Genferon Lite suppositories vaginal/rectal, 250mg+5mg 10pcs

Composition

Composition per suppository:

• active ingredients: human recombinant Interferon alfa-2b (rfIFN-a2b – – 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.

Pharmacological action

of GENFERON® LIGHT is a combined drug, the action of which is due to the components that make up its composition. It has a local and systemic effect.

Genferon ® Light contains recombinant human Interferon alfa-2b, produced by a strain of the bacterium Escherichia coli, into which the human Interferon alfa-2b gene has been genetically engineered.

Interferon alfa-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 primarily by an increase in cell-mediated responses 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 by activating CD8+ killer T cells, NK cells (natural killer cells), enhancing B-lymphocyte differentiation and antibody production, activating the monocyte-macrophage system and phagocytosis, and increasing the expression of molecules of the main type I histocompatibility complex, which increases the probability of recognition of infected cells by immune system cells.

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

Taurine contributes to the normalization of metabolic processes and tissue regeneration, has a membrane-stabilizing and immunomodulatory effect. 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 preserve the biological activity of interferon, enhancing the therapeutic effect of the drug.

Pharmacokinetics

With rectal use of the drug, high bioavailability (more than 80%) of interferon is noted, and therefore both local and pronounced systemic immunomodulatory effects are achieved; with intravaginal use, due to the high concentration in the focus of infection and fixation on mucosal cells, 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 reached 5 hours after use of the drug. The main route of alpha-interferon elimination is renal catabolism. The half-life is 12 hours, which makes it necessary to use the drug 2 times 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 specific therapy prescribed and controlled by a doctor.

Use during pregnancy and lactation

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 that make up 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 discontinuation of use. Continuation of treatment is possible after consultation with a doctor.

So far, no severe or life-threatening side effects have been observed.

Interaction

Genferon ® Light is most effective as a component of complex therapy. When combined with antibacterial, fungicidal and antiviral drugs, mutual potentiation of the action is observed, which makes it possible to achieve a high total therapeutic effect.

How to take, course of use and dosage

The drug can be used both vaginally and rectally. The method of use, dose and duration of the course depend on the age and specific clinical situation. In adults and children over 7 years of age, Genferon ® Light is administered at 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 at a dose of 125,000 IU of Interferon alfa-2b per suppository. In women who are at 13-40 weeks of pregnancy, the drug is used in a dose of 250,000 IU of Interferon alfa-2b per suppository.

Recommended doses and treatment regimens:

Acute respiratory viral infections and other acute viral diseases in children: 1 suppository rectally 2 times a day with a 12-hour interval in parallel with the main therapy for 5 days. If after the 5-day treatment period, the symptoms of the disease do not decrease or become more pronounced, the patient should consult a doctor. According to clinical indications, it is possible to repeat the course of treatment after a 5-day interval.

Acute respiratory viral infections in frequently and long-term ill children aged 3 to 6 years: 1 suppository (125,000 IU) rectally 2 times a day with an interval of 12 hours for 10 days in parallel with standard therapy. After completing the main period of treatment for acute respiratory viral infection, it is possible to switch to a preventive scheme: 1 suppository (125,000 IU) rectally 1 time at night every other day for 3 weeks.

Chronic infectious and inflammatory diseases of viral etiology in children over 7 years of age: 1 suppository (250,000 IU) rectally 2 times a day with a 12-hour interval 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 with a 12-hour interval for 10 days against the background of specific therapy prescribed and controlled by a doctor.

Infectious and inflammatory diseases of the urogenital tract in pregnant women: 1 suppository (250,000 IU)  vaginally 2 times a day with a 12-hour interval for 10 days against the background of a specific therapy prescribed and controlled by a doctor.

Infectious and inflammatory diseases of the urogenital tract in women: 1 suppository (250,000 IU) vaginally or rectally (depending on the nature of the disease) 2 times a day with a 12-hour interval for 10 days against the background of specific therapy prescribed and controlled by a doctor. With prolonged forms,3 times a week every other day,1 suppository for 1-3 months.

Overdose

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

Special instructions

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

Form of production

Vaginal and rectal suppositories 125,000 IU+5 mg and 250,000 IU+5 mg.

5 suppositories in a contour cell package made of aluminum foil or polyvinyl chloride film. 2 contour cell packages together with instructions for use in a cardboard pack.

Storage conditions

At a temperature of 2-8 °C

Shelf life

2 years

Active ingredient

Interferon alfa-2b, Taurine

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Purpose

Pregnant women in the second and third trimester as prescribed by a doctor, Children over 7 years of age, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Cold, Flu, Urinary Tract Infections, Female Genital Infections, Respiratory Tract Infections