Reaferon lipint for adults. Reaferon - instructions for use, reviews, analogs and release forms (Lipint capsules, injections in EC injection ampoules, EC Lipint suspension) medications for the treatment of herpes, hepatitis and other viral diseases in adults, children


Reaferon-EC- lyophilisate for the preparation of solution for injection and topical use. Contains human recombinant interferon alpha-2b as an active substance - a protein synthesized by a strain of Escherichia coli, into the genetic apparatus of which two genes for human leukocyte interferon alpha-2 are built in. Identical to human leukocyte interferon alpha-2.
The drug Reaferon-EC has antiviral, antitumor, immunomodulatory activity.
When administered parenterally, Reaferon-EC undergoes degradation and is partially excreted unchanged, mainly through the kidneys. Like all interferons, in some individuals, with prolonged use, the drug can cause the appearance of antibodies to interferon, which can lead to a decrease in the therapeutic effect.

Indications for use

Reaferon-EC used in complex therapy in adults:
- for acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period until the 5th day of jaundice (at a later date, the administration of the drug is less effective; the drug is not effective in developing hepatic coma and cholestatic course of the disease);
- in case of acute protracted hepatitis B and C, chronic active hepatitis B, C and D without signs of cirrhosis and when signs of liver cirrhosis appear;
- for viral (influenza, adenovirus, enterovirus, herpetic, mumps), viral-bacterial and mycoplasma meningoencephalitis. The use of the drug is most effective in the first 4 days of the disease;
- for viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;
- for stage IV kidney cancer, hairy cell leukemia, malignant lymphomas of the skin (mycosis fungoides, primary reticulosis), Kaposi's sarcoma, basal cell and squamous cell skin cancers, keratoacanthoma, chronic myeloid leukemia, hysteocytosis-X, subleukemic myelosis, essential thrombocytopenia;
- with multiple sclerosis.
Reaferon-EC used in complex therapy in children: for acute lymphoblastic leukemia in the period of remission after the end of inductive chemotherapy (at 4-5 months of remission); for respiratory papillomatosis of the larynx, starting the next day after removal of papillomas.

Mode of application

A drug Reaferon-EC applied intramuscularly, into or under the lesion, subconjunctivally or locally.
Immediately before use, the contents of the ampoule are dissolved in water for injection (1 ml for intramuscular administration and into the lesion, 5 ml for subconjunctival and local administration).
The drug solution should be transparent, without foreign inclusions. Dissolution time should be from 2 to 4 minutes.
Intramuscular administration
For acute hepatitis B, the drug is administered at a dose of 1,000,000 IU 2 times a day for 5-6 days, then the dose is reduced to 1,000,000 IU per day and administered for another 5 days. If necessary (after control biochemical blood tests), the course of treatment can be continued at 1,000,000 IU 2 times a week for 2 weeks. The course dose is 15,000,000-21,000,000 ME.
In case of acute protracted and chronic active hepatitis B, with the exception of delta infection and without signs of liver cirrhosis, the drug is administered at a dose of 1,000,000 IU 2 times a week for 1-2 months. If there is no effect, extend the treatment to 3-6 months or after completing 1-2 months of treatment, conduct 2-3 similar courses with an interval of 1-6 months.
For acute, protracted and chronically active hepatitis C without signs of liver cirrhosis, the drug is administered at a dose of 3,000,000 IU 3 times a week for 6-8 months. If there is no effect, treatment is extended to 12 months. Repeated course of treatment after 3-6 months.
For chronic active hepatitis D without signs of liver cirrhosis, the drug is administered at 500,000 - 1,000,000 IU per day, 2 times a week for 1 month. Repeated course of treatment after 1-6 months.
For chronic active hepatitis B and D with signs of liver cirrhosis, the drug is administered at 250,000 - 500,000 IU per day, 2 times a week for 1 month. If signs of decompensation appear, similar repeated courses are carried out at intervals of at least 2 months.
For kidney cancer, the drug is used at a dose of 3,000,000 IU daily for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total amount of the drug is from 120,000,000 IU to 300,000,000 IU or more.
For hairy cell leukemia, the drug is administered daily at 3,000,000 -6,000,000 IU for 2 months. After normalization of the hemogram, the daily dose of the drug is reduced to 1,000,000 - 2,000,000 IU. Then maintenance therapy is prescribed at 3,000,000 IU 2 times a week for 6-7 weeks. The total amount of the drug is 420,000,000 - 600,000,000 IU or more.
For acute lymphoblastic leukemia in children in remission after the end of inductive chemotherapy (4-5 months of remission), the drug is administered at a dose of 1,000,000 IU once a week for 6 months, then once every 2 weeks for 24 months. At the same time, maintenance chemotherapy is carried out.
For chronic myeloid leukemia, the drug is administered at 3,000,000 IU daily or 6,000,000 IU every other day. The duration of treatment is from 10 weeks to 6 months.
For hysteocytosis-X, the drug is administered at a dose of 3,000,000 IU daily for 1 month. Repeated courses at 1-2 month intervals for 1-3 years.
For subleukemic myelosis and essential thrombocytopenia, to correct hyperthrombocytosis, the drug is administered at a dose of 1,000,000 IU daily or every other day for 20 days.
For malignant lymphomas and Kaposi's sarcoma, the drug is administered at a dose of 3,000,000 IU per day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and glucocorticosteroids. In the tumor stage, mycosis fungoides and reticulosarcomatosis, it is advisable to alternate intramuscular administration of the drug at 3,000,000 IU and intralesional administration at 2,000,000 IU for 10 days.
In patients with the erythrodermic stage of mycosis fungoides, when the temperature rises above 39 ° C and in case of exacerbation of the process, the drug should be discontinued. If the therapeutic effect is insufficient, a second course of treatment is prescribed after 10-14 days. After achieving a clinical effect, maintenance therapy is prescribed at 3,000,000 IU once a week for 6-7 weeks.
For juvenile respiratory papillomatosis of the larynx, the drug is administered at 100,000 - 150,000 IU per kg of body weight daily for 45-50 days, then at the same dosage 3 times a week for 1 month. The second and third courses are carried out at intervals of 2-6 months.
For multiple sclerosis, the drug is prescribed at a dose of 1,000,000 IU for pyramidal syndrome 3 times a day, for cerebellar syndrome - 1-2 times a day for 10 days, followed by administration of 1,000,000 IU once a week for 5-6 months . The total amount of the drug is 50,000,000 - 60,000,000 ME.
In persons with a high pyrogenic reaction (39 °C and above) to the administration of the drug, simultaneous use of indomethacin is recommended.
Perifocal administration
For basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the lesion at a dose of 1,000,000 IU once a day every day for 10 days. In case of pronounced local inflammatory reactions, injection under the lesion is carried out after 1-2 days. At the end of the course, if necessary, cryodestruction is performed.
Subconjunctival injection
For stromal keratitis and keratoiridocyclitis, subconjunctival injections of the drug are prescribed in a dose of 60,000 IU in a volume of 0.5 ml daily or every other day, depending on the severity of the process. Injections are carried out under local anesthesia with a 0.5% dicaine solution.

The course of treatment is from 15 to 25 injections.
Local application
For local use, the contents of the drug ampoule are dissolved in 5.0 ml of 0.9% sodium chloride solution for injection. If the drug solution is stored, it is necessary, observing the rules of asepsis and antiseptics, to transfer the contents of the ampoule into a sterile vial and store the solution in the refrigerator at 4-10 ° C for no more than 12 hours.
For conjunctivitis and superficial keratitis, apply 2 drops of solution 6-8 times a day to the conjunctiva of the affected eye. As the inflammatory phenomena disappear, the number of instillations is reduced to 3-4. The course of treatment is 2 weeks.

Side effects

When administered parenterally Reaferon-EC chills, fever, fatigue, skin rashes and itching, as well as leukemia and thrombocytopenia are possible; in the case of the latter, blood tests are necessary 2-3 times a day. week. With perifocal administration, a local inflammatory reaction occurs. These side effects are usually not an obstacle to continuing use of the drug.
When the drug is applied topically to the mucous membrane of the eye, conjunctival infection, hyperemia of the eye mucosa, single follicles, and swelling of the conjunctiva of the lower fornix are possible.
In case of pronounced local and general adverse reactions, the administration of the drug should be discontinued.

Contraindications

:
A drug Reaferon-EC contraindicated: in severe forms of allergic diseases; during pregnancy.

Pregnancy

:
The use of the drug is contraindicated Reaferon-EC during pregnancy.

Interaction with other drugs

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.
For the treatment of infectious, inflammatory and viral diseases, the drug can be used as part of combination therapy with antibacterial drugs, glucocorticoids and antiviral drugs (Ribavirin, Zidovudine, etc.).
Drinking alcohol during treatment is not recommended.

Storage conditions

Transport and store in accordance with the requirements of SP 3.3.2.1248-03 in a place protected from light and out of reach of children at a temperature not exceeding 8 °C.
Keep out of the reach of children.

Release form

In ampoules of 500,000 ME or 1,000,000 ME, or 3,000,000 ME, or 5,000,000 ME; 5 ampoules in cell packaging; 1 or 2 blisters in a cardboard box.

Compound

:
In one ampoule Reaferon-EC contains 500,000 ME, 1,000,000 ME, 3,000,000 ME or 5,000,000 ME of human recombinant interferon alpha-2b.
Excipients: human donor albumin - 4.5 mg, sodium chloride - from 8.09 to 9.07 mg, sodium hydrogen phosphate dodecahydrate - from 2.74 to 3.82 mg, sodium dihydrogen phosphate dihydrate - from 0.37 to 0, 58 mg.

Main settings

Name: REAFERON-ES AMPOULES
ATX code: L03AB04 -

Active substance

Interferon alfa-2b human recombinant (interferon alfa-2b)

Release form, composition and packaging

Lyophilisate for preparation of 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 is allowed to form a tablet-like form, hygroscopic.

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 cell surface, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetases and orotein 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 and an increase in the specific cytotoxic effect of lymphocytes on target cells , changes 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.

Pharmacokinetics

Data on the pharmacokinetics of the drug are not provided.

Indications

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 an anti-tick drug.

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

Contraindications

- hypersensitivity to interferon or any other components of the drug;

- severe allergic diseases;

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

- pregnancy;

- period of breastfeeding.

Carefully

Liver and/or renal failure, severe myelosuppression, thyroid disease.

Dosage

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 performing 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

- 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 3 days.

In 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.

In 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 effects

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 Reafsron-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. Allergic reactions may develop.

From the digestive system: nausea, dry mouth, dyspepsia, loss of appetite.

With the nervous system erased: with prolonged use, irritability, anxiety, insomnia, apathy, and depression are possible.

From the endocrine system: changes in the thyroid gland are possible.

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

Overdose

There were no cases of overdose. Increased dose-dependent side effects are possible.

Treatment is symptomatic.

Drug interactions

Interferon alpha-2b is capable of reducing the activity of cytochrome P450 isoenzymes and, therefore, interfering with the metabolism of cimetidium, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some pitostatics. May enhance the neurotoxic, myelotoxic or cardiotoxic effects of drugs prescribed previously or simultaneously with it. Co-administration with drugs should be avoided. CNS depressants, immunosuppressive drugs (including oral and parenteral forms of GCS).


Reaferon-ES-Lipint- human recombinant interferon alpha-2b has immunomodulatory and antiviral effects.
Interferon alpha-2b human recombinant is the active ingredient in the drug, synthesized by bacterial cells of the strain
EscherichiacoliSG-20050/plFlb, 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 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: a change in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.

Indications for use

A drug Reaferon-ES-Lipint used in complex therapy of 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.

Mode of application

Reaferon-ES-Lipint applied 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, the drug is taken 30 minutes before meals according to the following scheme:
- adults and school-age children - 1 million ME2 times a day for 10 days:
- children of preschool age (from 3 to 7 years old) - 500 thousand MEI once a 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 replenished 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 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 ME daily for 10 days (course dose 5 million ME);
- for atonic bronchial asthma in adults - 500 thousand MF. once a day for 10 days, and then 500 thousand MP 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 ME once a day, 2 times a week for 1 month during an increase in incidence; children from 3 to 15 years old
250 thousand ME 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 ME 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.
For complex therapy of urogenital infections in adults, the drug is taken 30 minutes before meals, 500 thousand ME 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 ME2 times a day (morning and evening) for 7 days;
- for the meningeal form: 500 thousand ME2 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 ME 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 effects

When using the drug Reaferon-ES-Lipint No adverse reactions to the drug were observed in clinical studies. Considering that the active ingredient is recombinant interferon alpha-2b. When using the drug Reaferon-EC-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.

Contraindications

Contraindications to the use of the drug Reaferon-ES-Lipint are: 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 period.
With caution: liver and/or renal failure, severe myelosuppression, thyroid disease.

Pregnancy

:
Drug Reaferon-ES-Lipint Contraindicated for use during pregnancy and breastfeeding.

Interaction with other drugs

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

Overdose

:
Cases of drug overdose Reaferon-ES-Lipint was not observed. 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.

Release form

Reaferon-ES-Lipint - lyophilisate for preparing a suspension for oral administration.
250 thousand ME or 500 thousand ME. or 1 million ME of 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 PBX film: 1 or 2 cell packages

Compound

:
In one bottle Reaferon-ES-Lipint 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.

Additionally

:
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 of thyroid-stimulating hormone (TSH).
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.

Main settings

Name: REAFERON-ES-LIPINT
ATX code: L03AB05 -

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 the complex treatment of 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. The duration of treatment is 10 days; if longer therapy is necessary, control biochemical blood tests are performed. 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 specific immunotherapy is carried out: 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 flu-like phenomena in the form of fever, general malaise, and chills. True, most often these symptoms appear with parenteral use of the drug, however, the likelihood of their development with oral administration cannot be excluded. For the same reason, people with hypersensitivity to interferon drugs should be careful.

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 medications that depress the central nervous system.

Reaferon-ES-Lipint can enhance the cardiotoxic, myelotoxic and neurotoxic effects of various drugs used simultaneously 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.

Reaferon-ES-Lipint (active component - interferon-alpha-2b) is a domestic immunobiological drug with antiviral and immunomodulatory effects. It is a freeze-dried human recombinant interferon alpha-2b, enclosed in liposomes. This is a highly purified sterile protein, “composed” of 165 amino acids and has universal activity. The antiviral effect of Reaferon-EC-lipint is based on its ability to influence the synthesis of DNA, RNA and proteins, the immunomodulatory effect is based on an interferon-induced increase in the activity of macrophages and an increase in the selective effect of cytotoxic T-lymphocytes on target cells. These properties of the drug predetermine the possibility of its use in the treatment of viral diseases, including acute respiratory viral infections. Reaferon-ES-lipint is available in the form of a lyophilisate for the preparation of a suspension for oral administration. The suspension is prepared immediately before use: to do this, the contents of the bottle are dissolved in a few milliliters of distilled or boiled water at room temperature. Vigorous shaking for 2-3 minutes results in a homogeneous, ready-to-use suspension. In the acute form of hepatitis B, Reaferon-EC-lipint is taken half an hour before meals, 1 million IU 2 times a day for 10 days (adults and children over 7 years old), 500 thousand IU 1 time a day for 10 days (children from 3 to 7 years old). Depending on the results of control biochemical blood tests, the duration of the drug course can be increased until complete clinical recovery. For the chronic form of hepatitis B, the drug is taken 1 million IU 2 times a day for 10 days, and then 1 time a day for 1 month (adults and children over 7 years old), 500 thousand IU 2 times a day for 10 days, and then - 1 time per day for 1 month (children from 3 to 7 years). As part of specific immunotherapy, Reaferon-EC-lipint is taken in the morning half an hour after breakfast: for allergic rhinoconjunctivitis - 500 thousand.

ME once a day for 10 days at the rate of 5 million ME per course of treatment; for atopic bronchial asthma - 500 thousand IU 1 time per day for the first 10 days, and then every other day for 20 days. The total duration of the medication course is 30 days. To prevent influenza and ARVI, the drug is taken half an hour before meals, 500 thousand IU twice a week for 30 days during epidemic troubles (adults and children under 15 years of age); 250 thousand ME twice a week for 30 days during epidemic troubles (children from 3 to 15 years). When treating influenza and ARVI, 500 thousand IU 2 times a day for 3 days (adults and children over 15 years old), 250 thousand IU 2 times a day for 3 days (children from 3 to 15 years old). For complex treatment of genitourinary tract infections, adults take 500 thousand ME twice a day for 10 days. When Reaferon-ES-lipint is used in the doses recommended in the instructions, the drug practically does not cause unwanted side effects. However, it must be taken into account that recombinant interferon in some cases (for example, in individuals with individual intolerance) can provoke flu-like symptoms. It is necessary to avoid co-administration of Reaferon-EC-lipint with drugs that suppress the central nervous system, as well as immunosuppressants (including systemic glucocorticosteroids). During treatment you should refrain from drinking alcohol. The drug can inhibit the activity of isoenzymes of the cytochrome P450 system, thus affecting the metabolism of warfarin, diazepam, dipyridamole, propranolol, theophylline, phenytoin, cimetidine and some cytostatics.

In conclusion, it would be appropriate to present the results of a study on the effectiveness of Reaferon-EC-lipint in the treatment of urogenital chlamydia in women, conducted at the Siberian State Medical University. In patients taking the drug, a more than twofold increase in antibody titer was noted, which indicates the high effectiveness of immunomodulatory therapy.

Pharmacology

It has a pmmu-modulating and antiviral effect. Human recombinant interferon alpha-2b, which is the active ingredient in the drug, 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 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 cell surface, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetases and orotein 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: a change 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.

Release form

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 is allowed to form a tablet-like form, hygroscopic.

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, α- tocopherol acetate - 0.56 mg, lactose monohydrate - 91.34 mg.

250000 IU - glass bottles (1) - cardboard packs.
250000 IU - glass bottles (3) - contour cell packaging (1) - cardboard packs.
250000 IU - glass bottles (3) - contour cell packaging (2) - cardboard packs.
250000 IU - glass bottles (5) - contour cell packaging (1) - cardboard packs.
250000 IU - glass bottles (5) - contour cell packaging (2) - cardboard packs.
250000 IU - glass bottles (6) - contour cell packaging (1) - cardboard packs.
250000 IU - glass bottles (6) - contour cell packaging (2) - cardboard packs.

Dosage

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.

Overdose

There were no cases of overdose. Increased dose-dependent side effects are possible.

Treatment is symptomatic.

Interaction

Interferon alpha-2b is capable of reducing the activity of cytochrome P450 isoenzymes and, therefore, interfering with the metabolism of cimetidium, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some pitostatics. May enhance the neurotoxic, myelotoxic or cardiotoxic effects of drugs prescribed previously or simultaneously with it. Co-administration with drugs should be avoided. CNS depressants, immunosuppressive drugs (including oral and parenteral forms of GCS).

Drinking alcohol during treatment is not recommended.

Side effects

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 Reafsron-EC-Lipint ® there may be side effects characteristic of this group of drugs: 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.

Damage to 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, and thrombocytopenia are possible.

Indications

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 immunoglobulin.

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

Contraindications

  • hypersensitivity to interferon or any other components of the drug;
  • severe allergic diseases;
  • lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
  • pregnancy;
  • breastfeeding period.

Carefully

Liver and/or renal failure, severe myelosuppression, thyroid disease.

Features of application

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and breastfeeding.

Use for liver dysfunction

The drug is taken with caution in patients with liver failure.

Use for renal impairment

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

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 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.