Reaferon-es-Lipint lyophilisate for oral administration 250000ME, No. 6

• As part of complex therapy: acute hepatitis B; chronic hepatitis B in active and inactive replicative forms, as well as chronic hepatitis B complicated by glomerulonephritis;

• atopic diseases, allergic rhinoconjunctivitis, bronchial asthma during specific immunotherapy;

• urogenital chlamydial infection in adults;

• febrile and meningeal forms of tick-borne encephalitis in adults.

• Emergency prevention of tick-borne encephalitis in combination with anti-tick-borne immunoglobulin.

• Prevention and treatment of influenza and ARVI in adults and children.

It is administered orally.

Immediately before use, add 1-2 ml of distilled or cooled boiled water to the contents of the bottle. When shaking for 1-5 minutes, a homogeneous suspension should form.

In acute hepatitis B, the drug is taken 30 minutes before meals according to the following scheme: for adults and school-age children - but 1 million ME 2 times / day for 10 days; children of preschool age (from 3 to 7 years old) - 500 thousand ME 1 time / day for 10 days or. after control biochemical blood tests, for a longer time - until complete clinical recovery.

In chronic hepatitis B in active and inactive replicative forms, as well as in chronic hepatitis B. associated with glomerulonephritis, the drug is taken 30 minutes before meals according to the following scheme: adults and school-age children - 1 million ME 2 times / day for 10 days and then within 1 month - every other day, 1 time / day (at night); children of preschool age (from 3 to 7 years old) - but 500 thousand ME 2 times / day for 10 days and then - 500 thousand ME for 1 month every other day, 1 time / day (at night).

When carrying out specific immunotherapy, the drug is taken in the morning, 30 minutes after a meal. according to the following scheme: for adults with allergic rhinoconctivitis - 500 thousand IU daily for 10 days (course dose of 5 million IU); with atonic bronchial asthma for adults - but 500 thousand IU 1 time / day for 10 days, and then 500 thousand IU every other day for 20 days. The total duration of treatment is 30 days.

For the prevention and treatment of influenza and acute respiratory viral infections, the drug is taken 30 minutes before meals: for prevention: adults and children over 15 years old - 500 thousand ME 1 time / day 2 times a week for 1 month during an increase in the incidence; children from 3 to 15 years old, 250 thousand ME 1 time / day, 2 times a week for 1 month during an increase in the incidence; in the treatment of influenza and acute respiratory viral infections: adults and children over 15 years old - 500 thousand ME daily 2 times / day for 3 days: children from 3 to 15 years old - 250 thousand ME daily 2 times / day for 3 days days.

In the complex therapy of urogenital infections in adults, the drug is taken 30 minutes before meals, 500 thousand IU daily, 2 times / day for 10 days.

With the complex therapy of tick-borne encephalitis, the drug is taken 30 minutes before meals: with a febrile form: 500 thousand ME 2 times / day (morning and evening) for 7 days; with meningeal form: 500 thousand ME 2 times / day (morning and evening) for 10 days. For emergency prevention of tick-borne encephalitis, the drug is taken 30 minutes before meals, 500 thousand ME 2 times / day (morning and evening) for 5 days.

Lyophilisate for the preparation of a suspension for oral administration in the form of a powder or porous mass of white or yellowish color; peeling, complete or partial, from the surface of the glass of the bottle with the formation of a tablet-like shape is allowed, hygroscopic.

1 fl.

interferon alpha-2b human recombinant 250 thousand IU

- '- 500 thousand IU

- '- 1 million IU

Excipients: sodium chloride - 8.01 mg, sodium hydrogen phosphate dodecahydrate - 4.52 mg, sodium dihydrogen phosphate dihydrate - 0.56 mg, lipoid C100 (phospholipids (mixture with a percentage of phosphatidylcholine not less than 94%)) - 41.18 mg, cholesterol - 4.53 mg,? - tocopherol acetate - 0.56 mg, lactose monohydrate - 91.34 mg.

• Hypersensitivity to interferon or any other components of the drug;

• severe allergic diseases;

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption; pregnancy;

• period of breastfeeding.

• With caution Hepatic and / or renal failure, severe myelosuppression, thyroid disease.

pharmachologic effect

It has pmmu-modulating and antiviral effects. Interferon alpha-2b human recombinant, which is an active substance in the preparation, is synthesized by bacterial cells of the strain. Escherichia coli SG-20050 / pIF16, in the genetic apparatus of which the human interferon alpha-2b gene is inserted. It is a 165 amino acid protein and is identical in characteristics and properties to human leukocyte interferon alpha-2b. The antiviral effect of interferon alpha-2b is manifested during the reproduction of the virus by actively including cells in metabolic processes. Interferon alpha-2b, interacting with specific receptors on the cell surface, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetase and orotein kinase).the action of which inhibits the formed viral protein and viral ribonucleic acid in the cell. The immunomodulatory effect of interferon alpha-2b is manifested in an increase in the phagocytic activity of macrophages, an increase in the specific cytotoxic effect of lymphocytes on target cells, a change in the quantitative and qualitative composition of secreted cytokines: a change in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.changes in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.changes in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.

Pharmacokinetics

Data on the pharmacokinetics of the drug are not provided.

Side effect

When using the drug Reaferon-EC-LipintЃ in clinical studies, no adverse reactions to the drug were observed. Considering that the active active ingredient is recombinant interferon alpha-2b, when using the drug Reafsron-EC-LipintЃ, side effects typical for this group of drugs are possible: chills, fever, asthenic symptoms (apathy, fatigue, lethargy), headaches, myalgia, arthralgia. These side effects are partially controlled by indomethacin / paracetamol. Development of allergic reactions is possible. From the digestive system: nausea, dry mouth, dyspepsia, loss of appetite. The nervous system is washed off: with prolonged use, irritability, anxiety, insomnia, apathy, depression are possible. From the endocrine system: changes in the thyroid gland are possible.On the part of laboratory parameters: with prolonged use, leukopenia, lymphenia, thrombocytopenia are possible.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

Application for violations of liver function

The drug is taken with caution in patients with hepatic impairment.

Application for impaired renal function

The drug is taken with caution in patients with renal insufficiency.

special instructions

In diseases of the thyroid gland, the use of the drug should be carried out under the supervision of an endocrinologist. When signs of thyroid dysfunction appear on the background of therapy, it is recommended to control the concentration of thyroid-stimulating hormone (TSH). Influence on the ability to drive vehicles and mechanisms During the period of use of the drug, patients experiencing fatigue, drowsiness or disorientation should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Overdose cases were not observed. Possible increased dose-related side effects. Treatment is symptomatic.

Drug interactions

Interferon alfa-2b is able to reduce the activity of cytochrome P450 isoenzymes and, therefore, interfere with the metabolism of cimetidia, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some pittostatics. May enhance the neurotoxic, myelotoxic or cardiotoxic effect of drugs previously prescribed or simultaneously with it. Co-administration with drugs should be avoided. depressing the central nervous system, immunosuppressive drugs (including oral and parenteral forms of GCS). Drinking alcohol during treatment is not recommended.