Pharmacotherapeutic group: cytokine.
ATC code: L03AB05
Pharmacological and immunobiological properties:
The drug has immunomodulatory and antiviral effect.
Human recombinant interferon alfa-2b which is the active substance of the preparation is synthesized by bacterial cells of Escherichia coli strain SG-20050/pIF16, which have a gene of human interferon alfa-2b built into their genetic apparatus. It is a protein containing 165 amino acids and is identical in its characteristics and properties to human leukocyte interferon alfa-2b.
The antiviral effect of interferon alfa-2b is shown during the period of virus reproduction by active involvement in cell metabolic processes. Interferon, 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 protein kinase), the action of which inhibits the formation of viral protein and viral ribonucleic acid in the cell.
Immunomodulatory action of interferon alfa-2b is manifested by the increase of phagocytic activity of macrophages, strengthening of specific cytotoxic effect of lymphocytes on the target cells, alteration of quantitative and qualitative composition of secreted cytokines, alteration of functional activity of immunocompetent cells, alteration of production and secretion of intracellular proteins.
Indications
Treatment of influenza and other acute respiratory viral diseases in adults as part of complex therapy.
Prevention of influenza and other acute respiratory viral diseases in adults during epidemics and seasonal increases in incidence.
Emergency prevention of tick-borne encephalitis in combination with anti-tick immunoglobulin in adults.
Pharmacological effect
Pharmacotherapeutic group: cytokine.
ATX code: L03AB05
Pharmacological and immunobiological properties:
The drug has an immunomodulatory and antiviral effect.
Human recombinant interferon alpha-2b, which is the active ingredient in the drug, is synthesized by bacterial cells of the Escherichia coli strain SG-20050/pIF16, in the genetic apparatus of which the human interferon alpha-2b gene is integrated. 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 alpha-2b manifests itself during the period of virus reproduction through active inclusion in the metabolic processes of cells. Interferon, 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 protein kinase), the action of which inhibits the formation of 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; changes in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.
Special instructions
If allergic reactions occur, you should consult a doctor.
Active ingredient
Interferon alpha-2b
Composition
one capsule contains:
active substance – human recombinant interferon alpha-2b – 500,000 IU;
excipients: sodium chloride – 8.01 mg, sodium phosphate disubstituted 12-water (sodium hydrogen phosphate dodecahydrate) – 4.52 mg, sodium phosphate disubstituted 2-water (sodium dihydrogen phosphate dihydrate) – 0.56 mg, Lipoid C 100 (phosphatidylcholine) – 41.18 mg, cholesterol – 4.53 mg, alpha-tocopherol acetate (vitamin E) – 0.56 mg, lactose monohydrate – 91.34 mg, colloidal anhydrous silicon dioxide – 7.54 mg (not more than 5%);
capsule composition (body and lid): titanium dioxide (E 171) – 2%, gelatin – up to 100%.
Pregnancy
The drug is contraindicated for use during pregnancy and lactation.
Contraindications
– children under 18 years of age;
– pregnancy;
– lactation period;
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
– hypersensitivity to interferon or any other components of the drug.
With caution: renal and/or liver failure, severe myelosuppression, thyroid disease.
Side Effects
When using the drug Reaferon-LIPINT® in clinical studies, no adverse reactions to the drug were observed. Considering that the active ingredient is recombinant interferon alpha-2b, when using the drug Reaferon-LIPINT®, it is possible to develop a flu-like syndrome characteristic of this group of drugs: chills, fever, asthenic symptoms (apathy, fatigue, lethargy), headaches, myalgia, arthralgia. These side effects are partially relieved by ibuprofen/paracetamol.
Allergic reactions may develop.
From the digestive system: nausea, dry mouth, dyspepsia, loss of appetite.
From the nervous system: with prolonged use, irritability, anxiety, insomnia, apathy, depression are possible.
From the endocrine system: changes in the thyroid gland (hypothyroidism, hyperthyroidism) are possible.
From the laboratory parameters: with long-term use, leukopenia, lymphopenia, thrombocytopenia are possible.
Interaction
Interferon alpha-2b is capable of reducing the activity of P-450 cytochromes and, therefore, influencing the metabolism of cimetidine, phenytoin, chimes, theophylline, diazepam, propranolol, warfarin, and some cytostatics. May enhance the neurotoxic, myelotoxic or cardiotoxic effects of drugs prescribed previously or simultaneously with it. Co-administration with drugs that depress the central nervous system and immunosuppressive drugs (including oral and parenteral forms of corticosteroids) should be avoided. Drinking alcohol during treatment is not recommended.
Overdose
There were no cases of drug overdose. Increased dose-dependent side effects are possible. Treatment is symptomatic.
Storage conditions
Store in a place protected from light, at a temperature not exceeding 8 °C. Keep out of the reach of children.
Transportation conditions: at a temperature not exceeding 8 °C. Transportation is allowed at a temperature not exceeding 25 °C for no more than 30 days. During this period, the drug must be returned for further storage in the refrigerator (storage temperature no higher than 8 ° C), the shelf life of the drug is preserved.
Shelf life
3 years. Cannot be used after the expiration date indicated on the packaging.
Manufacturer
Vector-Medica JSC, Russia
Shelf life | 3 years. Not to be used after the expiration date stated on the package. |
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Conditions of storage | Store in the dark place at the temperature not more than 8 ° C. Keep out of the reach of children. Condition of transportation:at the temperature not more than 8 ° C. It is allowed to be transported at the temperature not more than 25 °С during not more than 30 days. During this period the drug shall be returned for further storage in refrigerator (storage temperature is not higher than 8 °С), expiration date of the drug is preserved. |
Manufacturer | Vector-Medica JSC, Russia |
Medication form | capsules |
Brand | Vector-Medica JSC |
Other forms…
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