Composition, form of production and packaging
The solution for the / m, subconjunctival administration and instillation into the eye is colorless, transparent or slightly opalescent.
1 amp.
interferon alpha-2b human recombinant 500,000 IU
Auxiliary substances: sodium chloride - 7.5 mg, sodium hydrophosphate dodecahydrate - 4.53 mg, sodium dihydrogen phosphate dihydrate - 1.5 mg, disodium edetate 0.1 mg, tween 80 mg 0.1 mg, oxyglutathione 0.03 mg, nipagine 1 mg, water d / and - up to 1 ml.
500000 IU - ampoules (5) - packings of cellular contour (1) - packs cardboard.
500000 IU - ampoules (5) - packings of cellular contour (2) - packs cardboard.
500000 IU - bottles (5) - packings of cellular contour (1) - packs cardboard.
The solution for the / m, subconjunctival administration and instillation into the eye is colorless, transparent or slightly opalescent.
1 amp.
interferon alfa-2b human recombinant 1 000 000 IU
Auxiliary substances: sodium chloride - 7.5 mg, sodium hydrophosphate dodecahydrate - 4.53 mg, sodium dihydrogen phosphate dihydrate - 1.5 mg, disodium edetate 0.1 mg, tween 80 mg 0.1 mg, oxyglutathione 0.03 mg, nipagine 1 mg, water d / and - up to 1 ml.
1000000 IU - ampoules (5) - packings of cellular contour (1) - packs cardboard.
1000000 IU - ampoules (5) - packings of cellular contour (2) - packs cardboard.
1000000 IU - bottles (5) - packings, cell planimetric (1) - packs cardboard.
The solution for the / m, subconjunctival administration and instillation into the eye is colorless, transparent or slightly opalescent.
1 amp.
interferon alfa-2b human recombinant 3 000 000 IU
Auxiliary substances: sodium chloride - 7.5 mg, sodium hydrophosphate dodecahydrate - 4.53 mg, sodium dihydrogen phosphate dihydrate - 1.5 mg, disodium edetate 0.1 mg, tween 80 mg 0.1 mg, oxyglutathione 0.03 mg, nipagine 1 mg, water d / and - up to 1 ml.
3000000 ME - ampoules (5) - packings, cellular outline (1) - packs cardboard.
3,000,000 IU - ampoules (5) - packings of cellular contour (2) - packs of cardboard.
3,000,000 IU - bottles (5) - packings of cellular contour (1) - packs of cardboard.
The solution for the / m, subconjunctival administration and instillation into the eye is colorless, transparent or slightly opalescent.
1 amp.
interferon alfa-2b human recombinant 5,000,000 IU
Auxiliary substances: sodium chloride - 7.5 mg, sodium hydrophosphate dodecahydrate - 4.53 mg, sodium dihydrogen phosphate dihydrate - 1.5 mg, disodium edetate 0.1 mg, tween 80 mg 0.1 mg, oxyglutathione 0.03 mg, nipagine 1 mg, water d / and - up to 1 ml.
5000000 IU - ampoules (5) - packings, cell planimetric (1) - packs of cardboard.
5000000 IU - ampoules (5) - packings, cellular planimetric (2) - packs cardboard.
5000000 IU - bottles (5) - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Lifferon В® has antiviral, antitumor, immunomodulating activity.
PHARMACOKINETICS
Leyfferon В® under parenteral administration undergoes disintegration, partially excreted unchanged, mainly through the kidneys. Like all interferons, in individuals with prolonged use of the drug may cause the appearance of antibodies to interferon, which leads to a decrease in the therapeutic effect.
INDICATIONS
In complex therapy in adults with:
- Acute viral hepatitis B - moderately severe forms at the beginning of icteric period before the 5th day of jaundice (in later terms, the drug is less effective, the drug is not effective in developing hepatic coma and the cholestatic course of the disease);
- with acute prolonged hepatitis B and C, chronic active hepatitis B, C and D without signs of cirrhosis and with the appearance of signs of cirrhosis;
- with viral (influenza, adenovirus, enterovirus, herpetic, parotitic), viral-bacterial and mycoplasma meningoencephalitis. The drug is most effective in the first 4 days of the disease;
- with viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;
- with stage IV kidney, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis), Kaposi's sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myeloid leukemia, histiocytosis-X, subleukemic myelosis, essential thrombocytopenia;
- with multiple sclerosis.
In complex therapy in children with:
- acute lymphoblastic leukemia in remission after the end of inductive chemotherapy (at 4-5 months of remission);
- juvenile respiratory papillomatosis of the larynx, starting the next day after removal by papillomas.
DOSING MODE
Layfferon В® is injected in / m, in the outbreak or under the lesion, subconjunctivalally or locally.
Intramuscular injection
In acute hepatitis B, the drug is administered 1 million ME 2 times / day for 5-6 days, then the dose is reduced to 1 million ME / day and injected for another 5 days. If necessary (after the control biochemical blood tests) the treatment course can be continued 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.
In acute prolonged and chronic active hepatitis B, with the exception of delta infection and without signs of liver cirrhosis, the drug is administered 1 million ME 2 times a week for 1-2 months. In the absence of the effect, the treatment should be extended to 3-6 months or after the end of the 1-2 month treatment, 2-3 similar courses should be performed at intervals of 1-6 months.
With acute prolonged and chronically active hepatitis C without signs of liver cirrhosis, the drug is injected 3 megalons ME 3 times a week for 6-8 months. If there is no effect, prolong treatment until 12 months. Repeated course of treatment after 3-6 months.
With chronic active hepatitis D without signs of liver cirrhosis, the drug is administered 500,000 to 1 million ME / day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.
With chronic active hepatitis B and D with signs of cirrhosis of the liver administered 250-5500 thousand ME / day 2 times a week for 1 month. When signs of decompensation appear, similar repeated courses are conducted at intervals of less than 2 months.
With kidney cancer, the drug is used for 3 million ME 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 million ME to 300 million ME or more.
Poi hairy cell leukemia drug is administered daily to 3-6 megavon ​​of ME for 2 months. After the normalization of the hemogram, the daily dose of the drug is reduced to 1-2 million ME. Then support maintenance is prescribed for 3 million ME 2 times a week for 6-7 weeks. The total amount of the preparation is 420-600 million ME and more
In acute lymphoblastic leukemia in children in remission after the end of inductive chemotherapy (at 4-5 months of remission) - 1 million ME once a week for 6 months, then 1 every 2 weeks for 24 months. Simultaneously, supportive chemotherapy is performed.
In chronic myelogenous leukemia, the drug is administered 3 million IU daily or 6 million IU every other day. The treatment period is from 10 weeks to 6 months.
With histo-cytosis-X, the drug is administered 3 million IU daily for 1 month. Repeated courses with 1-2-month intervals for 1-3 years.
With subleukemic myelosis and essential thrombocytopenia for the correction of hyper-thrombocytosis, the drug is administered 1 million IU daily or 1 day for 20 days.
With malignant lymphomas and Kaposi's sarcoma, the drug is administered at 3 ppm ME / day daily for 10 days in combination with cytostatics (prospidin cyclophosphamide) and GCS.
In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate the I / m of the drug to 3 million ME and intraocular - 2 million ME for 10 days.
In viral, viral-bacterial and mycoplasma meningoencephalitis, the drug is administered 1 million ME 2 times a day for 10 days, in combination with antiviral and antibacterial chemotherapy drugs. The dose and treatment regimen are set individually, depending on the severity of the patient's condition.
In patients with erythrodermic stage of fungal mycosis with increasing temperature above 39 В° C and in case of aggravation of the process, the drug should be discontinued. In case of insufficient therapeutic effect, after 10-14 days a second course of treatment is prescribed. After achieving a clinical effect, a maintenance therapy of 3 million IU is prescribed once a week for 6-7 weeks.
In juvenile respiratory papillomatosis of the larynx, the drug is administered at a dose of 100-150 thousand IU / 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 conducted at intervals of 2-6 months.
With multiple sclerosis, the drug is prescribed for 1 million ME with pyramidal syndrome 3 times / day, with cerebellar syndrome 1-2 times / day for 10 days followed by 1 million IU once a week for 5-6 months. The total amount of the drug is 50-60 million ME.
In persons with a high pyrogenic reaction (39 В° C and above) simultaneous use of indomethacin is recommended for administration.
Perifocal administration
With basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the lesion of 1 million ME once / day daily for 10 days. In the case of pronounced local inflammatory reactions, the injection under the lesion is carried out after 1-2 days. At the end of the course, if necessary, conduct a cryodestruction.
Subconjunctival administration
In stromal keratitis and keratoiridocyclitis, subconjunctival injections of the drug are administered 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 performed under local anesthesia with 0.5% solution of dicain. The course of treatment - from 15 to 25 injections.
Local application
For topical application, 4 ml of 0.9% sodium chloride solution for injections are added to the contents of the ampoule of the drug with an activity of 1 million ME. In case of storage of the drug solution, it is necessary, in accordance with the rules of aseptic and antiseptic, to transfer the contents of the ampoule into a sterile vial with a stopper and store the solution in a refrigerator at 4-10 В° C for no more than 12 hours.
With conjunctivitis and superficial keratitis , two drops of a solution of 6-8 times / day are applied to the conjunctiva of the affected eye . As the inflammatory phenomena disappear, the number of instillations is reduced to 3-4 / day. The course of treatment is 2 weeks.
SIDE EFFECT
With parenteral administration of the drug, chills, fever, fatigue, headache, malaise, flu-like syndrome are possible. These side effects are partially suppressed by acetaminophen / paracetamol.
With topical application of the drug on the mucous membrane of the eye, conjunctival infection, hyperemia of the eye mucosa, single follicles, edema of the conjunctiva of the inferior vault are possible.
Also deviations from the norm of laboratory indicators, manifested by leukopenia, lymphopenia, thrombocytopenia, elevation of ALT level, ALF, are possible. For the timely detection of these abnormalities during therapy, general clinical blood tests should be repeated every 2 weeks, and biochemical every 4 weeks. Typically, these changes are usually minor, asymptomatic and reversible.
In case of severe adverse reactions or long-term preservation, at the doctor's discretion, a temporary dose reduction is allowed (with a decrease in the number of platelets to less than 50,000 cells in 1 Ојl, an absolute number of neutrophils less than 750 cells per 1 Ојl) or interruption of treatment with a decrease in the number of platelets to less than 25,000 cells in 1 Ојl of the absolute number of neutrophils less than 500 cells per 1 Ојl).
CONTRAINDICATIONS
- severe forms of allergic diseases;
- Pregnancy.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy.
DRUG INTERACTION
Interferon alfa is able to reduce the activity of P450 cytochromes and, consequently, interfere with the metabolism of cimetidine, phenytoin, curantyl, theophylline, diazepam, propranolol, warfarin, and some cytostatics.
May enhance neurotoxic, myelotoxic or cardiotoxic effects of drugs administered earlier or simultaneously with it.
It should avoid joint use with drugs that depress the central nervous system, immunosuppressive drugs (including corticosteroids).
It is not recommended to drink alcohol during treatment.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
In accordance with the requirements of JV 3.3.2-1248-03.
The drug should be stored in a place protected from light and inaccessible to children at a temperature of 2 В° to 8 В° C.
Transport the preparation at a temperature of 2 В° to 8 В° C. Shelf life - 3 years.
The drug with expired shelf life is not subject to application.
