Genferon® (Genferon)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspVaginal and rectal suppositories
Composition:

1 suppository for dosages

55 mg + 250 000 ME + 10 mg,

55 mg + 500 000 ME + 10 mg,

55 mg + 1 000 000 ME + 10 mg

accordingly contains:

active ingredients: interferon alfa-2b human recombinant (rchIFN-α2b - 250 000 ME, or 500 000 ME, or 1 000 000 ME; taurine - 0.01 g; benzocaine-0.055 g;

Excipients: solid fat - a sufficient amount to obtain a suppository with a mass of 1.65 g, dextran 60 000 - 0.0015 g, macrogol 1500 - 0.1240 g, polysorbate 80 - 0.0330 g, emulsifier T2 -0.1320 g, sodium hydrocitrate - 0.0001 g, citric acid - 0.0015 g, purified water - 0.0660 g.

Description:

Suppositories white or white with a yellowish hue, color, cylindrical shape with a pointed end, on the longitudinal section are 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®- Combined drug, the effect of which is due to the components that make up its composition. Has a local and systemic effect.

    The preparation of Genferon® contains 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.

    Benzocaine (anestezin) is a local anesthetic. Reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, blocks the conduct of nerve impulses. Prevents the appearance of painful impulses in the endings of the sensory nerves and their conduction along nerve fibers. Has an exclusively local effect, not absorbed into the systemic circulation.

    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; with intravaginal application due to high concentration in the focus of infection andfixation on the cells of the mucous membrane, 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 part of complex therapy for infectious and inflammatory diseases of the urogenital tract in adults: genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, recurrent vaginal candidiasis, gardnerellez, trichomoniasis, papillomavirus infection, bacterial vaginosis, cervical erosion, cervicitis, vulvovaginitis, bartholinitis, adnexitis, prostatitis , urethritis, balanitis, balanoposthitis;

    In the complex therapy of acute bronchitis in adults.

    Contraindications:

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

    Carefully:

    Exacerbation of allergic and autoimmune diseases.

    Pregnancy and lactation:

    The use of local immunity for normalization of the indices of local immunity at the gestation period of 13-40 weeks is shown in the complex therapy of genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, cytomegalovirus infection, papillomavirus infection, bacterial vaginosis with itching, discomfort and pain in the lower urogenital tract.

    Clinical studies have shown the safety of intravaginal application of the drug Genferon® 250,000 ME when pregnancy is 13-40 weeks. The safety of the drug in the first trimester of pregnancy has not been studied.

    Dosing and Administration:

    1. Infectious and inflammatory diseases of the urogenital tract in women.

    For 1 suppository (250 000 ME or 500 000 ME or 1 000 000 ME depending on the severity of the disease) vaginally or rectally (depending on the nature of the disease) 2 times daily for 10 days. With prolonged forms 3 times a week every other day, one suppository for 1-3 months. With a pronounced infectious-inflammatory process in the vagina, it is possible to use 1 suppository 500 000 ME intravaginally in the morning and 1 suppository 1 000 000 ME rectally at night, simultaneously with the introduction into the vagina of a suppository containing antibacterial / fungicidal agents.

    To normalize the indices of local immunity in the treatment of infectious inflammatory diseases of the urogenital tract in women with gestational periods of 13-40 weeks, 1 suppository 250 000 ME vaginally 2 once a day for 10 days.

    2. Infectious and inflammatory diseases of the urogenital tract in men.

    Rectal by 1 suppository (500,000 ME or 1 000 000 ME depending on the severity of the disease) 2 times a day for 10 days.

    3. In the complex therapy of acute bronchitis in adults.

    For 1 suppository (1 000 000 ME) rectally 2 times a day for 5 days.
    Side effects:

    The drug is well tolerated by patients. Possible local allergic reactions (burning sensation in the vagina). These phenomena are reversible and disappear within 72 hours after discontinuation of administration. Continuation of treatment is possible after consultation with a doctor.

    There may be phenomena occurring when all types of interferon alfa-2 are usedb, such as chills, fever, fatigue,loss of appetite, muscle and headaches, joint pain, sweating, as well as leuko- and thrombocytopenia, but more often they occur when the daily dose exceeds 10,000,000 ME. So far, no serious side effects have been observed.

    As for any other drug interferon alfa-2b, in the case of an increase in temperature after its introduction, a single dose of paracetamol in a dose of 500-1000 mg is possible.

    Overdose:

    In cases of overdose with the drug GENFERON® was not reported. 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® is most effective in combination with drugs, (including antibiotics and other antimicrobials) used to treat urogenital diseases. Non-narcotic analgesics and anticholinesterase drugs intensify the action of benzocaine. Benzocaine reduces the antibacterial activity of sulfonamides.

    Special instructions:

    To prevent urogenital reinfection, it is recommended to consider the simultaneous treatmentsexual partner.

    Allowed the use of the drug during menstruation.

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

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

    Form release / dosage:

    Suppositories 55 mg + 250,000 IU + 10 mg, 55 mg + 500,000 IU + 10 mg, 55 mg + 1000,000 IU + 10 mg.

    Packaging:

    For 5 suppositories in a planar cell box made of aluminum foil or PVC film.

    1 or 2 contour packs with instructions for use in a cardboard package.

    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 expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001812 / 01
    Date of registration:30.09.2009 / 13.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOCAD, CJSC BIOCAD, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.03.2017
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