Genferon Light 125 IU + 5 mg 10 pcs

Biocad, Russia

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Product Overview

Structure

Composition per suppository:

 

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

 

Excipients:
  • "Hard fat"
  • dextran 60,000
  • macrogol 1500,
  • polysorbate 80,
  • emulsifier T2,
  • sodium hydrocytrate,
  • lemon acid,
  • purified water.

pharmachologic effect

GENFERON ®  LIGHT - a combined drug, the effect of which is due to the components that make up its composition. It 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 has been introduced by genetic engineering.

Interferon alfa-2b has an antiviral, immunomodulatory, antiproliferative and antibacterial effect. 

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

This is achieved through the activation of CD8 + T-killers, NK cells (natural killers), 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 main histocompatibility complex of type I, which increases the likelihood recognition of infected cells by cells of the immune system. 

Activation of leukocytes 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 reactions of the immune system enhanced by the influence of interferon.

Taurine contributes to the normalization of metabolic processes and tissue regeneration, has a membrane-stabilizing and immunomodulating 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 administration of the drug, a high bioavailability (over 80%) of interferon is noted, in connection with which 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 the cells of the mucous membrane, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect due to the low absorption capacity of the vaginal mucosa is insignificant. 

The maximum concentration of interferon in blood serum is reached 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 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 often and long-term sick 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.

Pregnancy and lactation

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

The safety of 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 rarely (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 serious 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 action is observed, which allows to achieve a high total therapeutic effect.

How to take, course of administration and dosage

The drug can be used both vaginally and rectally. The route of administration, dose and duration of the course depend on age and the specific clinical situation. In adults and children over 7 years of age, Genferon ®  Light is used at a dose of 250,000 IU of interferon alpha-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 alpha-2b per suppository. In women at 13-40 weeks of gestation, the drug is used at a dose of 250,000 IU of interferon alpha-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 a 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, a repeat course of treatment after a 5-day interval is possible.

Acute respiratory viral infections in often 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 the completion of the main treatment period for acute respiratory viral infection, a transition to the preventive regimen is possible: 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 within 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 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 protracted forms 3 times a week every other day, 1 suppository for 1-3 months.

Overdose

Cases of overdose of Genferon ® Light are not registered. In case of accidental simultaneous administration of a larger number of suppositories than was prescribed by a doctor, further administration 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 execution of potentially hazardous activities that require special attention and quick reactions (driving vehicles, machinery, etc.).

Release form

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

On 5 suppositories in a blister strip packaging from aluminum foil or polyvinyl chloride film. 2 blister packs along with instructions for use in a pack of cardboard.

Storage conditions

At a temperature of 2–8 ° C

Shelf life

2 years

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