Composition, form of production and packaging
Lyophilizate for the preparation of a suspension for ingestion in the form of a powder or a porous mass of white or yellowish color; flaking, complete or partial, from the surface of the glass of the vial with the formation of tabloid-like form, is hygroscopic.
interferon alfa-2b human recombinant 250 thousand MEU
- "- 500 thousand MEU
- "- 1 million MEU
[PRING] 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 at least 94%)) - 41.18 mg, cholesterol 4.53 mg, tocopherol acetate - 0.56 mg, lactose monohydrate - 91.34 mg.
Glass bottles (1) - cardboard packs.
Glass bottles (3) - packings, cellular, planimetric (1) - cardboard packs.
Glass bottles (3) - packings, cellular, planimetric (2) - cardboard packs.
Glass bottles (5) - packings, cellular, planimetric (1) - cardboard packs.
Glass bottles (5) - packings, cellular, planimetric (2) - packs, cardboard.
Glass vials (6) - packings, cellular, planimetric (1) - cardboard packs.
Glass vials (6) - packings, cellular, planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Has a polymorphic and antiviral effect. Interferon alfa-2b human recombinant, which is an active ingredient 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 built. It is a protein containing 165 amino acids, and is identical in characteristics and properties to human leukocyte interferon alpha-2b.
The antiviral effect of interferon alfa-2b is manifested during the reproduction of the virus by active incorporation into the metabolic processes of the cells. Interferon alfa-2b, interacting with specific receptors on the surface of cells, 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. Immunomodulating effect of interferon alpha-2b is manifested in the increase of phagocytic activity of macrophages, enhancement of specific cytotoxic action of lymphocytes on target cells , changes in quantitative and qualitative composition of secreted cytokines: changes in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.
Data on the pharmacokinetics of the drug are not available.
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 prophylaxis of tick-borne encephalitis in combination with anti-malignant immunoglobulin.
Prevention and treatment of influenza and ARVI in adults and children.
It is applied orally.
Immediately before use, 1-2 ml of distilled or cooled boiled water is added to the contents of the vial. When shaken for 1-5 minutes, a homogeneous suspension should form.
In acute hepatitis B, the drug is taken 30 minutes before meals as follows:
- adults and children of school age - but 1 million ME 2 times / day for 10 days;
- children of preschool age (from 3 to 7 years) - 500 thousand ME each 1 time / day for 10 days or. after the control biochemical blood tests, 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 as follows:
- adults and children of school age - 1 million ME 2 times / day for 10 days and then for 1 month - every other day, 1 time / day (overnight);
- children of preschool age (from 3 to 7 years) - but 500 thousand ME 2 times / day for 10 days and then - 500 thousand ME for 1 month every other day, 1 time / day (overnight).
When carrying out specific immunotherapy, the drug is taken in the morning, 30 minutes after meals. according to the following scheme:
- with allergic rhinocononictivitis adults - 500 thousand ME per day for 10 days (exchange dose of 5 million ME);
- with atonic bronchial asthma adults - but 500 thousand ME 1 time / day for 10 days, and then 500 thousand IU every other day in for 20 days. The total duration of treatment is 30 days.
In the prevention and treatment of influenza and ARVI, the drug is taken 30 minutes before meals:
- for prophylaxis: adults and children over 15 years old - 500 thousand ME each 1 time / day 2 times a week for 1 month during the incidence of morbidity ; children with 3 to 15 years for 250 thousand ME 1 time / day 2 times a week for 1 month during the rise in morbidity;
- with the treatment of influenza and ARVI: adults and children over 15 years old - 500 thousand ME daily 2 times / day for 3 days: children from 3 to 15 years - 250 thousand ME daily 2 times / day during 3 days.
In the complex treatment of urogenital infections in adults, the drug is taken 30 minutes before meals 500,000 ME each day 2 times / day for 10 days.
In the complex treatment of tick-borne encephalitis, the drug is taken 30 minutes before meals:
- with feverish form: 500,000 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.
In case of emergency prophylaxis of tick-borne encephalitis, the drug is taken for 30 minutes before meals for 500,000 ME 2 times / day (morning and evening) for 5 days. Anti-cell immunoglobulin is administered once a day no later than the 4th day after the tick bite at a dose of 0.1 ml / kg.
When using the drug Reaferon-EU-Lipint В® in clinical trials, adverse reactions to the drug were not observed. Given that the active ingredient is recombinant interferon alpha-2b, the side effects typical for this group of drugs are possible with the use of the drug Reafsron-EU - LipintВ®: chills, fever, asthenic symptoms (apathy, fatigue, lethargy) headaches, myalgias, arthralgia. These side effects are partially stopped by indomethacin / paracetamol. Perhaps the development of allergic reactions.
From the digestive system: nausea, dry mouth, dyspepsia, decreased appetite.
With the nerves of the nervous system: with prolonged use, irritability, anxiety, insomnia, apathy, depression are possible.
Co side of the endocrine system: there may be changes on the part of the thyroid gland.
On the part of laboratory indicators : with prolonged use, there may be leukopenia, lymph circulation, thrombocytopenia.
- Hypersensitivity to interferon or any other components of the drug;
- severe allergic diseases;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- the period of breastfeeding.
Hepatic and / or renal failure, expressed myelosuppression, thyroid disease.
PREGNANCY AND LACTATION
The drug is contraindicated for use during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is taken with caution to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is taken with caution to patients with hepatic insufficiency.
With thyroid diseases, the drug should be administered under the supervision of an endocrinologist. When there are signs of dysfunction of the thyroid gland against the background of therapy, it is recommended to control the concentration of thyroid-stimulating hormone (TSH).
Impact on the ability to drive vehicles and mechanisms
During the period of application of the drug to patients experiencing fatigue, drowsiness or disorientation, it is necessary to refrain from engaging in potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions.
Cases of an overdose were not observed. It is possible to increase dose-dependent side effects.
Treatment is symptomatic.
Interferon alfa-2b is able to reduce the activity of cytochrome P450 isoenzymes and, therefore, interfere with the metabolism of cimetidium, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some of the pythostatics. May enhance neurotoxic, myelotoxic or cardiotoxic effects of drugs administered earlier or simultaneously with it. You should avoid co-administration with drugs. oppressive CNS, immunosuppressive drugs (including oral and parenteral forms of SCS).
Drinking alcohol during treatment is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 8 В° C. Transport at a temperature not exceeding 8 В° C. Shelf life - 2 years.
Not applicable after expiry date.