Genferon Light - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspVaginal and rectal suppositories

Composition:

1 suppository for dosages of 125,000 IU + 5 mg, 250,000 IU + 5 mg respectively contains:

active substances: interferon alfa-2b - 125 000 ME, 250 000 ME; taurine - 0,005 g;

auxiliary substances: "solid fat", dextran 60000, macrogol 1500, polysorbate 80, emulsifier T2, sodium hydrocitrate, citric acid, purified water - sufficient amount to obtain a suppository with a mass of 0.8 g.

Description:

White or white with a yellowish hue, the color of the suppository cylindrical shape with a pointed end, on the longitudinal cut is uniform. On the cut, an air rod or a funnel-shaped depression is allowed.

Pharmacotherapeutic group:Immunomodulating agents, interferons

ATX: & nbsp

Interferon alfa-2b

Pharmacodynamics:

GENFERON® LITE - a combined drug, the effect of which is due to the components that make up its composition. Has a local and systemic effect.

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

Interferon alfa-2b has antiviral, immunomodulating, antiproliferative and antibacterial action.The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit the replication of viruses. Immunomodulatory effect is manifested, first of all, by intensification of cell-mediated immune system reactions, which increases the effectiveness of the immune response against viruses, intracellular parasites and cells that underwent tumor transformation. This is achieved through activation Cd8+ T-killers, NKcells (natural killers), enhancing the differentiation of B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as increasing the expression of the molecules of the main histocompatibility complex of type I, which increases the probability of recognition of infected cells by immune system cells. Activation under the influence of interferon 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, the production of secretory immunoglobulin A is restored. The antibacterial effect is mediated by immune system reactions, enhanced by 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 the active forms of oxygen, the excessive accumulation of which contributes to the development of pathological processes. Taurine promotes the preservation of the biological activity of interferon, enhancing the therapeutic effect of the drug.

Pharmacokinetics:

When rectal administration of the drug high bioavailability (more than 80%) of interferon is noted, in connection with which both local and expressed systemic immunomodulatory effect is achieved; when intravaginal application due to the high concentration in the focus of infection and fixation on the cells of the mucosa, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic action due to the low absorption capacity of the mucous membrane of the vagina is insignificant. The maximum concentration of interferon in the serum is reached 5 hours after the administration of the drug. The main way to remove α-interferon is renal catabolism.The half-life is 12 hours, which necessitates the use of 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.

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

Contraindications:

Individual intolerance to interferon and other substances that make up the drug.

I trimester of pregnancy.

Carefully:Exacerbation of allergic and autoimmune diseases.

Pregnancy and lactation:

Clinical studies have proved the efficacy and safety of the use of the drug Genferon® Light in women who are 13-40 weeks pregnant. Application in the first trimester of pregnancy is contraindicated.

Has no restrictions to use during lactation.

Dosing and Administration:

The drug can be used both vaginally and rectally. The method of administration, the dose and duration of the course depend on the age and the specific clinical situation.

In adults and children over the age of 7, Genferon® Light is used in a dose of 250 000 IU of interferon alfa-2b to the suppository. In children under 7 years, including infants, it is safe to use the drug at a dose of 125,000 ME interferon alfa-2b to the suppository. For women who are 13-40 weeks pregnant, the drug is used at a dose of 250 000 ME interferon alfa-2b to the suppository.

Recommended doses and treatment regimens:

1 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 5 days of treatment 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.

2 Chronic infectious-inflammatory diseases of viral etiology in children older than 7 years: 1 suppository (250 000 ME) 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.

3 Acute infectious-inflammatory diseases of urogenital tract in children: by 1 suppository rectally 2 times a day with a 12-hour interval for 10 days against the background of a specific therapy prescribed and controlled by the doctor.

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

5 Infectious and inflammatory diseases of the urogenital tract in women: by 1 suppository (250,000 ME) 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 a specific therapy prescribed and controlled by the doctor. With prolonged forms 3 times a week every other day, 1 suppository for 1 -3 months.

Side effects:

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

To date, no serious or life-threatening side effects have been observed.

Overdose:

Cases of overdose of Genferon® Light are not registered. If you accidentally inject a larger number of suppositories than prescribed by your doctor, you should stop the further administration for 24 hours, after which the treatment can be resumed according to the prescribed schedule.

Interaction:

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

Special instructions:Without a prescription - suppositories vaginal and rectal 125 000 ME + 5 mg.

According to the prescription of the doctor, suppositories are vaginal and rectal 250 000 ME + 5 mg.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

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

Packaging:

For 5 suppositories in a planar cell box made of aluminum foil or PVC film.1 or 2 contour squares, together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005614/09

Date of registration:13.07.2009

The owner of the registration certificate:BIOCAD, CJSC BIOCAD, CJSC Russia

Manufacturer: & nbsp

BIOCAD, CJSC Russia

Information update date: & nbsp27.11.2015

Illustrated instructions

Instructions

Genferon® Light (Genferon Lite)