Leyfferon - instructions for use, dose, side effects, contraindications

In one ampoule or in one bottle contains: active substance - 0.5 million ME, 1 million ME, 3 million ME or 5 million ME of interferon alpha-2b human recombinant; Excipients: sodium chloride - 9.2 mg; sodium hydrophosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 2.74 mg; sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.37 mg; dextran with molecular weight from 30,000 to 40,000 (as a solution of "Reopoliglyukin" containing 100 mg / ml of dextran in a 0.9% solution of sodium chloride) - 8.0 mg; sorbitol (D-sorbitol) 3.0 mg, carbamide (urea) 0.1 mg.

Description:

Powder or porous mass of white color. Hygroscopic.

Pharmacotherapeutic group:Cytokine

ATX: & nbsp

L.03.A.B.05 Interferon alfa-2b

Pharmacodynamics:

Lifferon ® has antiviral, antitumor, immunomodulating activity.

Leyfferon® 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:

Layfferon® apply in complex therapy in adults:

- with acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period before 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 flow of the disease);

- with acute prolonged hepatitis B and C, chronic active hepatitis B and C, including with delta-agent, without signs of cirrhosis and with the appearance of signs of cirrhosis;

- in 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 kidney cancer of stage IV, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis, reticulosarcomatosis), Kaposi's sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myeloid leukemia, histiocytosis from Langerhans cells, subleukemic myelosis, essential thrombocythemia ;

- with multiple sclerosis,

- with viral conjunctivitis, keratoconjunctivitis, keratitis, keratoiridocyclitis, keratouveitis.

Layfferon® apply in complex therapy in children from 1 year:

- with acute lymphoblastic leukemia in remission after the end of induction chemotherapy (at 4-5 months of remission);

- with juvenile respiratory papillomatosis of the larynx, starting from the next day after removal by papillomas.

Contraindications:

- Phypersensitivity to the components of the drug;

- with severe forms of allergic diseases;

- during pregnancy and lactation.

Pregnancy and lactation:

The drug is contraindicated for use in pregnancy and lactation.

Dosing and Administration:

Lifferon® is injected intramuscularly, into the focus or under the lesion, subconjunctivalally or locally. Immediately before use, the contents of the ampoule (vial) are dissolved in water for injection or in 0.9% solution of sodium chloride (in 1 ml - with intramuscular injection and in the 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 to 1 million ME 2 times a day for 5-6 days, then the dose is reduced to 1 million ME per day and injected for another 5 days. If necessary (after control biochemical blood tests), the treatment course can be continued for 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.

In acute prolonged and chronic viral hepatitis B with the exception of the delta-agent and without signs of 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.

In chronic viral hepatitis B with delta-agent without signs of liver cirrhosis the drug is injected at 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 the signs of cirrhosis of the drug is administered to 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 not less than 2 months.

In acute chronic and chronic 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. Repeated course of treatment after 3-6 months.

In viral, viral-bacterial and mycoplasma meningoencephalitis the drug is administered to 1 million ME 2 times a day for 10 days, in combination with antiviral and antibacterial chemotherapy. 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 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 up to 300 million ME and more.

With hairy cell leukemia the drug is administered daily for 3-6 million. ME during 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 drug is 420-600 million ME or more.

In acute lymphoblastic leukemia in children in the remission period after the end of induction chemotherapy (at 4-5 months of remission) - 1 million ME 1 time a 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 to 3 million ME per day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungal mycosis, primary reticulosis and reticulosarcomatosis, it is advisable to alternate intramuscular injection of the drug to 3 million ME and intrafocal - 2 million ME within 10 days.

In patients with erythrodermal stage of fungal mycosis when the temperature rises above 39 ° C and if the process worsens, 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 ME once a week for 6-7 weeks.

In chronic myelogenous leukemia the drug is administered to 3 million ME daily or 6 million ME in one day. The treatment period is from 10 weeks to 6 months.

With histiocytosis from Langerhans cells the drug is administered to 3 million ME daily for 1 month. Repeated courses with 1-2-month intervals for 1-3 years.

With subleukemic myelosis and essential thrombocythemia for the correction of hyperthrombocytosis - 1 million ME daily or after 1 day for 20 days.

With juvenile respiratory papillomatosis of the larynx the drug is administered to 0.1-0.15 million ME per kg of body weight daily for 45-50 days, then in 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 a pyramidal syndrome 3 times a day, with cerebellar syndrome - 1-2 times a day for 10 days followed by the introduction of 1 million ME 1 time per week for 5-6 months. The total amount of the drug is 50-60 million ME.

In persons with a high pyrogenic reaction (39 ° C and above), the simultaneous use of paracetamol or indomethacin is recommended for the administration of the drug.

Perifocal administration

With basal cell and squamous cell carcinoma, keratoacanthoma the drug is injected under the lesion for 1 million ME 1 time per day every day 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

With stromal keratitis, keratoiridocyclitis, keratouveitis prescribe subconjunctival injections of the drug in a dose of 60 thousand. ME 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 a 0.5% solution of dicain. The course of treatment - from 15 to 25 injections.

Local application

For topical application, the contents of the ampoule (vial) of the drug with an activity of 1 million ME dissolved in 5 ml of sodium chloride solution 0.9% for injection. 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 bottle with a stopper and store the solution in the refrigerator at (4-10) ° C for no more than 12 hours.

With conjunctivitis and superficial keratitis on the conjunctiva of the affected eye, 2 drops of solution are applied 6-8 times a day. With the disappearance of inflammatory phenomena, the number of installations is reduced to 3-4 times per day. The course of treatment is 2 weeks.

Side effects:

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.

When topical application of the drug on the mucosa of the eye is possibleconjunctival infection, hyperaemia of the mucous membrane of the eye, single follicles, edema of the conjunctiva of the lower arch.

When the drug is used, there may be deviations from the norm of laboratory indicators, manifested by leukopenia, lymphopenia, thrombocytopenia, an increase in the level of alanine aminotransferase, 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 weeks. Typically, these changes are usually minor, asymptomatic and reversible.

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: cancellation of the drug; if necessary, conduct symptomatic therapy.

Interaction:Interferon alfa-2b is able to reduce the activity of P450 cytochrome and, consequently, interfere with the metabolism of cimetidine, phenytoin, dipyridamole, theophylline, diazepam, propraiolol, warfarin, and some cytotoxic agents.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).

Drinking alcohol during treatment is not recommended.

Special instructions:In case of severe adverse reactions or persistence for a long time, 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 μl, an absolute number of neutrophils less than 750 cells per 1 μl) or interruption of treatment reducing the number of platelets to less than 25,000 cells in 1 μl, the absolute number of neutrophils is less than 500 cells per 1 μl).

Effect on the ability to drive transp. cf. and fur: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 requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Lyophilizate for the preparation of a solution for intramuscular, subconjunctival administration and instillation in the eye of 0.5 million ME; 1 million ME; 3 million ME; 5 million ME.

Packaging:

Lyophilizate for the preparation of solution for intramuscular, subconjunctival administration and instillation into the eye.

In ampoules of 0.5 million ME; 1 million ME; 3 million ME; 5 million ME; 5 ampoules in a cell pack of a PVC film (PVC); 1 or 2 cell packs, together with the Instruction for use and a knife ampoule or scarifier, in a cardboard bundle. If the ampoules have a break ring or break point, the scarifier is not put into the package.

In glass bottles of 0.5 million ME; 1 million ME; 3 million ME; 5 million ME. The bottles are sealed with rubber stoppers and rolled up with aluminum caps; 5 bottles in a PVC packaging; 1 pack with instructions for use in a cardboard box.

Storage conditions:Store in a dark place at a temperature not exceeding 8 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Not applicable after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001989

Date of registration:16.09.2011 / 02.02.2017

Expiration Date:Unlimited

The owner of the registration certificate:VECTOR-MEDICA, CJSC VECTOR-MEDICA, CJSC Russia

Manufacturer: & nbsp

VECTOR-MEDICA, CJSC Russia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Layfferon (Lifferon®)