Генферон®

General characteristics. Structure:

Active components: 500 000 ME or 1 000 000 ME of interferon alpha 2b, 0,01 g of taurine, 0,055 g of benzocaine.

Auxiliary components: a dextran 60 000, a macrogoal 1500, polysorbate 80, T2 emulsifier, sodium hydrocitrate, the citric acid, water purified solid fat.

The immunomodulatory, antiviral, antibacterial, anti-proliferative, regenerating, mestnoanesteziruyushchy agent.

Pharmacological properties:

Pharmacodynamics. Immunobiological properties. Генферон® — the combined drug which effect is caused by the components which are its part. Has local and systemic effect.

Recombinant human interferon alpha 2b, Escherichia coli developed by a strain of a bacterium into which methods of genetic engineering entered a gene of interferon alpha 2b the person is a part of the drug Genferon®.

Interferon alpha 2b renders antiviral, immunomodulatory, anti-proliferative and antibacterial action. The antiviral effect is mediated by activation of a number of the desmoenzymes inhibiting replication of viruses. Immunomodulatory action is shown, first of all, by strengthening of cell-mediated reactions of immune system that increases efficiency of an immune response concerning viruses, the intracellular parasites and cells which underwent tumoral transformation. It is reached due to activation of CD8+ of T-killers, NK cells (natural killers), strengthening of a differentiation of V-lymphocytes and products of antibodies by them, activation of monocytic and macrophagic system and phagocytosis, and also increase in an expression of molecules of the main complex of histocompatability of the I type that increases probability of recognition of the infected cells cells of immune system. Activation under the influence of interferon of the leukocytes which are contained in all layers of a mucous membrane provides their active participation in elimination of the pathological centers; besides, due to influence of interferon recovery of products of secretory immunoglobulin A is reached. The antibacterial effect is mediated by the reactions of immune system strengthened under the influence of interferon.

Taurine contributes to normalization of metabolic processes and an angenesis, possesses membrane stabilizing and immunomodulatory action. Being strong antioxidant, taurine directly interacts with active forms of oxygen which excess accumulation promotes development of pathological processes. Taurine promotes preservation of biological activity of interferon, strengthening therapeutic effect of use of drug.

Benzocaine (anaesthesin) is local anesthetic. Reduces permeability of a cellular membrane for sodium ions, forces out calcium ions from the receptors located on an internal surface of a membrane blocks carrying out nervous impulses. Interferes with emergence of painful impulses in the terminations of sensory nerves and to their carrying out on nerve fibrils. Renders exclusively local effect, without being soaked up in a system blood stream.

Pharmacokinetics. At rectal administration of drug high bioavailability (more than 80%) of interferon in this connection both the local, and expressed systemic immunomodulatory action is reached is noted; at intravaginalny use due to high concentration in the center of an infection and fixing on cells of a mucous membrane the expressed local antiviral, anti-proliferative and antibacterial effect, at the same time systemic action due to the low soaking-up ability of a mucous membrane of a vagina insignificant is reached. Cmax of interferon in blood serum is reached in 5 h after administration of drug. The main way of removal is the renal catabolism. T1/2 makes 12 h that causes need of use of drug 2 times a day.

Indications to use:

As a part of complex therapy at infectious and inflammatory diseases of an urogenital path at adults: genital herpes, clamidiosis, ureaplasmosis, the mycoplasmosis recuring vaginal candidiasis, a bacterial vaginosis, a trichomoniasis, a human papillomavirus infection, a bacterial vaginosis, an erosion of a neck of uterus, a cervicitis, a vulvovaginitis, a bartholinitis, an adnexitis, prostatitis, an urethritis, a balanitis, a balanoposthitis; acute infectious and inflammatory diseases of a respiratory path at adults.

Route of administration and doses:

1. Infectious and inflammatory diseases of an urogenital path at women.  On 1 suppository (250 000 ME or 500 000 ME or 1 000 000 ME depending on disease severity) vaginalno or rektalno (depending on the nature of a disease) 2 times a day daily within 10 days. At long forms 3 times a week every other day on 1 suppository within 1-3 months. At the expressed infectious and inflammatory process in a vagina use of 1 suppository of 500 000 ME intravaginalno in the morning and 1 suppository of 1 000 000 ME rektalno for the night along with introduction to a vagina of the suppository containing antibacterial/fungicidal agents is possible. At treatment of infectious and inflammatory diseases of an urogenital path at women at durations of gestation of 13-40 weeks apply to normalization of indicators of local immunity on 1 suppository of 250 000 ME vaginalno 2 times a day daily within 10 days.

2. Infectious and inflammatory diseases of an urogenital path at men. Rektalno on 1 suppository (500 000 ME or 1 000 000 ME depending on disease severity) 2 times a day within 10 days.

3. As a part of complex therapy of an acute bronchitis at adults. On 1 suppository (1 000 000 ME) rektalno 2 times a day within 5 days.

4. As a part of complex therapy of chronic recurrent cystitis at adults. At an aggravation — on 1 suppository (1 000 000 ME) rektalno 2 times a day within 10 days in a combination to a standard course of antibacterial therapy, then on 1 suppository (1 000 000 ME) rektalno every other day within 40 days for the purpose of prevention of a recurrence.

Features of use:

For prevention of urogenital reinfection it is recommended to consider a question of simultaneous treatment of the sexual partner.

Use of drug is allowed during periods.

The drug GENFERON® does not influence performance of potentially dangerous types of activity requiring special attention and bystry reactions (control of vehicles, the machine equipment, etc.).

Use during pregnancy and a lactation. Use for normalization of indicators of local immunity at durations of gestation of 13-40 weeks as a part of complex therapy of genital herpes, clamidiosis, ureaplasmosis, mycoplasmosis, a Cytomegaloviral infection, a human papillomavirus infection, a bacterial vaginosis in the presence of an itch, discomfort and pain in lower parts of an urogenital path is shown. Clinical trials proved safety of intravaginalny use of the drug Генферон® 250 000 ME at durations of gestation of 13-40 weeks. Safety of use of drug in the I trimester of pregnancy is not studied.

Side effects:

Drug is well transferred by patients. Local allergic reactions are possible (a burning sensation in a vagina). These phenomena are reversible and disappear during 72 h after the introduction termination. Continuation of treatment is possible after consultation with the doctor.

The phenomena arising at use of all types of interferon alpha 2b such as fever, temperature increase, fatigue, appetite loss, muscular and headaches, joint pains, perspiration, and also leucio-and thrombocytopenia can be observed, but they meet at exceeding of a daily dose over 10 000 000 ME more often. So far heavy by-effects were not observed.

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

Interaction with other medicines:

Генферон® it is most effective in combination with medicines, (including antibiotics and other antimicrobic drugs), applied to treatment of urogenital diseases. Non-narcotic analgesics and antikholinesterazny medicines strengthen effect of benzocaine. Benzocaine reduces antibacterial activity of streptocides.

Contraindications:

Individual intolerance of interferon and other substances which are a part of drug.

With care. Exacerbation of allergic and autoimmune diseases.

Overdose:

About overdose cases by the drug GENFERON® it was not reported. At accidental one-time introduction of bigger number of suppositories, than it was offered the doctor, it is necessary to suspend further introduction for 24 hours then treatment can be resumed according to the ordered scheme.

Storage conditions:

To store at a temperature from 2 to 8 °C.  To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Suppositories of 55 mg of +500 000 ME+10 of mg, 55 mg of +1000 000 ME+10 of mg. On 5 suppositories in a blister strip packaging from aluminum foil or a film polyvinyl chloride. 1 or 2 blister strip packagings together with the application instruction in a pack from a cardboard.