Genferon Light, vaginal and rectal suppositories 125000 me+5 mg 10 pcs

Genferon ^® Lite is a combined preparation, the effect of which is caused by its constituent components. The preparation contains recombinant human interferon alfa-2b produced by Escherichia coli bacteria strain which has been genetically engineered with human interferon alfa-2b gene.

Interferon alpha-2b has antiviral, immunomodulatory, antiproliferative and antibacterial action.

The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit viral replication. Immunomodulatory action is first of all manifested by strengthening of cell-mediated reactions of immune system which increases the effectiveness of immune response against viruses, intracellular parasites and cells which have undergone tumor transformation.

This is achieved through activation of CD8+ T-helpers, NK-cells (natural killer cells), increasing differentiation of В-lymphocytes and their production of antibodies, activation of monocytic-macrophage system and phagocytosis as well as increasing the expression of histocompatibility complex type I molecules, which increases the recognition of infected cells by the immune system.

The activation under the influence of interferon of leukocytes contained in all layers of the mucous membrane provides their active participation in the liquidation of pathological foci; besides, due to the influence of interferon the restoration of the production of secretory immunoglobulin A is achieved. Antibacterial effect is mediated by reactions of the immune system enhanced under the influence of interferon.

Taurine promotes normalization of metabolic processes and tissue regeneration, has a membrane stabilizing and immunomodulatory action. As a strong antioxidant, taurine directly interacts with reactive oxygen species, the excessive accumulation of which contributes to pathological processes.

Taurine helps to preserve the biological activity of interferon, increasing the therapeutic effect of the drug.

Pharmacokinetics

In rectal administration of the drug a high bioavailability (more than 80%) of interferon is noted due to which both local and expressed systemic immunomodulatory effects are achieved; At intravaginal application due to high concentration in the focus of infection and fixation on the cells of the mucous membrane a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect is insignificant due to the low absorption capacity of the vaginal mucosa.

The maximum concentration of interferon in blood serum is achieved 5 hours after administration of the drug. The main way of excretion of α-interferon is renal catabolism. The elimination half-life is 12 hours, which necessitates using the drug twice a day.

Indications

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

– As a component of complex therapy – for the treatment and prevention of repeated episodes of acute respiratory viral infections in frequently and long-term ill children aged 3 to 6 years.

–
For the treatment of infectious and inflammatory diseases of the urogenital tract in
children and women, including pregnant women, against the background of prescribed and controlled
doctor of specific therapy.

Pharmacological effect

GENFERON® LIGHT is a combination drug, the effect of which is determined by the components included in its composition. Has local and systemic effects.

The composition of the drug Genferon® Light includes recombinant human interferon alpha-2b, produced by a strain of the bacterium Escherichia coli, into which the human interferon alpha-2b gene was introduced using genetic engineering methods.

Interferon alpha-2b has antiviral, immunomodulatory, antiproliferative and antibacterial effects.

The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit viral replication. The immunomodulatory effect is manifested, first of all, by enhancing cell-mediated reactions of the immune system, which increases the effectiveness of the immune response against viruses, intracellular parasites and cells that have undergone tumor transformation.

This is achieved through the activation of CD8+ T killer cells, NK cells (natural killer cells), increased differentiation of B lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as increased expression of molecules of the major histocompatibility complex type I, which increases the likelihood of recognition of infected cells by cells of the immune system.

Activation under the influence of interferon of leukocytes contained in all layers of the mucous membrane ensures their active participation in the elimination of pathological foci; in addition, due to the influence of interferon, restoration of the production of secretory immunoglobulin A is achieved. The antibacterial effect is mediated by reactions of the immune system, enhanced under the influence of interferon.

Taurine helps normalize metabolic processes and tissue regeneration, has membrane-stabilizing and immunomodulatory effects. Being a strong antioxidant, taurine directly interacts with reactive oxygen species, the excessive accumulation of which contributes to the development of pathological processes.

Taurine helps maintain the biological activity of interferon, enhancing the therapeutic effect of the drug.

Pharmacokinetics

With rectal administration of the drug, high bioavailability (more than 80%) of interferon is observed, and therefore both local and pronounced systemic immunomodulatory effects are achieved; when used intravaginally, due to the high concentration at the site of infection and fixation on the cells of the mucous membrane, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect is insignificant due to the low absorption capacity of the vaginal mucosa.

The maximum concentration of interferon in the blood serum is achieved 5 hours after administration of the drug. The main route of excretion of α-interferon is renal catabolism. The half-life is 12 hours, which necessitates the use of the drug 2 times a day.

Special instructions

Genferon® Light does not affect the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, machinery, etc.).

Active ingredient

Interferon alpha-2b, Taurine

Composition

Composition per suppository:

active ingredients: human recombinant interferon alpha-2b (rhIFN-α2b) – 125,000 IU or 250,000 IU; taurine – 0.005 g;

excipients:
“hard fat”
dextran 60000,
macrogol 1500,
polysorbate 80,
emulsifier T2,
sodium hydrogen citrate,
citric acid,
purified water.

Pregnancy

Clinical studies have proven the effectiveness and safety of using Genferon Light in the second and third trimesters of pregnancy.

The safety of using the drug in the first trimester of pregnancy has not been studied.

Contraindications

Individual intolerance to interferon and other substances included in the drug.

With caution: exacerbation of allergic and autoimmune diseases.

Side Effects

The drug is well tolerated by patients. Very rare (frequency less than 1 in 10,000 cases): there are isolated reports of cases of allergic reactions. These phenomena are reversible and disappear within 72 hours after cessation of administration. Continuation of treatment is possible after consultation with a doctor.

To date, no severe or life-threatening
side effects.

Interaction

Genferon® Light is most effective in
as a component of complex therapy. When combined with antibacterial,
mutual potentiation is observed with fungicidal and antiviral drugs
actions, which allows you to achieve a high total therapeutic effect.

Overdose

There are no cases of overdose of Genferon® Light
registered. In case of accidental simultaneous administration of a larger number
suppositories than prescribed by the doctor, further
administration for 24 hours, after which treatment can be resumed as prescribed
scheme.

Storage conditions

At 2–8 °C

Shelf life

2 years

Manufacturer

Biocad, Russia