Lifferon lyophilizate for intramuscular, subconjunctival injection and eye drops 1mlnIU vials, 5pcs

Composition

Lyophilizate for the preparation of a solution for intramuscular, subconjunctival use and instillation into the eye in the form of a powder or a porous mass of white color, hygroscopic.

Auxiliary substances:

sodium chloride – 9.2 mg,

sodium hydrogen phosphate, dodecahydrate (sodium disodium phosphate 12-water) – 2.74 mg,

sodium dihydrogen phosphate dihydrate (sodium phosphate odnosemjannyj 2-water) – 0.37 mg,

dextran with a M. M. from 30000 to 40000 (in the form of a solution, “Reopoliglyukin” containing 100 mg/1 ml dextran in 0.9% solution of sodium chloride) 8 mg,

sorbitol (D-sorbitol) – 3 mg,

urea (carbamide) – 0.1 mg.

Pharmacological action of

the drugs dactilyfera® has antiviral, antitumor, immunomoduliruuchee activity. Pharmacokineticalaifferon ® undergoes degradation during parenteral use, is partially excreted unchanged, mainly through the kidneys. Like all interferons, the drug can cause the appearance of interferon antibodies in individuals with prolonged use, which leads to a decrease in the therapeutic effect.

Indications

Adults in complex therapy:

• acute viral hepatitis In moderate and severe forms at the beginning of the icteric period before the 5th day of jaundice (later the drug less effective; the drug is not effective for developing hepatic coma and cholestatic disease);
• prolonged acute hepatitis b, chronic active hepatitis b and C, including with Delta-agent without signs of cirrhosis and signs of cirrhosis of the liver;
• viral (flu, adenovirus, : enterovirus, herpes, parotitic), viral-bacterial and mycoplasmae of meningoencephalitis. The use of the drug is most effective in the first 4 days of the disease;
• stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (fungal mycosis, primary reticulosis, rsticulosarcomatosis), 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, keratoiridocyclites, and keratouveites.

Children from 1 year of age as part of complex therapy:

• acute lymphoblastic leukemia in remission after the end of inductive chemotherapy (for 4-5 months of remission);
• juvenile respiratory laryngeal papillomatosis, starting from the next day after the removal of papillomas.

Contraindications

• Hypersensitivity to the components of the drug;
• severe forms of allergic diseases;
• pregnancy;
• lactation.

Side effects

With parenteral use of the drug, chills, fever, fatigue, headache, malaise, flu-like syndrome are possible. These side effects are partially relieved by paracetamol or Indometacin. When the drug is applied topically on the eye mucosa, conjunctival infection, hyperemia of the eye mucosa, single follicles, and edema of the conjunctiva of the lower arch are possible. When using the drug, deviations from the norm of laboratory parameters are possible, manifested by leukopenia, lymphopepia, thrombocytopenia, an increase in the level of alanine amypotrapsferase, ALP. For timely detection of these abnormalities during therapy, general clinical blood tests should be repeated every 2 weeks, and biochemical blood tests should be repeated every 4 pedels. Generally, these changes are usually minor, asymptomatic, and reversible.

Interaction

Interferon alfa-2b is able to reduce the activity of cytochrome P 450 and therefore interfere with the metabolism of cimetidine. phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, some cytostatics. May increase neurotoxic effects. myelotoxic or cardiotoxic effects of drugs prescribed earlier or simultaneously with it. Co-use with CNS depressants, immunosuppressive drugs (including corticosteroids) should be avoided. Alcohol consumption during treatment is not recommended.

How to take, course of use and dosage

of Liffsron® is administered intravenously, In the lesion or under the lesion, subconjunctivally or topically. Immediately before use, the contents of the ampoule (vial) are dissolved in water for injection or in 0.9% sodium chloride solution (in 1 ml – with intravenous use and in the focus, in 5 ml – with subconjunctival and local use). The solution of the drug should be colorless, with a weak opalescence. free of sediment and foreign inclusions. The dissolution time should be about 10 minutes. In / m vvedeniyepri acute viral hepatitis B drug is administered 1 million IU 2 times / day for 5-6 days, then the dose is reduced to 1 million ME/day and enter for another 5 days. If necessary (after control biochemical blood tests), the course of treatment can be continued with the introduction of 1 million IU 2 times a week for 2 weeks. The course dose is 15-21 million ME. In acute, prolonged and chronic viral hepatitis B, with the exception of delta infection and without signs of cirrhosis of the liver, the drug is administered in 1 dose million IU 2 times a week for 1-2 months. In the absence of an effect, treatment can be extended to 3-6 months or after the end of 1-2 months of therapy,2-3 similar courses can be carried out with an interval of 1-6 months. In chronic viral hepatitis B with a delta agent without signs of cirrhosis of the liver, the drug is administered 0.5-1 times million IU per day 2 times a week for 1 month. Repeat the course of treatment in 1-6 months. In chronic viral hepatitis B with a delta agent and signs of cirrhosis of the liver, the drug is administered at 0.25-0.5 million IU per day 2 times a week for 1 month. If signs of decompensation appear, similar repeated courses are performed at intervals of at least 2 months. In acute, prolonged and chronically active hepatitis C without signs of cirrhosis of the liver, the drug is administered in 3 doses million IU 3 times a week for 6-8 months. If there is no effect, the treatment should be extended to 12 months. Repeated course of treatment – in 3-6 months. For viral, viral-bacterial and mycoplasma meningoencephalitis, the drug is administered in 1 dose million IU 2 times / day for 10 days as part of 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. For kidney cancer, the drug is used for 3 million rubles. IU / day for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total dose of the drug is from 120 million mg. IU up to 300 million. IU or more. In case of hairy cell leukemia, the drug is administered daily for 3-6 hours. million IU within 2 months. After normalization of the hemogram, the daily dose of the drug is reduced to 1-2 million ME, then prescribed in a maintenance dose of 3 million IU 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million. IU and more. In acute lymphoblastic leukemia in children in remission after the end of inductive chemotherapy (for 4-5 months of remission) – 1 million IU once a week for 6 months, then once every 2 weeks for 24 months. At the same time, maintenance chemotherapy is performed. For malignant lymphomas and Kaposi’s sarcoma, the drug is administered in 3 doses million ME/day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and corticosteroids. In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate the intravenous use of 3 million mg of the drug. IU and intraocular po 2 million IU within 10 days. In patients with an erythrodermic stage of fungal mycosis, if the body 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 therapy is prescribed after 10-14 days. After achieving a clinical effect, maintenance therapy is prescribed for 3 million IU once a week for 6-7 weeks. In chronic myeloid leukemia, the drug is administered in 3 million units. IU daily or 6 million IU every other day. The duration of treatment is from 10 weeks to 6 months. In histiocytosis from Langerhans cells, the drug is administered in 3 doses million ME/day within 1 month. Repeated courses are conducted at 1-2-month intervals for 1-3 years. In case of subleukemic myelosis and essential thrombocytopenia, the drug is administered in 1 million units to correct hyperthrombocytosis. IU daily or every other day for 20 days. In juvenile respiratory laryngeal papillomatosis, the drug is administered at 100-150 thousand rubles. IU 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. In multiple sclerosis, the drug is prescribed for 1 million IU with pyramidal syndrome 3 times / day, with cerebellar syndrome-1-2 times/day for 10 days, followed by the introduction of 1 million IU once a week for 5-6 months. The total amount of the drug is 50-60 million ME. Concomitant use of paracetamol and Indometacin is recommended for persons with a high pyrogenic reaction (body temperature 39°C or higher) to the drug use. Perifocal injectio Nin basal cell and squamous cell carcinoma, keratoacanthoma, the drug is administered under the lesion center for 1 million IU 1 time / day daily for 10 days. In the case of severe local inflammatory reactions, the injection under the lesion is carried out after 1-2 days. At the end of the course, cryodestruction is performed if necessary. Subconjunctival injectio Nin stromal keratitis and keratoiridocyclitis, subconjunctival injections of the drug are prescribed in a dose of 60 thousand rubles.ME (in volume 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% dicaine solution. The course of treatment is from 15 to 25 injections. Topical applicatio Nto prepare a solution for topical application to the contents of the ampoule (1 million IU add 5 ml of 0.9% sodium chloride solution for injection. In case of storage of the drug solution, it is necessary, following the rules of asepsis and antiseptics, to transfer the contents of the ampoule to a sterile bottle with a stopper and store the solution in the refrigerator at 4-10°C. From no more than 12 hours. For conjunctivitis and superficial keratitis,2 drops of the solution are applied to the conjunctiva of the affected eye 6-8 times a day. As the inflammatory phenomena disappear, the number of instillations is reduced to 3-4 times/day. The course of treatment is 2 weeks.

Overdose

No cases of overdose were observed. Given that the Active ingredient is Interferon alfa-2b, an overdose may increase the severity of side effects. Treatment: discontinuation of the drug; if necessary, conduct symptomatic therapy.

Special instructions

In case of severe adverse reactions or their persistence for a long time, at the discretion of the doctor, a temporary dose reduction is allowed (if the platelet count decreases to less than 50,000 cells per 1 µl. the absolute number of neutrophils is less than 750 cells per 1 µl) or interruption of treatment (if the platelet count decreases to less than 25,000 cells per 1 µl, the absolute number of neutrophils is less than 500 cells per 1 µl). Influence on the ability to drive vehicles, mechanisms During the use of the drug in patients experiencing fatigue, drowsiness or disorientation, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

The drug should be stored in a place protected from light and inaccessible to children at a temperature not exceeding 8°C. Not applicable after the expiration date.

Shelf

life is 3 years.

Active ingredient

Interferon alfa-2b

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection