Reaferon-EC Lipint lyof for the preparation of suspension for internal use 250000ME N 6
Trade name: Reaferon-ES-Lipint®
Generic name: interferon alpha-2b
Dosage form:
Lyophilisate for the preparation of a suspension for oral administration.
Compound:
One bottle contains: active substance – 250 thousand IU, 500 thousand IU or 1 million IU of human recombinant Interferon alpha-2b; excipients: sodium chloride - 8.01 mg, sodium hydrogen phosphate dodecahydrate - 4.52 mg, sodium dihydrogen phosphate dihydrate - 0.56 mg, Lipoid C 100 (phospholipids [mixture with a percentage of phosphatidylcholine of at least 94%]) - 41.18 mg, cholesterol - 4.53 mg, alpha-tocopherol acetate - 0.56 mg, lactose monohydrate - 91.34 mg.
Pharmacotherapeutic group: cytokine.
Immunobiological and pharmacological properties
Has immunomodulatory and antiviral effects.
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, into 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 alpha-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 synthetases and protein kinases), 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.
Indications for use
Complex therapy for patients with acute hepatitis B, chronic hepatitis B in active and inactive replicative forms, as well as chronic hepatitis B complicated by glomerulonephritis.
Treatment of patients with atopic diseases, allergic rhinoconjunctivitis, bronchial asthma during specific immunotherapy.
Prevention and treatment of influenza and ARVI in adults and children.
Complex therapy of urogenital chlamydial infection in adults.
Complex therapy of febrile and meningeal forms of tick-borne encephalitis in adults.
Emergency prevention of tick-borne encephalitis in combination with anti-tick immunoglobulin.
Contraindications
- Hypersensitivity to interferon or any other components of the drug;
- severe forms of allergic diseases;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- pregnancy and breastfeeding.
Carefully:
Liver and/or renal failure, severe myelosuppression, thyroid disease.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding.
Directions for use and doses
It is administered orally.
Immediately before use, add 1-2 ml of distilled or cooled boiled water to the contents of the bottle. Shaking for 1-5 minutes should form a homogeneous suspension.
For acute hepatitis B, the drug is taken 30 minutes before meals according to the following scheme:
- adults and school-age children - 1 million IU 2 times a day for 10 days;
- children of preschool age (from 3 to 7 years) - 500 thousand IU 1 time per day for 10 days or, after control biochemical blood tests, for a longer time - until complete clinical recovery.
For chronic hepatitis B in active and inactive replicative forms, as well as for 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 IU twice a day for 10 days and then for 1 month - every other day, once a day (at night);
- children of preschool age (from 3 to 7 years) - 500 thousand IU twice a day for 10 days and then - 500 thousand IU for 1 month every other day, once a day (at night).
When carrying out specific immunotherapy, the drug is taken in the morning, 30 minutes after meals, according to the following scheme:
— for allergic rhinoconjunctivitis in adults – 500 thousand IU daily for 10 days (course dose 5 million IU);
- for atopic bronchial asthma in adults - 500 thousand IU once a 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 ARVI, the drug is taken 30 minutes before meals:
— for prevention: adults and children over 15 years old — 500 thousand IU once a day, 2 times a week for 1 month during an increase in incidence; children from 3 to 15 years old - 250 thousand IU once a day, 2 times a week for 1 month during an increase in incidence.
— for the treatment of influenza and ARVI: adults and children over 15 years old – 500 thousand IU daily, 2 times a day for 3 days; children from 3 to 15 years old - 250 thousand IU daily, 2 times a day for 3 days.
For complex therapy of urogenital infections in adults, the drug is taken 30 minutes before meals, 500 thousand IU daily, 2 times a day for 10 days.
For complex therapy of tick-borne encephalitis, the drug is taken 30 minutes before meals:
- for febrile form: 500 thousand IU 2 times a day (morning and evening) for 7 days;
— for the meningeal form: 500 thousand IU 2 times a day (morning and evening) for 10 days;
For emergency prevention of tick-borne encephalitis, the drug is taken 30 minutes before meals, 500 thousand IU 2 times a day (morning and evening) for 5 days. Anti-tick immunoglobulin is administered intramuscularly once no later than the 4th day after the tick bite at a dose of 0.1 ml/kg.
Side effect
When using the drug Reaferon-ES-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-ES-Lipint®, side effects characteristic of this group of drugs are possible: chills, fever, asthenic symptoms (apathy, fatigue, lethargy), headaches, myalgia , arthralgia. These side effects are partially relieved by indomethacin/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, and depression are possible.
From the endocrine system: changes in the thyroid gland are possible.
From laboratory parameters: with long-term use, leukopenia, lymphopenia, thrombocytopenia are possible.
Overdose
There were no cases of overdose. Increased dose-dependent side effects are possible. Treatment is symptomatic.
Interaction with other drugs
Interferon alpha-2b is capable of reducing the activity of cytochrome P450 isoenzymes and, therefore, interfering with the metabolism of cimetidine, phenytoin, dipyridamole, 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 glucocorticosteroids) should be avoided.
Drinking alcohol during treatment is not recommended.
special instructions
For 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 during therapy. It is recommended to monitor the concentration of thyroid-stimulating hormone (TSH).
Impact on the ability to drive vehicles and machinery
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 and speed of psychomotor reactions.
Reaferon-ES-Lipint, 5 pcs., 1 million IU, lyophilisate for the preparation of suspension for oral administration
It is administered orally. Immediately before use, add 1-2 ml of distilled or cooled boiled water to the contents of the bottle. Shaking for 1-5 minutes should form a homogeneous suspension. For acute hepatitis B, the drug is taken 30 minutes before meals according to the following scheme: - adults and school-age children - but 1 million IU 2 times a day for 10 days: - preschool children (from 3 to 7 years old) - 500 thousand each .ME 1 time per day for 10 days or. after control biochemical blood tests, for a longer period until complete clinical recovery. For chronic hepatitis B in active and inactive replicative forms, as well as for chronic hepatitis B associated with glomerulonephritis, the drug is taken 30 minutes before meals according to the following regimen: - adults and school-age children - 1 million IU twice a day for 10 days and then during the first month - every other day, once a day (at night): - preschool children (from 3 to 7 years old) - 500 thousand IU twice a day for 10 days and then - 500 thousand ME for the first month every other day, once a day (at night). When carrying out specific immunotherapy, the drug is taken in the morning. 30 minutes after eating, according to the following scheme: - for allergic rhinoconjunctivitis in adults - 500 thousand IU daily for 10 days (course dose 5 million IU);
-I - for atonic bronchial asthma in adults - 500 thousand IU once a 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 OPBI, the drug is taken 30 minutes before meals: - for prevention: adults and children over 15 years old - 500 thousand IU once a day 2 times a week for 1 month during an increase in incidence: children with 3 to 15 years old 250 thousand IU once a day 2 times a week for 1 month during an increase in incidence. - for the treatment of influenza and ARVI: adults and children over 15 years old - 500 thousand IU daily 2 times a day for 3 days: children from 3 to 15 years old - 250 thousand IU daily 2 times a day for 3 days. For complex therapy of urogenital infections in adults, the drug is taken 30 minutes before meals, 500 thousand IU daily, 2 times a day for 10 days. For complex therapy of tick-borne encephalitis, the drug is taken 30 minutes before meals: - for febrile form: 500 thousand IU 2 times a day (morning and evening) for 7 days: - for mediogeal form: 500 thousand IU 2 times a day day (morning and evening) for 10 days; For emergency prevention of tick-borne encephalitis, the drug is taken 30 minutes before meals, 500 thousand IU 2 times a day (morning and evening) for 5 days. Anti-tick immunoglobulin is administered intramuscularly once no later than the 4th day after the tick bite at a dose of 0.1 ml/kg.
Reaferon-ES-Lipint® Lyophilisate, bottle, 5 pcs., 250,000 IU, for suspension preparation
Directions for use and doses
It is administered orally. Immediately before use, add 1-2 ml of distilled or cooled boiled water to the contents of the bottle. Shaking for 1-5 minutes should form a homogeneous suspension. For acute hepatitis B, the drug is taken 30 minutes before meals according to the following scheme:
- adults and school-age children - but 1 million IU 2 times a day for 10 days;
- children of preschool age (from 3 to 7 years) - 500 thousand IU 1 time / day for 10 days or. after control biochemical blood tests, for a longer period until complete clinical recovery.
For chronic hepatitis B in active and inactive replicative forms, as well as for 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 IU 2 times/day for 10 days and then for 1 month - every other day, 1 time/day (at night);
- children of preschool age (from 3 to 7 years) - but 500 thousand IU 2 times / day for 10 days and then - 500 thousand IU 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 meals. according to the following scheme:
- for allergic rhinoconctivitis in adults - 500 thousand IU daily for 10 days (course dose 5 million IU);
- for atonic bronchial asthma in 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 ARVI, the drug is taken 30 minutes before meals:
- for prevention: adults and children over 15 years old - 500 thousand IU 1 time / day 2 times a week for 1 month during an increase in incidence; children from 3 to 15 years old, 250 thousand IU 1 time / day, 2 times a week for 1 month during an increase in incidence;
- for the treatment of influenza and ARVI: adults and children over 15 years old - 500 thousand IU daily 2 times a day for 3 days: children from 3 to 15 years old - 250 thousand IU daily 2 times a day for 3 days.
For complex therapy of urogenital infections in adults, the drug is taken 30 minutes before meals, 500 thousand IU daily, 2 times a day for 10 days. For complex therapy of tick-borne encephalitis, the drug is taken 30 minutes before meals:
- for febrile form: 500 thousand IU 2 times a day (morning and evening) for 7 days;
- for the meningeal form: 500 thousand IU 2 times a day (morning and evening) for 10 days.
For emergency prevention of tick-borne encephalitis, the drug is taken 30 minutes before meals, 500 thousand IU 2 times a day (morning and evening) for 5 days. Anti-tick immunoglobulin is administered intramuscularly once no later than the 4th day after the tick bite at a dose of 0.1 ml/kg.
