Composition, form of production and packaging
Lyophilizate for the preparation of solution for intramuscular, subconjunctival administration and instillation into the eye in the form of powder or white porous mass, hygroscopic.
1 amp.
interferon alpha-2b human recombinant 500,000 IU
Auxiliary substances: sodium chloride - 9.2 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 2.74 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.37 mg, dextran with MM. from 30,000 to 40,000 (in view of the "Reonopolyglucin" solution containing 100 mg / 1 ml of dextran in a 0.9% solution of sodium chloride) - 8 mg, sorbitol (D-sorbitol) - 3 mg, urea (carbamide) - 0.1 mg.
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.
Lyophilizate for the preparation of solution for intramuscular, subconjunctival administration and instillation into the eye in the form of powder or white porous mass, hygroscopic.
1 amp.
interferon alfa-2b human recombinant 1 000 000 IU
Auxiliary substances: sodium chloride - 9.2 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 2.74 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.37 mg, dextran with MM. from 30,000 to 40,000 (in view of the "Reonopolyglucin" solution containing 100 mg / 1 ml of dextran in a 0.9% solution of sodium chloride) - 8 mg, sorbitol (D-sorbitol) - 3 mg, urea (carbamide) - 0.1 mg.
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.
Lyophilizate for the preparation of solution for intramuscular, subconjunctival administration and instillation into the eye in the form of powder or white porous mass, hygroscopic.
1 amp.
interferon alfa-2b human recombinant 3 000 000 IU
Auxiliary substances: sodium chloride - 9.2 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 2.74 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.37 mg, dextran with MM. from 30,000 to 40,000 (in view of the "Reonopolyglucin" solution containing 100 mg / 1 ml of dextran in a 0.9% solution of sodium chloride) - 8 mg, sorbitol (D-sorbitol) - 3 mg, urea (carbamide) - 0.1 mg.
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.
Lyophilizate for the preparation of solution for intramuscular, subconjunctival administration and instillation into the eye in the form of powder or white porous mass, hygroscopic.
1 amp.
interferon alfa-2b human recombinant 5,000,000 IU
Auxiliary substances: sodium chloride - 9.2 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 2.74 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.37 mg, dextran with MM. from 30,000 to 40,000 (in view of the "Reonopolyglucin" solution containing 100 mg / 1 ml of dextran in a 0.9% solution of sodium chloride) - 8 mg, sorbitol (D-sorbitol) - 3 mg, urea (carbamide) - 0.1 mg.
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
Liferon В® has antiviral, antitumor, immunomodulating activity.
PHARMACOKINETICS
Leyfferon В® under parenteral administration undergoes disintegration, partially excreted in an altered form, 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
Adults in the complex therapy:
- Acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period before the 5th day of jaundice (in later periods, the appointment of the drug is less effective, the drug is not effective in developing hepatic coma and the cholestatic course of the disease);
- Acute prolonged hepatitis B and C, chronic active hepatitis B and C incl. with delta-agent, without signs of cirrhosis and with the appearance of signs of liver cirrhosis;
- viral (influenza, adenovirus,: enterovirus, herpetic, parotyptyps), viral-bacterial and mycoplasmic meningoencephalitis. Application
the drug is most effective in the first 4 days of the disease;
- Stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis, rusticulosarcomatosis), Kaposi's sarcoma. basal cell and squamous cell carcinoma of the skin, keratoacanthoma. chronic myeloid leukemia, histiocytosis from Laigerhans cells, subleukemic myelosis, essential thrombocythemia;
- Multiple sclerosis.
- viral conjunctivitis, keratoconjunctivitis. keratites, keratoyridocyclites, keratouveites.
Children from 1 year as part of complex therapy:
- Acute lymphoblastic leukemia in remission after the end of inductive chemotherapy (for 4-5 months of remission);
- juvenile respiratory papillomatosis of the larynx, starting from the next day after removal by papillomas.
DOSING MODE
Liffsrone В® injects / m, Into the focus or under the lesion, subconjunctival or place. Immediately before use, the contents of the ampoule (vial) are dissolved in water for injection or in a 0.9% solution of sodium chloride (in 1 ml - with a / m introduction and a focus, in 5 ml - with subconjunctival and local administration). The drug solution should be colorless, with weak opalescence. without sediment and foreign inclusions. The dissolution time should be about 10 minutes.
Intramuscular injection
In acute viral 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 course of treatment can be continued with the introduction of 1 million ME 2 times a week for 2 weeks. The course dose is 15-21 million ME.
In acute, protracted and chronic viral 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. If there is no effect, treatment can be extended to 3-6 months or after the end of 1-2 months of therapy, 2-3 similar courses should be performed at intervals of 1-6 months.
In chronic viral hepatitis B with delta-agent without signs of liver cirrhosis, the drug is administered 0.5-1 million ME per day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.
In chronic viral hepatitis B with delta-agent and signs of liver cirrhosis the drug is administered at 0.25-0.5 million ME per day 2 times a week for 1 month. When there are signs of decompensation, similar repeated courses are conducted at intervals of at least 2 meyayats.
In acute, protracted and chronically active hepatitis C without signs of cirrhosis, the drug is administered 3 million ME 3 times a week for 6-8 months. If there is no effect, prolong the treatment to 12 months. The repeated course of treatment - in 3-6 months.
In viral, viral-bacterial and mycoplasma meningoencephalitis, the drug is administered 1 million ME 2 times / day for 10 days as part of a complex therapy with antiviral and antibacterial chemotherapy drugs. The dose and treatment regimen are set individually, depending on the severity of the patient's condition.
With kidney cancer, the drug is used for 3 million IU / day for 10 days. Repeated courses of treatment (3-9 and more) are carried out with an interval of 3 weeks. The total dose of the drug is from 120 million IU to 300 million IU or more.
With hairy cell leukemia, the drug is administered daily for 3-6 million ME for 2 months. After the normalization of the hemogram, the daily dose of the drug is reduced to 1-2 million ME, then it is prescribed in a maintenance dose of 3 million ME 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million ME or more.
In acute lymphoblastic leukemia in children in remission after the end of inductive chemotherapy (for 4-5 months of remission) - 1 million ME each 1 time per week for 6 months, then 1 every 2 weeks for 24 months. Simultaneously, supportive chemotherapy is performed.
With malignant lymphomas and Kaposi's sarcoma, the drug is administered 3 million ME / day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and SCS. In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate IM in 3 mM medication and intramuscular 2 million ME for 10 days.
In patients with erythrodermic stage of fungal mycosis with an increase in body temperature above 39 В° C and in case of aggravation of the process, the drug should be discontinued. If the therapeutic effect is insufficient, after 10-14 days, a second course of therapy is prescribed. After achieving a clinical effect, a maintenance therapy of 3 million ME is prescribed once a week for 6-7 weeks.
In chronic myelogenous leukemia, the drug is administered 3 million ME daily or 6 million ME every other day. Term of treatment from 10 weeks to 6 months.
With histiocytosis from Langerhans cells, the drug is administered 3 million ME / day for 1 month. Repeated courses are conducted at 1-2-month intervals for 1-3 years.
With subleukemic myelosis and essential thrombocytopenia for the correction of hyperthrombocytosis, the drug is administered 1 million ME per day or every other day for 20 days.
In juvenile respiratory papillomatosis of the larynx, the drug is administered at a dose of 100-150 thousand ME per kg of body weight daily for 45-50 days, then at the same dose 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 ME each 1 time per week for 5-6 months . The total amount of the drug is 50-60 million ME.
Persons with a high pyrogenic reaction (body temperature of 39 В° C or higher) are advised to use paracetamol and indomethacin simultaneously.
Perifocal administration
With basal cell and squamous cell carcinoma, keratoacanthoma, the drug is injected under the lesion by 1 million ME 1 time / 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, a cryodestruction is performed.
Subconjunctival administration
In stromal keratitis and keratoiridocyclitis, subconjunctival injections of the drug are administered in a dose of 60,000 ME (0.5 ml volume) daily or every other day, depending on the severity of the process. Injections are performed under local anesthesia with a 0.5% solution of dicain. The course of treatment - from 15 to 25 injections.
Local application
To prepare a solution for topical application, 5 ml of a 0.9% solution of sodium chloride for injection are added to the contents of the ampoule (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 times / 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 paracetamol or indomethacin.
With topical application of the drug on the mucous membrane of the eye, conjunctival infection, hyperemia of the mucous membrane of the eye, single follicles, edema of the conjunctiva of the lower arch are possible.
When the drug is used, there may be deviations from the norm of laboratory indicators, which are manifested by leukopenia, lymphopenia, thrombocytopenia, an increase in the level of alanine amipotrapsferase, and alkaline phosphatase. For the timely detection of these abnormalities during therapy, general clinical blood tests should be repeated every 2 weeks, and biochemical - every 4 pedules. Typically, these changes are usually minor, asymptomatic and reversible.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- severe forms of allergic diseases;
- Pregnancy;
lactation period.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation.
SPECIAL INSTRUCTIONS
In case of severe adverse reactions or long-term preservation, at the doctor's discretion, a temporary dose reduction (with a decrease in the number of platelets to less than 50,000 cells per 1 Ојl of an absolute number of neutrophils less than 750 cells per 1 Ојl) or interruption of treatment reducing the number of platelets to less than 25,000 cells in 1 Ојl, the absolute number of neutrophils is less than 500 cells per 1 Ојl).
Influence on ability to drive vehicles, mechanisms
During the period of application of the drug to patients experiencing fatigue, drowsiness or disorientation, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Cases of overdose were not observed. Given that the active substance is interferon alpha-2b, then overdose may increase the severity of side effects.
Treatment: discontinuation of the drug; if necessary, conduct symptomatic therapy.
DRUG INTERACTION
Interferon alfa-2b is able to reduce the activity of P450 cytochrome and. therefore, interfere with the metabolism of cimetidine. phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some cytostatics. May enhance neurotoxic. myelotoxic or cardiotoxic effect 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).
Drinking alcohol during treatment is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 8 В° C. Shelf life - 3 years.
Not applicable after expiry date.
