Roncoleukin ampoules 250000me №3

Composition

1 ml solution for infusion and subcutaneous injection contains:

• Active ingredients
  • Recombinant human interleukin-2 0.25 mg (250,000 IU).

• Excipients

Sodium lauryl sulfate 2.5 mg, mannitol 12 mg, dithiotreitol 0.08 mg, ammonium bicarbonate 0.79 mg, water for injection to 1 ml.

In 1 ampoule 1 ml of solution. In the package 3 ampoules.

Indications and usage

• In the complex therapy:
  • In adults:
    • Normal 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.
  • In children:
    • Normal variable immunodeficiency.
    • Combined immunodeficiency.
    • Acute peritonitis.
    • Acute pancreatitis.
    • Osteomyelitis.
    • Severe pneumonia.
    • Bacterial sepsis of newborns.
    • Sepsis.
    • Pulmonary tuberculosis.
    • Other generalized and severe localized infections.

Interleukin-2 (IL-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 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.

Pregnancy and Breastfeeding

The drug is contraindicated in pregnancy.

Contraindications

• Hypersensitivity to interleukin-2 or any component of the drug in history.
• Allergy to yeast.
• Pregnancy.
• Autoimmune diseases.
• heart failure III st.
• Pulmonary heart disease III Art.
• Metastatic brain damage.
• End-stage renal cell cancer.

Carefully:

• Chronic renal failure.
• Decompensated liver failure.

Adverse reactions

• In some cases

The appearance of a short chill.

An increase in body temperature during the administration of Roncoleukin, which is stopped by conventional therapeutic agents, is not a reason to interrupt the administration of the drug, as well as the course of treatment.

• With subcutaneous administration of the drug

There were local reactions - pain, induration, redness at the injection site.

Treatment with Roncoleukin 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 should not be mixed with other drugs in the same syringe or vial.

Overdosage

• Symptoms: overdose manifestations were observed with a single dose of Roncoleukin higher than 7 mg in the form of fever, cardiac arrhythmia, hypotension, dermatological allergic reactions.
• Treatment: side effects stop after the abolition of the drug, if necessary, symptomatic therapy.

Dosage and administration

• In adults: the drug is administered 1 time per day subcutaneously or intravenously in a dose of 0.5–1 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 Ronnoleukin is 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

Conduct from one to three courses of Roncoleukin. The course includes 2 intravenous infusions at a dose of 0.5 mg.

The criterion for the appointment of the second and third courses of Roncoleukin is continued lymphopenia (absolute and / or relative) during treatment.

• When first identified infiltrative destructive pulmonary tuberculosis

3 intravenous infusion of Roncoleukin at a dose of 0.5 mg with an interval of 48 hours on the background of specific polychemotherapy.

•  
  • For preoperative preparation in patients with progressive fibro-cavernous tuberculosis (FCT) of the lungs against the background of specific polychemotherapy

With unilateral PCT - 3 in / in the introduction of Roncoleukin no 1 mg with an interval of 48 hours.

In case of widespread PCT of the lungs with bilateral focal dissemination - 7 intravenous infusions of Roncoleukin: 3 injections during the first week, 1 mg with an interval of 48 hours, then 1 mg 2 times a week for two weeks.

The recommended course of immunotherapy should be completed 7-10 days before surgery.

Appointment of Roncoleukin with pulmonary tuberculosis is impractical with a body mass deficit of more than 30%.

• In disseminated and locally advanced forms of renal cell carcinoma

A single sc or a / 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, 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 is administered intravenously. Schemes of use correspond to those in adults.

The drug is diluted in isotonic sodium chloride solution 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 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.
• Older than 14 years: 0.5 mg in 400 ml of solution.

For ease of use it is also possible to use: Roncoleukin solution for i / v and subcutaneous administration. 500,000 IU amp. [with a knife. amp.] pack. cardboard. 5 Biotech.

• Influence on ability to drive motor transport and control mechanisms

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.

• Store at a temperature of 2 ° C to 8 ° C, transportation is allowed at a temperature of from 9 ° C to 25 ° C for 10 days.