Genferon light candles 125000me + 5mg №10

Description and instruction

registration number: lsr - 005614/09

international non-proprietary name: Interferon alfa-2b + Taurine and.

dosage form: vaginal and rectal suppositories.

Henferon® Light is available in two forms:

1. 1 suppository (125,000 IU + 5 mg) contains:

active substances: interferon alfa-2b - 125,000 IU; Taurine - 0.005 g;

excipients: “solid fat”, dextran 60,000, macrogol 1500, polysorbate 80, emulsifier t2, sodium hydrocitrate, citric acid, purified water - sufficient amount to obtain a suppository weighing 0.8 g.

2. 1 suppository (250,000 IU + 5 mg) contains:

active substances: interferon alfa-2b - 250,000 IU; Taurine - 0.005 g;

excipients: “solid fat”, dextran 60,000, macrogol 1500, polysorbate 80, emulsifier t2, sodium hydrocitrate, citric acid, purified water - sufficient amount to obtain a suppository weighing 0.8 g.

Description: Cylindrical suppositories with a pointed end, white or white with a yellowish tinge, with a pointed end, are homogeneous on a longitudinal section. the cut is allowed to have an air rod or funnel-shaped recess.

pharmacological group: immunomodulating agents, interferons.

ATX code: l03a05

Pharmacology

immunobiological properties

Henferon® Light is a combined preparation, the effect of which is due to the components that make up it. has a local and systemic effect.

recombinant human interferon alpha-2b, produced by the strain of the bacterium escherichia coli, into which the human interferon alpha-2b gene is introduced by genetic engineering methods, is part of the preparation Genferon® Light.

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. The immunomodulatory effect is manifested primarily by the enhancement of 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 by activating
cd8 + t-killers, nk-cells (natural killer cells), enhancing differentiation
B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as increased expression of type I major histocompatibility molecules, which increases the likelihood of infected cells being recognized by cells of the immune system. activation of the 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 immune system reactions that are amplified by interferon.

Taurine contributes to the normalization of metabolic processes and tissue regeneration, has a membrane stabilizing and immunomodulatory effects. Being a strong antioxidant, taurine directly interacts with active forms of oxygen, the excessive accumulation of which contributes to the development of pathological processes. Taurine contributes to the preservation of the biological activity of interferon, enhancing the therapeutic effect of the drug.

with rectal administration of the drug, there is a high bioavailability (more than 80%) of interferon, in connection with which both local and pronounced systemic immunomodulating action is achieved; with intravaginal use, due to the high concentration in the focus of infection and fixation on the mucosal cells, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic action due to the low suction capacity of the vaginal mucosa is insignificant. The maximum concentration of interferon in the serum is reached 5 hours after drug administration. the main route of elimination of α-interferon is renal catabolism. the half-life is 12 hours, which necessitates the use of the drug 2 times a day.

Indications and usage

• for the treatment of infectious and inflammatory diseases of the urogenital tract in children and women, including pregnant women.

• as a component of complex therapy - for the treatment of other infectious diseases of viral etiology.

apply as prescribed by a doctor.

Dosage and administration

The drug can be used both vaginally and rectally. the method of administration, dosage and duration of the course depend on the age, specific clinical situation and are determined by the attending physician. in adults and children over 7 years old, Henferon® light is used at a dosage of 250,000 IU of interferon alfa-2b per suppository. in children under 7 years of age, it is safe to use the drug at a dosage of 125,000 IU of interferon alfa-2b per suppository.

Recommended doses and treatment regimens:

• acute infectious and inflammatory diseases of the urogenital tract in children: 1 suppository rectally 2 times a day with a 12-hour interval
  within 10 days.

• infectious and inflammatory diseases of the urogenital tract in pregnant women: 1 vaginal suppository, 2 times a day with a 12-hour interval for 10 days.

• infectious and inflammatory diseases of the urogenital tract in women. on 1 suppository (250 000 IU) vaginally or rectally
  (depending on the nature of the disease) 2 times a day with a 12-hour interval
  within 10 days. with prolonged forms 3 times a week every other day
  1 suppository for 1-3 months.

• acute infectious and inflammatory diseases of viral etiology in children: 1 suppository rectally 2 times a day with a 12-hour interval in parallel with the standard therapy for 5 days.if symptoms persist, the treatment is repeated after a 5-day interval.

• chronic infectious and inflammatory diseases of viral etiology in children: 1 suppository rectally 2 times a day with a 12-hour interval in parallel with the standard therapy for 10 days. then within 1-3 months - 1 suppository rectally for a night every other day.

side effect

the drug is well tolerated. possible local allergic reactions (sensation of itching and burning in the vagina). these phenomena are reversible and disappear within 72 hours after cessation of administration. continuation of treatment is possible after consulting a doctor.

to date, no serious or life-threatening side effects have been observed. phenomena occurring with the use of all types of interferon alfa-2b, such as chills, fever, fatigue, loss of appetite, muscle and headaches, pain in joints, sweating, and leuko- and thrombocytopenia, but more often they occur when exceeding daily dose in excess of 10 000 000 IU. in these cases, it is recommended to consult the attending physician to decide whether to discontinue the drug or reduce the dose.

as with any other drug interferon alpha, in the case of a temperature increase after its introduction, a single dose of Paracetamol is possible in a dose
500 - 1000 mg for adults and 250 mg for children.

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

carefully

exacerbation of allergic and autoimmune diseases.

use during pregnancy and lactation

Clinical studies have proven the efficacy and safety of using Genferon® Light in the second and third trimesters of pregnancy. safety of the drug in the i trimester of pregnancy has not been studied.

Henferon® 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.

Generon® light overdose cases have not been reported. in case of the occasional one-time introduction of a greater number of suppositories than was prescribed by the doctor, further administration should be suspended for 24 hours, after which treatment can be resumed according to the prescribed regimen.

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

storage and transportation conditions

at a temperature of 2 to 8 0s.

Keep out of the reach of children.

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

5 suppositories in a blister strip made of aluminum foil or polyvinyl chloride film.1 or 2 blister packs together with instructions for use in a pack of cardboard.

2 years.

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

by prescription.