Description overdue on 06/09/2014
- Latin name: Reaferon-EU
- ATC code: L03AB04
- Active substance: Interferon alfa-2b, recombinant human (Interferon alfa-2b)
- Manufacturer: Vector-Medica JSC, Russia
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use IFN-EU (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
One ampoule preparation contains 500000 ME, ME 1 000 000, 3 000 000 ME or ME 5,000,000 active substance.
Excipients:
- 4, 5 mg - Human albumin donor ;
- 8, 09 and 9, 07 mg - sodium chloride;
- 2, 74 and 3, 82 mg - hydrogen phosphate dodecahydrate sodium;
- from 0, 37 to 0, 58 mg - sodium dihydrogen phosphate dihydrate.
Product form
IFN-EU - a lyophilized powder for solution for subsequent manufacture of topical and injectable.
One package contains 5 or 10 vials of 1 ml of powder.
Pharmacological action
Antitumor, antiviral, immunomodulatory.
Pharmacodynamics and pharmacokinetics
Lyophilisate consists of protein - interferon alfa-2b recombinant human , Freeze-dried and enclosed in liposomes.
The preparation alters the properties of membranes of cells not infected with the virus, thereby preventing the entry of the virus into the cell. It triggers the synthesis of certain specific enzymes that prevent protein synthesis and viral RNA replication, thereby exhibiting antiviral action.
The antiproliferative activity is due to the direct action of inducing transformation in the cytoskeleton and the cell membrane that regulate the processes of cellular metabolism and differentiation, in turn affecting the proliferation of tumor cells mainly. Also interferon It affects the expression of several oncogenes . like normalizing neoplastic cell transformation thereby inhibiting tumor growth.
Immunomodulatory mechanism of action is due to the activation of the natural killer cells and macrophages Who are actively involved in the immune response to tumor cells.
For parenteral use are subjected to decay.
Mainly excreted in the urine, a quantity unchanged.
Indications
The drug is intended for the integrated treatment of adult patients with such diseases:
- acute viral hepatitis B in severe and moderate forms until the fifth day jaundice (ineffective in the later periods of the period, is not effective in the development of hepatic coma and cholestatic During pathology);
- sharp tightening hepatitis B and C , and chronic active hepatitis B, C and D asymptomatic cirrhosis;
- mycoplasma, viruses (adenovirus, influenza, enterovirus, mumps, herpes) , and viral and bacterial meningoencephalitis (most effective during the first 4 days of illness);
- viral keratitis, conjunctivitis, keratouveitis, keratoconjunctivitis;
- Stage IV kidney cancer, hairy cell leukemia, malignant lymphoma skin ( reticulosis initial, mycosis fungoides ) Kaposi's sarcoma, squamous and basal cell skin cancer, chronic myelogenous leukemia, keratoacanthoma, histiocytosis-X, essential thrombocytopenia, subleukemic myelosis;
- multiple sclerosis.
Comprehensive treatment of pediatric patients:
- acute lymphoblastic leukemia in remission (4-5 month) after induction chemotherapy;
- respiratory papillomatosis of larynx.
Contraindications
- heavy allergic reactions ;
- period pregnancy ;
- individual hypersensitivity to interferon.
Side effects
When administered parenterally, the drug may be:
- fatigue;
- temperature rise;
- chills;
- skin rash and itching;
- thrombocytopenia;
- leukopenia.
With the introduction of perifocal:
- local inflammatory reaction.
These side effects are generally not a cause for discontinuation.
When applied topically to the mucous membrane of eyes are possible:
- redness of the mucous eye;
- swelling of the conjunctiva;
- conjunctival infection;
- isolated follicles.
If adverse reactions pronounced character of drug administration should be discontinued.
Instructions for use IFN-EU (method and dosage)
IFN-EU subkonyunktivalno used, topically, by intralesional or directly in the center itself - intramuscularly.
Directly before the procedure one vial powder medicament dissolved in 1 ml of water for injection for intramuscular administration, or in 5 ml of subconjunctival and topical application. Powder Dissolution time of 2 to 4 minutes, the resulting drug solution should be free of inclusions and completely transparent.
For the treatment of various diseases drug Reaferon, instruction on the application recommends the following doses:
Treatment acute hepatitis B It involves intramuscular injections of IFN-EU twice daily at a dose of 1000000 IU. Treatment was carried out for 5-6 days after which the dose is reduced by half to 1 million IU per day. In the reduced dose therapy continues for over 5 days. After the control of biochemical blood tests and further appropriate therapy can be extended to 14 days at a dose of 1 million IU, with the introduction of two times per 7 days. The total dose rate - 15000000-21000000 IU.
Acute hepatitis B and chronic hepatitis B in the active phase, without undergoing merger delta infection and symptoms cirrhosis require dose, and component 1000000 IU intramuscularly administered 2 times a day for seven days 30-60. A negative effect of the treatment, prolonging therapy to 90-180 days or spend 2-3 courses for 30-60 days with intervals of 30 days to six months.
Treatment of acute protracted and chronic active Hepatitis C asymptomatic cirrhosis It carried intramuscularly at a dose of 3000000 IU administered three times per 7 days treatment - 6-8 months. Possible extension to 12 months of therapy in the absence of a positive effect from the treatment. A second course may be appointed after 3-6 months.
The course of therapy chronic active hepatitis D asymptomatic cirrhosis 30 days and it consists of two intramuscular injections per week at a dose of 500000-1000000 IU. In case of need can be a repeated course of therapy after 1-6 months.
The dose of the drug in active chronic hepatitis B or D symptomatic cirrhosis is 250000-500000 IU per day, administered intramuscularly for 30 days, 2 times a week. If symptoms persist decompensation reappointed similar treatments at intervals of not less than 60 days.
Treatment Kidney Cancer start with a daily dose of 3000000 IU administered intramuscularly for 10 days. Repeated courses of treatment may be carried out while maintaining the previous dose at intervals of 3 weeks. As a rule, carried out from 3 to 9 courses and more with a total dose of the drug from 120 million to 300 million IU IU or more.
The daily dose of intramuscular IFN-EU for the treatment of hairy-cell leukemia range from 3000000 to 6000000 IU, with a course of treatment up to 2 months. Normalization haemograms It makes it possible to reduce the daily dose of the drug to 1000000-2000000 IU. Supportive therapy is conducted for 6-7 weeks in a dose of 3 million IU intramuscularly twice in 7 days. The total dose - 420000000-600000000 IU or more.
Treatment lymphoblastic leukemia pediatric patients, carried out in the remission phase (4-5 month) after induction chemotherapy administered in a dose of 1 million IU intramuscularly. Injections do one every 7 days for 6 months and then move on to the introduction of 1 every 2 weeks. The course of treatment, mostly for 2 years. At the same time recommend carrying out maintenance chemotherapy.
Chronic myelogenous leukemia treated at a dose of 3000000 IU intramuscularly administered every day or double dose the next day. Duration of therapy is 2, 5 to 6 months.
Intramuscular reaferon EU-recommended therapy histiocytosis-X Which is carried out in the daily dose of 3000000 IU for 30 days. Perhaps repeat courses over 1-3 years from 1-2 month break.
To correct hyperthrombocytosis at e ssentsialnoy thrombocytopenia and subleukemic myelosis administered by intramuscular injection reaferon EU-daily dose of 1000000 IU. The course of treatment is 20 days.
With Kaposi's sarcoma and malignant Lymphomas the recommended daily dose intramuscular 3000000 IU. Treatment is carried out for 10 days in combination with cytotoxic drugs ( Cyclophosphamide, Prospidin ) And glucocorticoids.
Treatment retikulosarkomatoze and tumor Phase mycosis fungoides It is carried out by intramuscular injection at a dose of 3000000 IU interleaved intralesional injections at a dose of 2000000 IU. The course of treatment 10 days. Patients with mycosis fungoides eritrodermicheskoy in step, the temperature rise above 39 ° C, as well as exacerbation of the drug administration procedure is a signal to stop the treatment. With mild therapeutic effect of a refresher course after 10-14 days. Upon reaching a positive clinical response to a maintenance course of treatment in a dose of 3000000 IU administered one every 7 days for 6-7 weeks.
The daily dose of a medicament for the treatment of juvenile respiratory papillomatosis of the larynx is 100000-150000 IU per kilogram of body weight. This treatment is carried out for 45-50 days. After switching to a similar dose administration for one month three times a week. Further two courses of treatment carried out with an interval of 2-6 months.
Pyramidal syndrome, multiple sclerosis treatable dose 1000000 IU intramuscularly 3 times a day. Cerebellar syndrome, multiple sclerosis -1000000 IU intramuscularly 1-2 times a day. Therapy in both cases is 10 days, and then transferred to the injection of the same dose one time in 7 days for 5-6 months. The total dose varies from 50000000 to 60000000 IU.
Perifocal drug administration Reaferon EU-recommended therapy squamous cell carcinoma, basal cell carcinoma and keratoacanthomas . The drug is administered once a day immediately below the lesion at a dose of 1000000 IU daily for 10 days. At the expressed inflammatory reactions at the injection site, the injection is carried out after 1-2 days. If necessary, after completion of the course of treatment prescribed cryotherapy.
With keratoiridocyklites and stromal keratitis recommend subconjunctival administration in a daily dose of 60,000 IU solution with a volume of 0, 5 ml, every day or every other day. Injections do under local anesthesia, which is used as 0, 5% solution of tetracaine. A full course of therapy is from 15 to 25 injections.
Topical application solution recommended for surface preparation keratitis and conjunctivitis. The procedure consists in applying two drops of the solution on the affected eye conjunctiva, 6-8 times per day. With the subsiding of inflammatory manifestations of the number of installations is reduced to 3-4 per day. The course of treatment is 14 days.
To prepare the solution used locally dissolve the contents of one ampoule reaferon EU in 5 ml of 0, 9% sodium chloride solution. Preparation of a medicament can be stored more than 12 hours in a refrigerator at 2-8 ° C.
Overdose
If all above the recommended doses of IFN-EU, its overdose is unlikely.
Cooperation
In patients with severe pyrogenic response to IFN-EU (body temperature of 39 ° C or more) is recommended to combine the use of Indomethacin.
Interferon alpha-2b may affect the metabolism Phenytoin, cimetidine, Dipyridamole diazepam, theophylline, warfarin, propranolol and some cytostatics.
Terms of sale
Prescription.
Storage conditions
In the refrigerator at a temperature no higher than 8 ° C.
Shelf life
3 years.
Cautions
In the case of leukopenia and thrombocytopenia blood test should be conducted with a frequency of 2-3 times per week.
When pronounced general and local reactions negative character Reaferon administration of the drug should be discontinued and the EU.
With prolonged use, interferons some individuals may develop antibodies that will lead to a decrease in therapeutic effect.
Analogs
Interferon
Nazoferon
Viferon
Infagel
IFN-EU-Lipint
IFN-Lipint
Altevir
Algeron
Genferon Light
Genferon
Grippferon
Additional analogs IFN-EU present different dosage forms: suppositories, drops, solutions, capsules, ointments, gels.
The best-known analogues are:
- Avonex;
- Betaferon;
- Genferon;
- Diaferon;
- Interlock;
- Roferon-A;
- Viferon etc.
During pregnancy and lactation
Do not be appointed.
Reviews of IFN-EU
If you follow all the rules of storage, transportation and use of the drug, feedback on its effectiveness in various diseases adults and children, 95% of the positive. Adverse reactions most frequently observed non-compliance with the storage temperature.
Price Reaferon EU, where to buy
Price IFN pharmacies Russia, depending on the dosage and the number of ampoules, differs. For example, 3000000 IU vials №5 you can buy for the 1200-1500 rubles.
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