The instruction for medical use of GENFERON® medicine the Trade name of Genferon® the International unlicensed name Is not present the Dosage form Suppositories of 500,000 ME, 1,000,000 ME Structure One suppository contains active agents: interferon alpha 2b human recombinant (рчИФН-α2b) 500,000 ME, 1,000,000 ME, taurine of 0.010 g, benzocaine of 0.055 g, excipients: solid fat, a dextran 60000, a macrogoal 1500, polysorbate 80, emulsifier T 2, sodium hydrocitrate, the citric acid, water purified. The description Suppositories of color, white or white with a yellowish shade, a cylindrical form with the pointed end, on longitudinal section are uniform. On a cut the existence of an air core or funneled deepening Pharmacotherapeutic group Immunomodulators is allowed. Immunostimulators. The ATX L03A code the Pharmacological Pharmacokinetics At properties rectal administration of drug is noted high bioavailability (more than 80%) of interferon in this connection both local, and systemic immunomodulatory action is reached. At intravaginalny use due to high concentration in the center of an infection and fixing on cells of a mucous membrane the significant local antiviral, anti-proliferative and antibacterial effects, at the same time systemic action, due to the low soaking-up ability of a mucous membrane of a vagina, insignificant are reached. The maximum concentration of interferon in blood serum is reached in 5 hours after rectal or vaginal administration of drug. The main way of removal of α-interferon is renal catabolism. Elimination half-life (T1/2) makes 12 hours that causes need of use of drug 2 times a day. Pharmacodynamics 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 the immune system that increases efficiency of the 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 a 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 the probability of recognition of the infected cells cells of the immune system. Activization under the influence of interferon of the leukocytes which are contained in a mucous membrane provides their active participation in elimination of the pathological centers and provides restoration of products of secretory immunoglobulin A. The antibacterial effect is mediated by the reactions of the immune system strengthened under the influence of interferon. Taurine contributes to normalization of metabolic processes and angenesis, possesses membrane stabilizing and immunomodulatory action. Being antioxidant, taurine directly interacts with active forms of oxygen which excess accumulation contributes to the development of pathological processes. Taurine promotes maintaining biological activity of interferon, enhancing 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. 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. Indications as a part of complex therapy in infectious and inflammatory diseases of an urogenital path at adults: – genital herpes – clamidiosis – ureaplasmosis – mycoplasmosis – recurrent vaginal candidiasis – a bacterial vaginosis – a trichomoniasis – a human papillomavirus infection – a bacterial vaginosis – an erosion of a neck of the uterus – a cervicitis – a vulvovaginitis – a bartholinitis – an adnexitis – prostatitis – an urethritis. A route of administration and doses Infectious and inflammatory diseases of an urogenital path at women. On 1 suppository (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 significant infectious and inflammatory process in a vagina the 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. 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. Side effects – allergic reactions (burning sensation in a vagina). The phenomena arising at use of all types of interferon alpha 2b, such as fever, temperature increase, fatigue, loss of appetite, muscular and headaches, joint pains, perspiration and also leucio- and thrombocytopenia can be observed, but they meet when exceeding a daily dose over 10,000,000 ME more often. So far heavy by-effects were not observed. Contraindications – individual intolerance of interferon and other substances which are a part of drug. Medicinal interactions ГЕНФЕРОН® it is most effective in combination with the medicines (including antibiotics and other antimicrobial drugs) applied to treatment of urogenital diseases. Non-narcotic analgesics and antikholinesterazny medicines strengthen effect of benzocaine. Benzocaine reduces antibacterial activity of streptocides. The special instructions Efficiency and safety of use for children up to 18 years it is not established. With care to apply at exacerbation of allergic and autoimmune diseases. The phenomena of allergic reaction in the form of burning in a vagina are reversible and disappear within 72 hours after the introduction termination. Continuation of treatment is possible after consultation with the doctor. As well as for any other drug of interferon alpha 2b, in case of temperature increase after its introduction, single dose of paracetamol in a dose of 500 mg is possible. 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. Pregnancy 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 itching, discomfort and pain in lower parts of an urogenital path Is shown. Clinical trials proved safety of intravaginalny use of the drug Genferon in a dose of 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. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Drug GENFERON® does not influence performance of potentially dangerous types of activity requiring special attention and fast reactions (control of vehicles, the machine equipment, etc.). Overdose About overdose cases by the drug GENFERON® it was not reported. At accidental single 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 on the ordered scheme. A form of release and packing On 5 suppositories in blister strip packaging from aluminum foil (aluminum/aluminium) or films polyvinylchloride (PVC/PVC). On 2 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature from 2 to 8 °C. To store out of children’s reach. 2 years not to apply a period of storage after the expiration date specified on packing. Prescription status According to the prescription JSC BIOCAD Producer, the Russian Federation the Legal address: Russian Federation, 198515, St. Petersburg, Petrodvorets district, item Strelna, Svyazi St., 34A. Location address: Russian Federation, 143422, Moscow region, Krasnogorsk district, village of Petrovo-Dalneye, p.o. box 26, phone number: +7 (495) 992-66-28, fax: +7 (495) 992-82-98. The owner of the registration certificate of JSC BIOCAD, the Russian Federation the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Republic of Kazakhstan, 050050, Almaty, Makarenko St., 66-42. Phone number: 7 (727) 384-38-05, +7 (495) 992-66-28, fax: +7 (495) 992-82-98. E-mail: email@example.com, website: www.biocad.ru.