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Light Genferon® 250,000 IU 10s suppositories

$19.00

3eb768a05b7c

Description

The instruction for medical use of LIGHT GENFERON® medicine Trade name ГЕНФЕРОН® the LIGHT International unlicensed name Is not present the Dosage form Suppositories of 125,000 ME, 250,000 ME for vaginal or rectal administration Structure One suppository contains active agents: interferon alpha 2b human recombinant (рчИФН-α2b) 125,000 ME 250,000 ME, taurine of 0.005 g 0.005 g, excipients: a dextran 60,000, a macrogoal 1500, polysorbate 80, T2 emulsifier, sodium hydrocitrate, the citric acid, water purified, solid fat. The description Suppositories of color of a cylindrical form, white or white with a yellowish shade, with the pointed end, on longitudinal section are uniform. On a cut the existence of an air core or funneled deepening is allowed. Pharmacotherapeutic group Antineoplastic drugs and immunomodulators. Immunomodulators. 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 the local, and significant 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 effect, at the same time systemic action, due to the low soaking-up ability of a mucous membrane of a vagina, insignificant is 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 makes 12 hours that causes need of use of drug 2 times a day. Pharmacodynamics ГЕНФЕРОН® LIGHT – 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® LIGHT. 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 all layers of a mucous membrane provides their active participation in elimination of the pathological centers, besides, due to influence of interferon the restoration of products of secretory immunoglobulin A is reached. 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 strong 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. Indications – as a component of complex therapy – for treatment of acute respiratory viral infections and other infectious diseases of a bacterial and virus etiology at children – as a component of complex therapy – for treatment and prevention of repeated episodes of acute respiratory viral infections at it is frequent and long the ill children aged from 3 up to 6 years – for treatment of infectious and inflammatory diseases of an urogenital path at children and women, including pregnant women, against the background of appointed and the controlled doctor of specific therapy the Route of administration and doses Drug can be used at adults both vaginalno, and rektalno: at children – only rektalno! The method of administration, a dosage and duration of a course depend on age, a specific clinical situation and are defined by the attending physician. At adults and children 7 years ГЕНФЕРОН® are more senior LIGHT apply in a dosage of 250,000 ME. At children since the birth and to 7 years the use of drug in a dosage of 125,000 ME of interferon alpha 2b on a suppository is safe. At the women who are on 13-40 week of pregnancy, drug is used in a dosage of 250,000 ME of interferon alpha 2b on a suppository. The recommended doses and the modes of treatment: Acute infectious and inflammatory diseases of an urogenital path at children: on 1 suppository rektalno 2 times a day with a 12-hour interval within 10 days against the background of appointed and the controlled doctor of specific therapy. Infectious and inflammatory diseases of an urogenital path at pregnant women: on 1 suppository (250,000 ME) vaginalno 2 times a day with a 12-hour interval within 10 days against the background of appointed and the controlled doctor of specific therapy. Infectious and inflammatory diseases of an urogenital path at women: on 1 suppository (250,000 ME) vaginalno or rektalno (depending on the nature of a disease) 2 times a day with a 12-hour interval within 10 days against the background of appointed and the controlled doctor of specific therapy. At long forms 3 times a week every other day on 1 suppository within 1-3 months. Acute respiratory viral infections and other acute diseases of the virus nature at children: on 1 suppository rektalno 2 times a day with a 12-hour interval parallel to the main therapy within 5 days. If after the 5-day term of treatment the symptoms of a disease do not decrease or become more expressed, the patient should see a doctor. According to clinical indications the repetition of a course of treatment after a 5-day interval is possible. Acute respiratory viral infections at it is frequent and long the ill children aged from 3 up to 6 years: on 1 suppository (125,000 ME) rektalno 2 times a day at an interval of 12 hours within 10 days parallel to standard therapy. After end of the main period of treatment of an acute respiratory viral infection the transition to the preventive scheme is possible: on 1 suppository (125,000 ME) rektalno 1 time for the night every other day within 3 weeks. Chronic infectious and inflammatory diseases of a virus etiology at children: on 1 suppository (250,000 ME) rektalno 2 times a day with a 12-hour interval parallel to standard therapy within 10 days. Then within 1-3 months – on 1 suppository rektalno for the night every other day. Side effects Drug is well transferred by patients. Very seldom (frequency less than 1 on 10000 cases) – allergic reactions (single messages). These phenomena are reversible and disappear within 72 hours after the introduction termination. Continuation of treatment is possible after consultation with the doctor. So far heavy or life-threatening by-effects were not observed. Contraindications – individual intolerance of interferon and other substances which are a part of drug Medicinal interactions ГЕНФЕРОН® LIGHT it is most effective as a component of complex therapy. At a combination to antibacterial, fungicide and antiviral drugs the mutual potentiation of action is observed that allows to achieve high cooperative therapeutic effect. Special instructions With care to apply at exacerbation of allergic and autoimmune diseases. Pregnancy and the period of a lactation Clinical trials is proved efficiency and safety of use of the drug GENFERON® LIGHT for the women who are on 13-40 week of pregnancy. Safety of drug in 1 trimester of pregnancy is not studied. Has no restrictions to use in the period of a lactation. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Drug GENFERON® LIGHT does not influence performance of potentially dangerous types of activity requiring special attention and speed of reactions. Overdose About overdose cases by the drug GENFERON® LIGHT 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 / aluminum) 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 an expiration date. Prescription status Without prescription (suppositories of 125,000 ME) According to the prescription (suppositories of 250,000 ME) the Producer/packer of JSC BIOCAD, the Russian Federation the Legal address: Russian Federation, 198515, St. Petersburg, Petrodvorets district, item Strelna, Svyazi St., 34A. Phone number: +7 (812) 380 49 33, fax: +7 (812) 380 49 34, biocad@biocad.ru. Location address: Russian Federation, 143422, Moscow region, Krasnogorsk district, village of Petrovo-Dalneye. The owner of the registration certificate of JSC BIOCAD, the Russian Federation the Name and the address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers the Representative of the JSC BIOCAD company Republic of Kazakhstan, 050050, Almaty, Ryskulov St., 62-11. Ph.: 8 (727) 397-31-51, e-mail address: biocad_QANC@biocad.ru, biocad@biocad.ru. The name and the address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine the Representative of the JSC BIOCAD company Republic of Kazakhstan, 050050, Almaty, Ryskulov St., 62-11. Ph.: 8 (727) 397-31-51, e-mail address: safety@biocad.ru, biocad@biocad.ru.
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