Bioleukin

General characteristics. Structure:

Active ingredient: recombinant interleykin-2 person (RIL-2) 250 00 ME or 500 000 ME, or 1 000 000 MO of antiviral activity;
excipients:

                              The substance Quantity for a dosage form which contains RIL-2
                                             250 000 ME                 500 000 ME                     1 000 000 ME
Sodium lauryl sulfate               of 2,5                                                      mg 5,0 mg 10,0 mg
Attracts (Е 421)                            12,5                                                   mg 25,0 mg 50,0 mg
Ditiotreitol                             of 0,08                                                   mg 0,08 mg 0,08 mg
Ammonium hydrocarbonate                of 0,79                                                  mg 0,79 mg 0,79 mg
Water for injections                     to 1 ml                     to 1 ml                             to 1 ml

Pharmacological properties:

Pharmacodynamics. Interleykin-2 it is produced by subpopulation of T lymphocytes (T-helperi І) in response to an antigen challenge. The synthesized SILT-2 influences T lymphocytes, strengthening their proliferation and the following synthesis of SILT-2.
Biological effects of SILT-2 are mediated by its linkng with the specific receptors presented on different cellular targets.
SILT-2 directionally influences growth, differentiation and activation of T - and V-lymphocytes, monocytes, macrophages, oligodendroglialny cells, Langergans's cells. Development of tsitolitichny activity of natural killers and cytotoxic T lymphocytes depends on its presence. SILT-2 causes education of lymphokine-activated killers and activates a tumor - infiltruyushchy cells.
Expansion of a range of the lyseing action of effector cells causes elimination of the various pathogenic microorganisms infected and malignizirovanny cells that provides the host defense directed against tumor cells, and also causative agents of a viral, bacterial and fungal infection.

Pharmaceutical characteristics.

Main physical and chemical properties: transparent, colourless or with a yellowish shade liquid.

Incompatibility.
Bioleukin cannot be mixed with other remedies in one syringe or a bottle.

Indications to use:

1. Septic conditions of a different etiology which are followed имуносупресиею:
surgery: diffuse peritonitis, acute destructive pancreatitis, pankreatogenny sepsis;
traumatology: post-traumatic sepsis, traumatosepsis, osteomyelitis, other septic states;
gynecology: endometritises, other septic states;
Combustiology: burn sepsis;
internal diseases: heavy pneumonia, other septic states;
2. Phthisiology:
- for the first time the revealed infiltrative destructive pulmonary tuberculosis at adults, including, caused by drug resistant strains of mycobacteria of tuberculosis ("And 15,0-A 15,3" for MKB 10), in the presence of an absolute and/or relative l_mfopeniya;
- preoperative preparation at the progressing fibrous and cavernous pulmonary tuberculosis at the adults who are subject to surgical treatment ("And 15,6" for MKB 10).
 3. Oncology:
- treatment of diseminovany and mestnoraspolozhenny forms of pochechnokletochny cancer at adults.

Route of administration and doses:

Bioleukin is entered subcutaneously or intravenously kapelno 1 time a day.
For hypodermic introduction contents of a bottle are parted in 1,5-2 ml of water for injections.
Solution of drug has to be transparent, colourless and not contain foreign inclusions.
For intravenous administration drug from a bottle transfer to 400 ml 0,9% of isotonic solution of sodium of chloride for injections. Then carry out drop infusion for 4-6 hours.

1. At septic conditions of a different etiology at adults: 1-3 introduction subcutaneously or intravenously Bioleykina on 0,5-1 mg (500 000 – 1 000 000 ME) with an interval of 1-3 day as a part of complex therapy.
At treatment of heavy sepsis conduct from 1 to 3 course of Bioleykin. The course includes 2 intravenous infusions in a dose of 0,5 mg (500 00 ME) with an interval of 24 hours. An interval between courses - 48 hours.
At a lymphopenia (absolute and/or relative) which remains throughout treatment, appoint the 2nd and 3rd courses of therapy.
The immunotherapy by Bioleykin is carried out after completion of the urgent and urgent surgeries directed to elimination of effects of the main disease / injury, sanitation and adequate drainage of the infectious center which threaten life.
2. At for the first time the revealed infiltrative destructive pulmonary tuberculosis – 3 intravenous infusions of Bioleykin in a dose of 0,5 mg (500 000 ME) with an interval of 48 hours at specific polychemotherapy.
For preoperative preparation at the progressing fibrous and cavernous tuberculosis (FCT) of lungs at specific polychemotherapy:
- at unilateral FKT - 3 intravenous administrations on 1 mg (1 000 000 ME) with an interval of 48 hours;
- at widespread FKT of lungs from the bilateral focal diseven-nation - 7 intravenous administrations of Bioleykin - 3 introductions for the first week on 1 mg (1 000 00 MO) with an interval of 48 hours, then on 1 mg (1 000 00 MO) 2 times a week for 2 weeks.
The recommended course of an immunotherapy has to be complete in 7-10 days prior to an operative measure.
At a pulmonary tuberculosis with deficit of body weight more than 30% of Bioleykin do not appoint.
3. The course of treatment Bioleykin of disseminovanny and mestnoraspolozhenny forms of pochechnokletochny cancer includes:
- one-time hypodermic or intravenous administration of drug in a dose of 0,5 mg (500 000 ME) in 24 hours prior to operation;
- as a part of a 8 weeks course of an imunokhimioterapiya on 2 mg (2 000 000 ME) intravenously every other day for the first 4 weeks of treatment.
Repeated courses are conducted in 1-2 months.

Features of use:

Bioleykin's use at autoimmune diseases needs careful immunological control. Bystry intravenous administration of drug leads to creation of high concentration of SILT-2 in system blood circulation which can be followed by the phenomena of cardiovascular insufficiency.

Ability to influence speed of response at control of motor transport or work with other mechanisms.
It was not investigated.

Side effects:

In some cases in the course of Bioleykin's introduction emergence of a short-term fever and fervescence which kuprirutsya by usual therapeutic means is possible and is not the basis for interruption of administration of drug, and also a course of treatment.

Interaction with other medicines:

Treatment by drug can be combined with any other remedies, except glucocorticoids.

Contraindications:

Hypersensitivity to interleykinu-2 or to any other component of drug in the anamnesis. An allergy to yeast, autoimmune diseases, heart failure ІІІ degrees, a pulmonary heart ІІ degrees, an acute renal failure ІІ B - ІІІ And, a dekompensirovanny liver failure, existence of arteriovenous emission which is not eliminated with the previous mechanical embolization of a renal artery, an avaskulyarny tumor or a benign tumor of a kidney, a cystous form or an end-stage of pochechnokletochny cancer, metastatic damage of the main brain. Pregnancy period.

Use during pregnancy or feeding by a breast.
Do not apply.

Children.
Experience of use of Bioleykin for children is absent therefore it do not appoint this age category of patients.

Overdose:

It is not revealed.

Storage conditions:

The term of suitability is 2 years. To store in original packaging, in the refrigerator, at a temperature from 2 °C to 8 °C.

Issue conditions:

According to the recipe

Packaging:

On 250 000 MO or on 500 000 MO, or on 1 000 000 MO in bottles No. 5.