Генферон® Light

General characteristics. Structure:

Active components: 125 000 ME or 250 000 ME of interferon alpha 2b, 0,005 g of taurine.

Auxiliary components: "solid fat", a dextran 60000, a macrogoal 1500, polysorbate 80, T2 emulsifier, sodium hydrocitrate, the citric acid, water purified – enough before receiving suppository weighing 0,8 g.

The immunomodulatory, antiviral, antibacterial, anti-proliferative, regenerating agent.

Pharmacological properties:

Pharmacodynamics. Immunobiological properties. Генферон® Light — the combined drug which effect is caused by the components which are its part. Has local and systemic effect.

Recombinant human interferon alpha 2b, Escherichia coli developed by a strain of a bacterium into which methods of genetic engineering entered a gene of interferon alpha 2b the person is a part of the drug Genferon® Light. Interferon alpha 2b renders antiviral, immunomodulatory, anti-proliferative and antibacterial action. The antiviral effect is mediated by activation of a number of the desmoenzymes inhibiting replication of viruses. Immunomodulatory action is shown, first of all, by strengthening of cell-mediated reactions of immune system that increases efficiency of an immune response concerning viruses, the intracellular parasites and cells which underwent tumoral transformation. It is reached due to activation of CD8+ of T-killers, NK cells (natural killers), strengthening of a differentiation of V-lymphocytes and products of antibodies by them, activation of monocytic and macrophagic system and phagocytosis, and also increase in an expression of molecules of the main complex of histocompatability of the I type that increases probability of recognition of the infected cells cells of immune system. Activation under the influence of interferon of the leukocytes which are contained in all layers of a mucous membrane provides their active participation in elimination of the pathological centers; besides, due to influence of interferon recovery of products of secretory immunoglobulin A is reached. The antibacterial effect is mediated by the reactions of immune system strengthened under the influence of interferon.

Taurine contributes to normalization of metabolic processes and an angenesis, possesses membrane stabilizing and immunomodulatory action. Being strong antioxidant, taurine directly interacts with active forms of oxygen which excess accumulation promotes development of pathological processes. Taurine promotes preservation of biological activity of interferon, strengthening therapeutic effect of use of drug.

Pharmacokinetics. At rectal administration of drug high bioavailability (more than 80%) of interferon in this connection both the local, and expressed systemic immunomodulatory action is reached is noted; at intravaginalny use due to high concentration in the center of an infection and fixing on cells of a mucous membrane of a vagina the expressed local antiviral, anti-proliferative and antibacterial effect, at the same time systemic action due to the low soaking-up ability of a mucous membrane of a vagina insignificant is reached. Cmax of interferon in blood serum is reached in 5 h after administration of drug. The main way of removal is the renal catabolism. T1/2 makes 12 h that causes need of use of drug 2 times a day.

At intranasal use due to high concentration in the center of an infection the antiviral and immunostimulating effect expressed local is reached.

System absorption of drug is insignificant — low bioavailability of HP at intranasal introduction is connected with functioning of special family of proteins from 25 proteins which are a part of a mucous membrane of a nasal cavity and controlling transport of all molecular and cellular objects getting through mucous.

At the same time, a quantity of drug gets to a system blood stream at the expense of what the system immunomodulatory effect is reached.

Indications to use:

As a component of complex therapy – for treatment of acute respiratory viral infections and other infectious diseases of a bacterial and virus etiology at children.

For treatment of infectious and inflammatory diseases of an urogenital path at children and women, including pregnant women.

Route of administration and doses:

Drug can be used both vaginalno, and rektalno. The way of introduction, a dose and duration of a course depend on age, a specific clinical situation and are defined by the attending physician.

At adults and children 7 years are more senior than Genferon® Light apply in a dose of 250 000 ME of interferon alpha 2b on suppository.

At children up to 7 years use of drug in a dose of 125 000 ME of interferon alpha 2b on suppository is safe.

At the women who are on 13-40 week of pregnancy, drug is used in a dose of 250 000 ME of interferon alpha 2b on suppository.

The recommended doses and the modes of treatment. Acute respiratory viral infections and other acute diseases of the virus nature at children: on 1 suppository rektalno 2 times a day with a 12-hour interval parallel to the main therapy within 5 days. At preservation of symptomatology the course of treatment repeats after a 5-day interval.

Chronic infectious and inflammatory diseases of a virus etiology at children: on 1 suppository rektalno 2 times a day with a 12-hour interval parallel to standard therapy within 10 days. Then within 1-3 months – on 1 suppository rektalno for the night every other day.

Acute infectious and inflammatory diseases of an urogenital path at children: on 1 suppository rektalno 2 times a day with a 12-hour interval within 10 days.

Infectious and inflammatory diseases of an urogenital path at pregnant women: on 1 suppository vaginalno 2 times a day with a 12-hour interval within 10 days.

Infectious and inflammatory diseases of an urogenital path at women: on 1 suppository (250 000 ME) vaginalno or rektalno (depending on the nature of a disease) 2 times a day with a 12-hour interval within 10 days. At long forms 3 times a week every other day on 1 suppository within 1-3 months.

Features of use:

Use during pregnancy and a lactation.  Clinical trials proved efficiency and safety of use of the drug Genferon® Light for the women who are on 13–40 week of pregnancy. Use in the I trimester of pregnancy is contraindicated. Has no restrictions to use in the period of a lactation.

Генферон® Light does not influence performance of potentially dangerous types of activity requiring special attention and bystry reactions (control of vehicles, the machine equipment, etc.).

Side effects:

Drug is well transferred by patients. Very seldom (frequency less than 1 on 10 000 cases): there are single messages on cases of development of allergic reactions. These phenomena are reversible and disappear within 72 hours after the introduction termination. Continuation of treatment is possible after consultation with the doctor. So far heavy or life-threatening by-effects were not observed.

Interaction with other medicines:

Генферон® Light it is most effective as a component of complex therapy. At a combination to antibacterial, fungicidal and antiviral drugs mutual potentiation of action is observed that allows to achieve high cooperative therapeutic effect.

Contraindications:

Individual intolerance of interferon and other substances which are a part of drug. I trimester of pregnancy.

With care. Exacerbation of allergic and autoimmune diseases.

Overdose:

Cases of overdose of Genferona® Light are not registered. At accidental one-time introduction of bigger number of suppositories, than it was offered the doctor, it is necessary to suspend further introduction for 24 hours then treatment can be resumed according to the ordered scheme.

Storage conditions:

At a temperature from 2 to 8 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Suppositories vaginal and rectal 125 000 ME+5 of mg, 250 000 ME+5 of mg. On 5 suppositories in a blister strip packaging from aluminum foil or a film polyvinyl chloride. 1 or 2 blister strip packagings together with the application instruction in a pack from a cardboard.