other day. The criterion for prescribing the second and third courses of RoncoleukinÒ is lymphopenia (absolute and/or relative) that persists during treatment.

In case 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 advanced fibrotic cavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy:

In unilateral FCT – 3 IV injections of Roncoleukin® 1 mg at 48-hour intervals;
in advanced pulmonary FCT with bilateral focal dissemination – 7 IV injections of Roncoleukin®: 3 injections during the first week of 1 mg at 48-hour intervals, then 1 mg twice a week for two weeks. The recommended course of immunotherapy should be completed 7 to 10 days before surgery.

The administration of Roncoleukin® in pulmonary tuberculosis is inadvisable if the body weight deficit is more than 30%.

The course of treatment with Roncoleukin® for disseminated and locally advanced forms of renal cell cancer includes:

– a single p/c or IV infusion of the drug at a dose of 0.5 mg 24 hours before surgery;

– as part of an 8-week course of immunochemotherapy at 2.0 mg IV every other day for the first four weeks of treatment. Repeated courses are given 1 to 2 months later.

In children RoncoleukinÒ is used as an intravenous drip. The regimens are the same as in adults. The drug is diluted in 0.9% isotonic sodium chloride solution for injection. The single dose of the drug and the volume of isotonic solution in children depends on their 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 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.

Interaction

Treatment with Roncoleukin® can be combined with treatment with all other medicines.

Special Instructions

If stored at 2 to 8°C, sodium lauryl sulfate crystals may precipitate and should dissolve at room temperature within 30 minutes.

Contraindications

Hypersensitivity to interleukin-2 or any component of the drug in history; allergy to yeast; pregnancy; autoimmune diseases, heart failure III stage, pulmonary heart failure III stage, metastatic brain lesion, terminal stage of renal cell cancer.

With caution in chronic renal failure, decompensated hepatic failure.

Side effects

In some cases during Roncoleukin® therapy short-term chills and fever may occur, which are treated with the usual therapeutic means and are not reasons for discontinuation of therapy.

Overdose

Manifestations of overdose were observed at a single dose of Roncoleukin® higher than 7 mg in the form of fever, cardiac arrhythmias, hypotension, dermatological allergic reactions.