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

Colds, Flu, Inflammation of the female reproductive organs, Respiratory tract infections, Urinary tract infections

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 children aged 3 to 6 years who are often and persistently ill.

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

Active ingredient

Interferon alpha-2b, Taurine

Composition

Composition per suppository:

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

excipients:

• “solid fat”,
• dextran 60000,
• macrogol 1500,
• polysorbate 80,
• emulsifier T2,
• sodium hydrocitrate,
• citric acid,
• purified water.

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How to take, the dosage

The drug can be used both vaginally and rectally. The method of administration, dose and duration of course depend on age and specific clinical situation. In adults and children over 7 years of age Genferon ^® Lite is used in a dose of 250,000 IU of interferon alfa-2b per suppository. In children under 7 years of age, including infants, it is safe to use the drug in a dose of 125,000 IU of interferon alfa-2b per suppository. In women who are 13-40 weeks pregnant, the drug is used in a dose of 250,000 IU of interferon alfa-2b per suppository.

Recommended doses and regimens:

Acute respiratory viral infections and other acute illnesses of viral nature in children: 1 suppository rectally 2 times daily at 12-hour intervals parallel to basic therapy for 5 days. If at the end of the 5-day treatment period the symptoms of the disease are not reduced or become more pronounced, the patient should consult a physician. On clinical indications it is possible to repeat the course of treatment after the 5-day interval.

Acute respiratory viral infections in frequently and persistently ill children aged 3 to 6 years: 1 suppository (125 000 IU) rectally twice daily with an interval of 12 hours for 10 days parallel to standard therapy. After completion of the basic period of treatment of acute respiratory viral infection it is possible to switch to the prophylactic scheme: 1 suppository (125 000 IU) rectally 1 time per night every other day during 3 weeks.

Chronic infectious-inflammatory diseases of viral aetiology in children over 7 years old: 1 suppository (250 000 IU) rectally 2 times a day with 12-hour intervals in parallel with standard therapy for 10 days. Then for 1-3 months, 1 suppository rectally at night every other day.

Acute infectious and inflammatory diseases of the urogenital tract in children: 1 suppository rectally 2 times a day at 12-hour intervals for 10 days with the prescribed and physician-controlled specific therapy.

Infectious inflammatory diseases of the urogenital tract in pregnant women: 1 suppository (250,000 IU) vaginally twice daily at 12-hour intervals for 10 days with physician-prescribed and supervised specific therapy.

Interaction

Genferon^® Lite is most effective as a component of complex therapy. When combined with antibacterial, fungicidal and antiviral drugs there is a mutual potentiation of action, which allows to achieve a high total therapeutic effect.

Special Instructions

Genferon ^® Lite does not affect the performance of potentially hazardous activities requiring particular attention and quick reactions (driving vehicles, machinery, etc.).

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Contraindications

Individual intolerance to interferon and other substances in the drug.

With caution: exacerbation of allergic and autoimmune diseases.

Side effects

The drug is well tolerated by patients. Very rare (incidence less than 1 per 10,000 cases): there are single reports of allergic reactions. These phenomena are reversible and disappear within 72 hours after discontinuation of administration. Continued treatment is possible after consultation with a physician.

To date there have been no severe or life-threatening side effects.

Overdose

Cases of overdose of Genferon ^® Lite have not been reported. In case of accidental simultaneous administration of more suppositories than prescribed by the doctor, further administration should be suspended for 24 hours, after which the treatment can be resumed according to the prescribed schedule.

Pregnancy use

The efficacy and safety of Genferon Lite in the second and third trimesters of pregnancy has been proved by clinical studies.

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

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