Genferon 1000000 IU supp rect/Vagin N10

Prescription drug

Manufacturer: Биокад ЗАО
Рецептурный препарат
генферон 1000000 ме супп рект/вагин n10
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Brief information

Производитель

Биокад ЗАО

Действующее вещество

Интерферон альфа-2b+Бензокаин+Таурин

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Vaginal or rectal suppositories1 sup.
active substance: 
interferon alpha-2b human recombinant (rfifn-α-2b)250000/500000/1000000 IU
taurine 0.01 g
benzocaine0.055 g
excipients: solid fat-q. s. to obtain a suppository weighing 1.65 g; dextran 60000-0.0015 g; macrogol 1500-0.124 g; Polysorbate 80-0.033 g; emulsifier T2-0.132 g; sodium hydrocitrate-0.0001 g; citric acid-0.0015 g; purified water-0.066 g 

Description of the dosage form

Suppositories are white or white with a yellowish tinge of color, cylindrical in shape, with a pointed end, on the longitudinal section are uniform. An air rod or funnel-shaped recess is allowed on the cut.

Pharmacokinetics

With rectal administration of the drug, there is a high bioavailability (more than 80%) of interferon, which is why both local and pronounced systemic immunomodulatory effects are achieved; with intravaginal use, due to the high concentration in the focus of infection and fixation on the cells of the mucous membrane, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect due to the low absorption capacity of the vaginal mucosa is insignificant. The C max of interferon in the blood serum is reached 5 hours after administration of the drug. The main route of excretion is through the kidneys. T 1/2 is 12 hours, which makes it necessary to use the drug 2 times a day.

Pharmacodynamics

Immunobiological properties

Genferon-a combined drug, the effect of which is due to the components that are part of it. It has a local and systemic effect.

The drug Genferon includes recombinant human interferon alpha-2b, produced by a strain of the bacterium Escherichia coli, in which the human interferon alpha-2b gene was introduced by genetic engineering methods.

Interferon alpha-2b has antiviral, immunomodulatory, antiproliferative and antibacterial effects. The antiviral effect is mediated by activation of a number of intracellular enzymes that inhibit viral replication. The immunomodulatory effect is manifested primarily by enhancing cell-mediated responses 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 killers), increasing the differentiation of B-lymphocytes and their production of antibodies, activating the monocyte-macrophage system and phagocytosis, and increasing the expression of molecules of the main histocompatibility complex type I, which increases the probability of recognizing infected cells by cells of the immune system. Activation under the influence of interferon of white blood cells 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 recovery of secretory IDA production is achieved. The antimicrobial effect is mediated by immune system responses that are enhanced by interferon.

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

Benzocaine (anesthesin) is a local anesthetic. It reduces the permeability of the cell membrane to sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, and blocks nerve impulses. Prevents the occurrence of pain impulses in the endings of sensitive nerves and their conduct along the nerve fibers. It has an exclusively local effect, without being absorbed into the systemic bloodstream.

Indications of the drug

As part of complex therapy in adults with the following diseases and conditions:

infectious and inflammatory diseases of the urogenital tract — genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, recurrent vaginal candidiasis, gardnerellosis, trichomoniasis, papillomavirus infection, bacterial vaginosis, cervical erosion, cervicitis, vulvovaginitis, bartolinitis, adnexitis, prostatitis, urethritis, balanitis, balanoposthitis;

acute bronchitis;

chronic recurrent cystitis of bacterial etiology.

Contraindications

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

Caution: exacerbation of allergic and autoimmune diseases.

Use during pregnancy and lactation

It is shown that the use of local immunity for normalization of indicators during pregnancy of 13-40 weeks as part of the complex therapy of genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, CMV, papillomavirus infection, bacterial vaginosis in the presence of itching, discomfort and pain in the lower parts of the urogenital tract.

Clinical studies have proven the safety of intravaginal use of the drug Genferon 250,000 IU at pregnancy periods of 13-40 weeks.

The safety of the drug in the first trimester of pregnancy has not been studied.

Dosage and administration

Vaginally, rectally.

Infectious and inflammatory diseases of the urogenital tract in women. 1 sup. (250000, 500000 or 1000000 IU, depending on the severity of the disease) vaginally or rectally (depending on the nature of the disease) 2 times a day daily for 10 days. With prolonged forms 3 times a week every other day, 1 supp. within 1-3 months.

If there is a pronounced infectious-inflammatory process in the vagina, it is possible to use 1 supp. (500000 IU) intravaginal in the morning and 1 supp. (1,000,000 IU) rectally at night simultaneously with the introduction of a suppository containing antibacterial/fungicidal agents into the vagina.

To normalize the indicators of local immunity in the treatment of infectious and inflammatory diseases of the urogenital tract in women with pregnancy of 13-40 weeks, 1 supp is used. 250,000 IU vaginally 2 times a day, daily for 10 days.

Infectious and inflammatory diseases of the urogenital tract in men. Rectally, 1 supp. (500,000 IU or 1,000,000 IU depending on the severity of the disease) 2 times a day for 10 days.

Acute bronchitis in adults (as part of complex therapy). 1 sup. (1,000,000 IU) rectally 2 times a day for 5 days.

Chronic recurrent cystitis in adults (as part of complex therapy). With exacerbation - 1 supp. (1,000,000 IU) rectally 2 times a day for 10 days in combination with a standard course of antibacterial therapy, then-1 supp. (1,000,000 IU) rectally every other day for 40 days to prevent relapses.

Side effect

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 that occur when using all types of interferon alpha-2b, such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, as well as leukocytopenia and thrombocytopenia, but they are more common when the daily dose is significantly exceeded over 10000000 IU. To date, no severe side effects have been observed.

As with any other interferon alpha-2b drug, if the temperature increases after its administration, a single dose of paracetamol at a dose of 500-1000 mg is possible.

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 enhance the effect of benzocaine.

Benzocaine reduces the antibacterial activity of sulfonamides.

Overdose

Cases of overdose of the drug Genferon have not been reported. In case of accidental simultaneous administration of more 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 scheme.

Special instruction

To prevent urogenital reinfection, it is recommended to consider simultaneous treatment of the sexual partner.

It is allowed to use the drug during menstruation.

Influence on the ability to drive vehicles and mechanisms. The drug Genferon does not affect the performance of potentially dangerous activities that require special attention and rapid reactions (driving vehicles, machinery, etc.).

Form release

Vaginal or rectal suppositories, 55 mg+250000 IU+10 mg, 55 mg+500000 IU+10 mg, 55 mg+1000000 IU+10 mg.5 supp. in contour cell packaging made of aluminum foil or PVC film. 1 or 2 contour cell packages are placed in a pack of cardboard.

Conditions of supply of pharmacies

By prescription.

Manufacturer

CJSC BIOCAD, 198515, Russia, St. Petersburg, Petrodvorets district, p. Strelna, Svyazi str., 34, Lit. But.

Produced by: CJSC BIOCAD, 143422, Russia, Moscow region, Krasnogorskiy R-n, s. Petrovo-dal'neye.

Tel.: (495) 992-66-28; Fax: (495) 992-82-98.

e-mail: biocad@biocad.ru

Complaints about the drug should be sent to the Federal state Institute for standardization and control of medical biological products. L. A. Tarasevich of the Ministry of health of Russia: 41, Sivtsev Vrazhek str., Moscow, 119002.

Tel.: (499) 241-39-22; Fax: (499) 241-92-38.

e-mail: GISK@online.ru and to the manufacturer.

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

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