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INSTRUCTIONS
by application medicinal product for medical use

Registration number:

Tradename:

Reaferon-ES-Lipint ®

Group name:

interferon alpha-2b

Dosage form:

Compound:

One bottle contains: active substance– 250 thousand ME, 500 thousand ME or 1 million ME 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 C100 (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.

Description: Powder or porous mass of white or yellowish color. Peeling, complete or partial, from the surface of the glass of the bottle is allowed to form a tablet-like shape. Hygroscopic.

Pharmacotherapeutic group:

ATX code: L03AB05

Immunobiological and pharmacological properties

Has immunomodulatory and antiviral effects.
Interferon alpha-2b human recombinant, which is in the drug active substance, is synthesized by bacterial cells of the Escherichia coli strain SG-20050/pIF16, in whose genetic apparatus the gene is built human interferon alpha-2b. It is a protein containing 165 amino acids and is identical in characteristics and properties to human leukocyte interferon alpha-2b.
Antiviral effect 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; change in functional activity 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 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 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 allergic diseases;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- pregnancy and breastfeeding period.

Carefully

Hepatic and/or renal failure, severe myelosuppression, diseases thyroid gland.

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
- adults and children school age– 1 million ME 2 times a day for 10 days;
- children preschool age(from 3 to 7 years) – 500 thousand ME once a day for 10 days or, after control biochemical blood tests, more long 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 ME 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 ME twice a day for 10 days and then - 500 thousand ME for 1 month every other day, once a day (at night).
When performing 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 adults - 500 thousand ME once a day for 10 days, and then 500 thousand ME 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 ME daily, 2 times a day for 3 days.
At complex therapy 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;
- at meningeal form: 500 thousand ME 2 times a day (morning and evening) for 10 days;
At emergency prevention 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 adverse reactions the drug was not 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. Possible development allergic reactions.
From the outside digestive system: nausea, dry mouth, dyspepsia, loss of appetite.
From the outside nervous system: with prolonged use, irritability, anxiety, insomnia, apathy, and depression are possible.
From the outside endocrine system: changes in the thyroid gland are possible.
From the outside laboratory parameters: with long-term use, leukopenia, lymphopenia, and thrombocytopenia are possible.

Overdose

There were no cases of overdose. Possible dose-dependent enhancement side effects. 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. If signs of thyroid dysfunction appear during therapy, it is recommended to monitor the concentration thyroid-stimulating hormone(TSG).

Impact on the ability to drive vehicles and machinery

During the period of use of the drug, patients experiencing fatigue, drowsiness or confusion should refrain from potentially active activities. dangerous species activities requiring increased concentration attention and speed of psychomotor reactions.

Release form

Lyophilisate for the preparation of a suspension for oral administration.
250 thousand ME or 500 thousand ME, or 1 million ME of the active substance in glass bottles. The bottles are hermetically sealed with rubber stoppers and crimped with aluminum caps.
1 bottle along with instructions for use in a cardboard box.
3, 5 or 6 bottles in a cell package made of PVC film; 1 or 2 blisters along with instructions for use in a cardboard box.

Storage conditions

Store in a place protected from light at a temperature not exceeding 8 °C.
Keep out of the reach of children.

Best before date

2 years.
Cannot be used after expiration date.

Vacation conditions

On prescription.

Manufacturer:

CJSC "Vector-Medica"
630099, Russia, Novosibirsk, st. M. Gorky, 17a;
production address: 630559, Novosibirsk region, Novosibirsk district, r.p. Koltsovo, bldg. 13, 15, 38.

Consumer complaints should be sent to:
630559, Novosibirsk region, Koltsovo village, Vector-Medica CJSC, PO Box 100.

Reaferon-ES-Lipint is an immunomodulatory drug with antiviral activity.

Release form and composition

The drug is produced in the form of a lyophilisate, from which a suspension is prepared for oral administration.

One bottle of Reaferon-ES-Lipinta contains:

  • 250,000 IU, 500,000 IU or 1 million IU of human recombinant interferon alpha-2b;
  • Excipients, such as lecithin (or lipoid C100), sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, sodium chloride, tocopherol, cholesterol, lactose.

The lyophilisate is sold in glass bottles of 1, 3 or 5 pieces. packaged.

Indications for use

As indicated in the instructions, Reaferon-ES-Lipint is prescribed as part of complex treatment the following diseases:

  • Acute hepatitis B;
  • Chronic hepatitis B in replicative form (active and inactive), as well as complicated by glomerulonephritis;
  • Atopic diseases, bronchial asthma, allergic rhinoconjunctivitis (against the background of specific immunotherapy);
  • Urogenital chlamydial infection in adults.

For both adults and children, Reaferon-ES-Lipint, according to the instructions, can be used for the treatment and prevention of acute respiratory infections and influenza.

Contraindications

According to the annotation for the drug, the use of Reaferon-ES-Lipint is contraindicated:

  • If you have hypersensitivity to any component included in its composition;
  • People with severe allergic diseases;
  • Pregnant women.

The medication should be used with caution in patients with cardiovascular diseases - they require hemodynamic control during therapy.

Directions for use and dosage

The suspension prepared from the lyophilisate should be taken orally. To do this, immediately before use, add 1-2 ml of chilled boiled or distilled water to the bottle with powder, shake it well until a homogeneous liquid is formed.

Application regimens for Reaferon-ES-Lipint:

  • For acute hepatitis B: dosage for adults and children over 7 years old - 1 million IU twice a day, children 3-7 years old - 500,000 IU once a day. Duration of treatment – ​​10 days, if necessary, more long-term therapy carry out control biochemical blood tests. The suspension should be taken half an hour before meals;
  • For chronic hepatitis B: dosage for adults and children over 7 years of age – 1 million IU twice a day for 10 days, then at the same dose every other day (optimally before bedtime) for another month, for children 3 -7 years – 500,000 IU twice a day for 10 days, then – 500 thousand IU every other day (preferably at night) for one month. Take Reaferon-ES-Lipint suspension half an hour before meals;
  • For diseases for which it is carried out specific immunotherapy: for atopic bronchial asthma in adults – 500,000 IU once a day for 10 days, then at the same dose every other day for another 20 days; for allergic rhinoconjunctivitis in adults - 500,000 IU once a day, treatment duration - 10 days. Take the suspension 30 minutes after the morning meal;
  • For urogenital infections in adults: 500,000 IU twice a day. Course of therapy – 10 days;
  • For the treatment of influenza and acute respiratory infections: dosage for adults and adolescents over 15 years old - 500,000 IU, for children 3-15 years old - 250,000 IU. The duration of use of Reaferon-ES-Lipint is 3 days. You need to take the drug 30 minutes before meals twice a day;
  • For the prevention of influenza and acute respiratory infections: dosage for adults and adolescents over 15 years of age – 500,000 IU, for children 3-15 years of age – 250,000 IU. It is recommended to take the suspension twice a week for one month during the period of increased incidence.

Side effects

Numerous reviews from patients who have used Reaferon-ES-Lipint indicate that in most cases this immunomodulatory drug is well tolerated and does not have side effects when taken in recommended dosages. However, it is worth considering that recombinant interferon, the active ingredient of the drug, can cause influenza-like phenomena in the form of increased body temperature, general malaise, chills. True, most often these symptoms appear with parenteral use of the drug, however, the likelihood of their development also occurs with orally is not excluded. For the same reason, people with hypersensitivity to interferon drugs.

There are no data on cases of overdose with Reaferon-EC-Lipint.

special instructions

During therapy with interferon drugs, it is prohibited to drink alcohol-containing drinks.

Reaferon-ES-Lipint should not be used simultaneously with immunosuppressive medications (including systemic glucocorticosteroids), as well as with medicines, depressing the central nervous system.

Reaferon-ES-Lipint can enhance cardiotoxic, myelotoxic and neurotoxic effect different drugs, used simultaneously with it or previously prescribed.

Analogs

The following drugs are analogues of Reaferon-ES-Lipint:

  • For active ingredients: Viferon, Grippferon, Interal-P, Recombinant human Interferon, Recombinant Interferon alpha-2, Infagel, Reaferon;
  • By mechanism of action: Avonex, Altevir, Alfaron lyophilisate, Alfaferon, Betaferon, Genfaxon, Genferon, Giaferon, Diaferon, Ingaron, Interlock, Interferal, Human leukocyte Interferon, Intron A, Inferon, Infibeta, Laifferon, Leukinferon, Lokferon, Pegasis, PegIntron, Rebif, Ronbetal, Sveferon, Eberon Alpha R.

Terms and conditions of storage

Reaferon-ES-Lipint is available from pharmacies with a prescription. It can be stored for one year at a temperature not exceeding 8 ºС. If it is necessary to transport the drug, you should also maintain the temperature regime recommended by the manufacturer.

Instructions for use

Reaferon-lipint 500000me n10 caps instructions for use

Dosage form

hard gelatin capsules white. The contents of the capsules are white or white crystalline powder with a yellowish tint. Hygroscopic. Slight clumping is acceptable.

Compound

one capsule contains:

Active substance- interferon alpha-2b human recombinant - 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%.

Pharmacodynamics

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/pIF 16, 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, 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.

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, the development of a flu-like syndrome characteristic of this group of drugs is possible: 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, and depression are possible.

From the endocrine system: changes in the thyroid gland (hypothyroidism, hyperthyroidism) are possible.

From laboratory parameters: with long-term use, leukopenia, lymphopenia, thrombocytopenia are possible.

Selling Features

Available without a prescription

Special storage conditions

Transportation conditions

At a temperature not higher than 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), while the shelf life of the drug is preserved.

Special conditions

If allergic reactions occur, you should consult a doctor.

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.

Indications

Treatment of influenza and other acute respiratory infections 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.

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.

Carefully

Renal and/or liver failure, severe myelosuppression, thyroid disease.

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation.

Drug interactions

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.

Mode of application

Dosage

The drug is taken orally, 30 minutes before meals.

When treating influenza and ARVI - 500,000 IU (1 capsule) daily 2 times a day for 5 days.

For the prevention of influenza and ARVI - 500,000 IU (1 capsule) per day, 2 times a week for a month.

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.

If swallowing is difficult, carefully open the capsules and take the contents with a small amount of water.

Overdose

There were no cases of drug overdose. Increased dose-dependent side effects are possible. Treatment is symptomatic.

Reaferon-EC is a drug that has antiviral, antitumor and immunomodulatory effects.

Release form and composition

Dosage form – lyophilisate for the preparation of solution for injection and local application: hygroscopic powder or porous mass of white color, when diluted, forms a colorless transparent or slightly opalescent solution (in glass ampoules, 5 ampoules in blister packs, 1 or 2 packs in a cardboard pack; in glass bottles, 5 bottles in blister packs, 1 pack in a cardboard box).

Active substance: human recombinant interferon alpha-2b, in 1 ampoule/vial – 0.5 million, 1 million, 3 million or 5 million international units (IU)

Excipients: sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, albumin, solution for infusion 10%.

Indications for use

Complex therapy for adults:

  • Moderate and severe forms of acute viral hepatitis B - at the beginning of the icteric period until the 5th day of jaundice (in more late dates the drug is less effective, not at all effective in the cholestatic course of the disease and developing hepatic coma);
  • Acute protracted and chronic active hepatitis B and C;
  • Chronic hepatitis B, including without and with the delta agent, without and with signs of liver cirrhosis;
  • Viral conjunctivitis, keratoconjunctivitis, keratouveitis, keratoiridocyclitis, keratitis;
  • Stage IV kidney cancer;
  • Malignant lymphomas of the skin (primary reticulosis, mycosis fungoides, reticulosarcomatosis);
  • Kaposi's sarcoma;
  • Subleukemic myelosis;
  • Chronic myeloid leukemia;
  • Keratoacanthoma;
  • Basal cell and squamous cell carcinoma skin;
  • Hairy cell leukemia;
  • Langerhans cell histiocytosis;
  • Essential thrombocythemia.

Complex therapy for children from 1 year:

  • Acute lymphoblastic leukemia in remission after the end of induction chemotherapy (at 4-5 months of remission);
  • Respiratory papillomatosis of the larynx (starting from next day after removal of papillomas).

Contraindications

Absolute:

  • Severe forms of allergic diseases;
  • History of autoimmune disease;
  • Serious illnesses of cardio-vascular system (pronounced violations heart rate, recent myocardial infarction, decompensated heart failure);
  • Epilepsy and other disorders of the central nervous system, mental disorders and diseases in children and adolescents;
  • Diseases of the thyroid gland that cannot be controlled by standard therapeutic methods;
  • Severe liver and/or kidney failure, incl. due to metastases;
  • Autoimmune hepatitis, chronic hepatitis with decompensated cirrhosis of the liver;
  • Creatinine clearance below 50 ml/minute (if necessary, use the drug in combination with ribavirin);
  • The need to use immunosuppressants after transplantation;
  • Serious mental disorders (including a history) in children and adolescents;
  • Pregnancy and breastfeeding period;
  • Hypersensitivity to any component of Reaferon-EC.

The drug is not used in men whose partners are pregnant.

Carefully:

  • Severe myelosuppression;
  • Renal and/or liver failure;
  • Sarcoidosis;
  • Psoriasis;
  • Mental disorders, especially those accompanied by depression, suicidal thoughts and a history of suicide attempts;
  • Heavy chronic diseases (diabetes with a tendency to ketoacidosis, chronic obstructive pulmonary diseases, bleeding disorders).

Directions for use and dosage

Reaferon-EC is used topically, subconjunctivally, into or under the lesion, subcutaneously and intramuscularly.

Immediately before use, the contents of the ampoule/vial are dissolved in water for injection or 0.9% sodium chloride solution (in 1 ml for injection into the lesion, intramuscular and subcutaneous administration, in 5 ml for local and subconjunctival use). The finished solution should be transparent or with slight opalescence, colorless, without sediment or foreign impurities. Dissolution time should be about 3 minutes.

Intramuscular and subcutaneous administration:

  • Malignant lymphomas, Kaposi's sarcoma: 3 million IU for 10 days in combination with cytostatics (cyclophosphamide, prospidium chloride) and glucocorticosteroids. For reticulosarcomatosis, primary reticulosis and the tumor stage of mycosis fungoides, it is advisable to alternate intramuscular injection drug (3 million IU each) and intralesional (2 million IU each) for a course of 10 days;
  • Spicy viral hepatitis B: 1 million IU 2 times a day for 5-6 days, after which the dose is reduced to 1 million 1 time a day for another 5 days. If necessary (based on the results of control biochemical blood tests), treatment is continued at 1 million IU 2 times a week for 2 weeks. The total course dose varies from 15 to 21 million IU;
  • Acute protracted and chronic viral hepatitis B without delta agent and signs of liver cirrhosis: 1 million IU 2 times a week for 1-2 months. If there is no effect, therapy is extended to 3-6 months or 2-3 repeated courses are given at intervals of 1-6 months;
  • Chronic viral hepatitis B with delta agent and without signs of liver cirrhosis: 0.5-1 million IU 2 times a week for 1 month, repeat the course after 1-6 months;
  • Chronic viral hepatitis B with delta agent and signs of liver cirrhosis: 0.25-0.5 million IU 2 times a week for 1 month. If signs of decompensation appear, repeat courses are prescribed at minimum intervals of 2 months;
  • Acute protracted and chronic active hepatitis C without signs of liver cirrhosis: 3 million IU 3 times a week for a 6-8 month course. If there is no effect, therapy is extended to 12 months. If necessary, a repeat course is carried out after 3-6 months;
  • Subleukemic myelosis and essential thrombocythemia for the correction of hyperthrombocytosis: 1 million IU daily or every other day for 20 days;
  • Kidney cancer: 3 million IU 1 time per day for 10 days. Repeated courses (from 3 to 9 or more) are carried out at intervals of 3 weeks. The total course dose can be 120-300 million IU or more;
  • Hairy cell leukemia: 3-6 million IU for 2 months. Further (subject to normalization clinical analysis blood) the dose is reduced to 1-2 million IU per day. Maintenance dose – 3 million IU 2 times a week for 6-7 weeks. The total course dose can range from 420 million to 600 million IU or more;
  • Chronic myeloid leukemia: 3 million ME daily or 6 million ME every other day, for a course of 10 weeks to 6 months;
  • Acute lymphoblastic leukemia in children during the period of remission (4-5 months) after the end of induction chemotherapy: 1 million IU once a week for 6 months, then once every 2 weeks for 24 months. At the same time, maintenance chemotherapy is carried out;
  • Histiocytosis from Langerhans cells: 3 million IU daily for 1 month, if necessary, repeated courses are carried out for 1-3 years at 1-2-month intervals;
  • Respiratory papillomatosis of the larynx: 0.1-0.15 million IU per kilogram of body weight daily for 45-50 days, then at the same dose 3 times a week for 1 month. Then courses 2 and 3 are carried out at intervals of 2-6 months. For patients with a high pyrogenic reaction to the administration of the drug (body temperature 39 ° C or higher), it is recommended to simultaneously prescribe paracetamol or indomethacin.

In patients with the erythrodermic stage of mycosis fungoides, in case of exacerbation of the process or with an increase in body temperature of more than 39 ° C, Reaferon-EC should be discontinued, if insufficient therapeutic effect– after 10-14 days, repeat the course. Maintenance therapy after achieving a clinical effect - 3 million IU once a week for 6-7 weeks.

Perifocal administration (under the site of inflammation) of the drug is indicated for keratoacanthoma, squamous cell and basal cell carcinoma. The recommended dose is 1 million IU once a day for 10 days. Patients who develop pronounced local inflammatory reactions, injections are given after 1-2 days. If necessary, cryodestruction is performed after completion of the course of treatment.

Subconjunctival administration of the drug is indicated for stromal keratitis and keratoiridocyclitis at a dose of 60 thousand IU (0.5 ml volume) daily or every other day. Injections are given under local anesthesia 0.5% dicaine solution. The course of therapy consists of 15-25 injections.

If local use is necessary, Reaferon-EC is dissolved in 5 ml of 0.9% sodium chloride solution. At superficial keratitis and conjunctivitis, the drug is applied to the conjunctiva of the affected eye, 2 drops 6-8 times a day. As it subsides inflammatory process the number of instillations is reduced to 3-4. Duration of therapy is 2 weeks.

If it is necessary to store a diluted solution for topical use, transfer the contents of the ampoule into a sterile vial, observing the rules of antiseptics and asepsis, and store the solution at a temperature of 4-10 ºС (in the refrigerator) for no more than 12 hours.

Side effects

  • From the cardiovascular system: rarely (>1/10000,<1/1000) – аритмия, преходящая обратимая кардиомиопатия; очень редко (<1/10000) – артериальная гипотензия, инфаркт миокарда;
  • From the central nervous system: rarely - anxiety, insomnia, impaired ability to concentrate, nervousness, asthenia, irritability, aggressiveness, depression, suicidal thoughts; very rarely – psychosis, neuropathy;
  • From the gastrointestinal tract: rarely - diarrhea, dyspepsia, abdominal pain, dry mouth, appetite disturbances, nausea, vomiting, weight loss; very rarely - pancreatitis, hepatotoxicity;
  • From the respiratory system: rarely - cough, pharyngitis, pneumonia, dyspnea;
  • From the endocrine system: with long-term use - changes in the thyroid gland; very rarely - diabetes mellitus;
  • From the urinary system: very rarely - renal failure;
  • From the musculoskeletal system: rarely - back pain, leg cramps, myalgia, myositis, rhabdomyolysis;
  • From the skin: rarely - hair loss, increased sweating, skin rashes and itching; when injected into or under the lesion, a local inflammatory reaction occurs;
  • From the immune system: rarely - autoimmune pathology (lupus-like syndrome, rheumatoid arthritis, vasculitis); very rarely - facial swelling, anaphylaxis, angioedema, allergic edema, sarcoidosis;
  • From the organ of hearing: rarely – hearing loss;
  • From the organ of vision: when applied topically on the mucous membrane of the eye - single follicles, hyperemia, swelling of the conjunctiva of the lower fornix; rarely - papilledema, decreased visual acuity, focal changes in the fundus, retinal hemorrhages, optic neuritis, thrombosis of retinal arteries and veins;
  • From laboratory parameters: lymphopenia, leukopenia, thrombocytopenia, anemia, increased activity of alanine aminotransferase, alkaline phosphatase, urea and creatinine concentration;
  • Other: often (>1/100,<1/10) при парентеральном введении – гриппоподобный синдром (повышение температуры, утомляемость, головные боли, озноб, усталость, астения, артралгии, миалгии), частично купирующийся парацетамолом и индометацином.

special instructions

During treatment, it is necessary to periodically conduct blood tests (general - every 2 weeks, biochemical - every 4 weeks) in order to promptly identify deviations in laboratory parameters from the norm.

If the absolute number of neutrophils decreases to less than 0.75-10% and the number of platelets less than 50-10 9 /l, it is recommended to temporarily reduce the dose of interferon by 2 times and repeat the analysis after 1-2 weeks. If changes persist, Reaferon-EC must be discontinued.

If the absolute number of neutrophils decreases to less than 0.5-10% and the number of platelets less than 25-10 9 /l, therapy should be discontinued.

Patients with thyroid diseases must monitor the concentration of thyroid-stimulating hormone before prescribing Reaferon-EC and periodically during treatment (at least once every six months). If the course of the existing disease worsens or dysfunction of the thyroid gland occurs that cannot be adequately corrected with medication, interferon is discontinued.

If an immediate hypersensitivity reaction develops (anaphylaxis, bronchospasm, urticaria, angioedema), the drug is discontinued and appropriate drug therapy is urgently administered. For transient skin rash, there is no need to discontinue interferon.

When using high doses of interferon, disturbances of consciousness, encephalopathy, convulsions and coma are possible. If disorders develop and the reduced dose is ineffective, treatment is discontinued.

Careful monitoring is required for patients who develop signs of liver dysfunction. If symptoms progress, treatment is stopped.

If pneumonia or pneumonitis develops, interferon is discontinued and glucocorticosteroid therapy is prescribed.

If changes occur in the psyche or central nervous system (including depression), the patient should be under the supervision of a psychiatrist for the entire period of treatment and for 6 months after its completion. If the symptoms of the disorder do not regress or worsen, aggressive behavior directed at other people appears, or suicidal thoughts occur, Reaferon-EC should be discontinued and a consultation with a psychiatrist should be scheduled.

Suicidal thoughts and attempts occur more often in children and adolescents, therefore, in the presence of serious mental disorders (including a history), the use of interferon is contraindicated. For adults with such disorders, the drug is prescribed only if appropriate individual screening and treatment for the mental disorder is carried out.

With long-term treatment, visual disturbances are possible, therefore, before starting the use of Reaferon-EC, an ophthalmological examination is necessary. If any complaints of visual disturbances arise during treatment, you should immediately consult an ophthalmologist. If you have diseases that can contribute to changes in the retina (for example, arterial hypertension or diabetes), an ophthalmological examination should be performed at least once every six months. If visual disturbances appear or worsen, the drug is discontinued.

With prolonged treatment, antibodies to interferon may appear in some patients. In most cases, antibody titers are low and they do not affect the effectiveness of therapy.

Patients with progressive cancer and/or diseases of the cardiovascular system should be closely monitored during the treatment period. With the development of arterial hypertension, appropriate therapy and provision of adequate hydration are indicated.

During treatment, drowsiness, fatigue and disorientation may occur. In this case, you should refrain from driving a car and performing potentially dangerous types of work.

Interferon has a stimulating effect on the immune system, so drug immunosuppression may be less effective in patients after a transplant (for example, bone marrow or kidney).

If symptoms of an autoimmune disease appear, it is necessary to conduct a thorough examination of the patient and evaluate the possibility of further treatment with interferon.

Drug interactions

By reducing the activity of cytochrome P-450 isoenzymes, interferon alpha-2b can affect the metabolism of theophylline, warfarin, chimes, diazepam, phenytoin, propranolol, cimetidine, and some cytostatics.

Like all interferons, Reaferon-EC can affect oxidative metabolic processes, which must be taken into account when simultaneously prescribing drugs that are metabolized by oxidation, including theophylline and aminophylline. When concomitantly administering theophylline, it is necessary to monitor its concentration in the blood serum and, if necessary, adjust the dose.

Drinking alcohol is prohibited during treatment.

Interferon alfa-2b can enhance the cardiotoxic, neurotoxic and myelotoxic effects of drugs that are used concomitantly with it or were previously prescribed. The combined use of drugs that depress the central nervous system and immunosuppressive drugs (including parenteral and oral forms of glucocorticosteroids) should be avoided.

With simultaneous use of hydroxyurea, the incidence of cutaneous vasculitis increases.

Terms and conditions of storage

Store in a place protected from light, out of reach of children at temperatures up to 8 °C.

Shelf life – 3 years.

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Reaferon-ES-Lipint: instructions for use and reviews

Reaferon-EC-Lipint is an interferon, an immunomodulatory drug with antiviral action.

Release form and composition

Dosage form: lyophilisate to obtain a suspension for oral administration in the form of a porous mass or powder from white to yellowish-white color, with possible complete or partial detachment from the surface of the bottle with the formation of a tablet-like structure (in glass bottles, 1 bottle in a cardboard box; in blister strip packaging of 3 or 5 bottles, in a cardboard box 1 or 2 packages).

Contents of one bottle:

  • Active substance: human recombinant interferon alpha-2b – 250 thousand International Units (IU), 500 thousand IU or 1 million IU;
  • Additional components: sodium hydrogen phosphate dodecahydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, cholesterol, lactose, lecithin or lipoid C100, tocopherol (vitamin E).

Pharmacodynamics and pharmacokinetics

Interferon is intended for oral administration. Its use orally is especially important in pediatric patients.

The active substance in the drug is human recombinant interferon alpha-2b, which is produced by bacterial cells of the Escherichia coli strain SG-20050/plF 16. The human interferon alpha-2b gene is built into their genetic structure. It is a protein consisting of 165 amino acids, and is completely identical in its parameters and properties to human leukocyte interferon alpha-2b.

The antiviral effect of the active substance of the drug lies in its active inclusion in the metabolic processes occurring in cells during the period of virus reproduction. Interferon alpha-2b interacts with specific receptors on the surface of cell membranes, which leads to intracellular changes. One of the most important processes is the synthesis of specific cytokines and enzymes (protein kinases and 2-5-adenylate synthetase), which prevent the formation of viral ribonucleic acid and viral protein in the cell.

Interferon alpha-2b has an immunomodulatory effect, manifested in changes in the production and secretion of intracellular proteins, changes in the composition (qualitative and quantitative) of released cytokines, an increase in the phagocytic activity of macrophages, and an intensification of the specific cytotoxic effect of lymphocytes on target cells.

When the drug is taken orally, interferon alfa-2b is protected from destruction in the human body by a liposome shell, which ensures the passage of the substance through the digestive tract with virtually no destruction. Penetrating the liver, the substance is absorbed into the blood, where it is slowly released.

When taken orally, the concentration of internal human interferon is 100% higher than when administered by injection. Reaferon-EC-Lipint is optimally suited for the prevention and emergency treatment of influenza and ARVI, reducing the risk of symptoms of the disease by more than 2 times.

The drug contains vitamins C and E, which enhance its antiviral effect 14 times.

Indications for use

Combination therapy for the following diseases:

  • Chronic hepatitis B in active and inactive replicative forms, as well as complicated by glomerulonephritis;
  • Acute hepatitis B;
  • Allergic rhinoconjunctivitis, atopic diseases, bronchial asthma during specific immunotherapy;
  • Urogenital chlamydial infection in adults.

The drug is also indicated for the prevention and treatment of acute respiratory diseases (ARI) and influenza in children and adults.

Contraindications

  • Pregnancy;
  • Severe allergic diseases.

Instructions for use Reaferon-ES-Lipint: method and dosage

The drug is taken orally, immediately before administration, distilled or cooled boiled water in a volume of 1-2 ml is added to the bottle with lyophilisate, and shaken vigorously for 1-5 minutes until a homogeneous suspension is formed.

  • Acute hepatitis B. 1/2 hour before meals, children over 7 years of age and adults are prescribed 1 million IU 2 times a day for 10 days; children 3-7 years old - 500 thousand ME once a day for 10 days or more, until complete recovery, which is determined by the results of control biochemical blood tests;
  • Chronic hepatitis B in active and inactive replicative forms, as well as associated with glomerulonephritis. It is recommended to take 2 times a day 1/2 hour before meals, for 10 days: children over 7 years old and adults - 1 million IU, children 3-7 years old - 500 thousand IU, then for 1 month in the same dose – 1 time per day before bedtime, every other day;
  • Specific immunotherapy for adults. Used 1/2 hour after breakfast: for allergic rhinoconjunctivitis – 500 thousand ME once a day for 10 days (course dose is 5 million ME); for atopic bronchial asthma - 500 thousand IU once a day for 10 days, then at the same dose every other day for 20 days (general course - 30 days);
  • Prevention of influenza and acute respiratory infections. Used during an increase in incidence twice a week for 30 days, 1/2 hour before meals: adults and adolescents over 15 years old - 500 thousand IU, children 3-15 years old - 250 thousand IU;
  • Treatment of influenza and acute respiratory infections. Take 2 times a day for 3 days: adults and adolescents over 15 years old - 500 thousand IU, children 3-5 years old - 250 thousand IU;
  • Complex therapy of urogenital infections. Adults are recommended to take 500 thousand IU twice a day, the course is 10 days.

Side effects

The use of the drug in recommended doses does not cause undesirable effects. However, given that the recombinant interferon contained in it, when administered parenterally, leads to flu-like adverse reactions, caution is required when taking the drug to patients with hypersensitivity to interferon.

There is no information about overdose.

special instructions

It should not be combined with drugs that depress the central nervous system, as well as with immunosuppressive drugs (including glucocorticosteroids for systemic use).

Pregnancy and lactation

The drug should not be used during pregnancy.

Use in children

According to the instructions, Reaferon-ES-Lipint for children is prescribed from the age of 3 years in appropriate doses.

Use for impaired renal and liver function

The drug is taken with caution in case of renal and/or liver failure.

Drug interactions

Interferon alfa-2b may enhance the myelotoxic, neurotoxic or cardiotoxic effects of drugs taken previously or concomitantly.

The drug is able to reduce the activity of cytochrome P450 isoenzymes and, as a result, affect the metabolism of drugs such as dipyridamole, cimetidine, phenytoin, theophylline, propranolol, warfarin, diazepam, as well as some cytostatics.

Analogs

Analogues of Reaferon-ES-Lipint are: Genferon, Interal-P, Interferal, Intron A, Interlock, Inferon, Lokferon, Laifferon, Eberon Alpha R.

Terms and conditions of storage

Store at a temperature not exceeding 8 °C, in a place protected from light, out of reach of children.

Shelf life – 1 year.
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