Genferon vaginal/rectal suppositories, 55mg+500 kM+10mg 10pcs

Composition

Active ingredients:  

human recombinant Interferon alfa-2b (rfIFN-α-2b); taurine 0.01 g; benzocaine 0.055 g;

Auxiliary substances:  

solid fat — q. s. to obtain a suppository weight 1.65 g; dextran 60000 — 0.0015 g; macrogol 1500 — 0,124 g; Polysorbate 80 — 0,033 g; emulsifier T 2 — 0,132 g; hydrocitrate sodium — 0.0001 g; citric acid — 0.0015 g; purified water — 0,066 g

Pharmacological properties

pharmacotherapeutic group: immunomodulatory agent, interferon.

ATX code-L03AB 05

PHARMACOLOGICAL PROPERTIES

Immunobiological properties

GENFERON® is a combined drug, the action of which is due to the components that make up its composition. It has a local and systemic effect.

Genferon® contains recombinant human Interferon alfa-2b produced by a strain of the bacterium Escherichia coli, which has been genetically engineered to contain the human Interferon alfa-2b gene.

Interferon alfa-2b has antiviral, immunomodulatory, antiproliferative and antibacterial effects. The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit viral replication. The immunomodulatory effect is manifested primarily by an increase in 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+ killer T cells, NK cells (natural killers), and enhancing differentiation. B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as an increase in the expression of molecules of the main type I histocompatibility complex, which increases the probability of recognition of infected cells by immune system cells.

Activation of white blood cells contained in all layers of the mucous membrane under the influence of interferon 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 under the influence of interferon.

Taurine contributes to the normalization of metabolic processes and tissue regeneration, has a membrane-stabilizing and immunomodulatory effect. Being a strong antioxidant, taurine directly interacts with reactive oxygen species, 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 (anaesthesin) is a local anaesthetic. Reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from the receptors located on the inner surface of the membrane, blocks the conduction of nerve impulses. Prevents the occurrence of pain impulses in the endings of sensitive nerves and their conduction through nerve fibers.

It has an exclusively local effect, without being absorbed into the systemic circulation.

Pharmacokinetics

With rectal use of the drug, high bioavailability (more than 80%) of interferon is noted, and therefore 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 mucosal cells, a pronounced local antiviral, antiproliferative and antibacterial effect is achieved, while the systemic effect is insignificant due to the low absorption capacity of the vaginal mucosa. The maximum concentration of interferon in the blood serum is reached 5 hours after use of the drug. The main route of alpha-interferon elimination is renal catabolism. The half-life is 12 hours, which makes it necessary to use 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, gardnerellosis, trichomoniasis, papillomavirus infection, bacterial vaginosis, cervical erosion, cervicitis, vulvovaginitis, bartholinitis, adnexitis, prostatitis, urethritis, balanitis, balanoposthitis.

As part of the complex therapy of acute bronchitis in adults.

As part of the complex therapy of chronic recurrent bacterial cystitis in adults.

As part of the complex therapy of chronic endometritis in adults.

Use during pregnancy and lactation

It is shown to normalize the indicators of local immunity during pregnancy of 13-40 weeks as part of the complex therapy of genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, cytomegalovirus infection, 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 Genferon ® 250,000 IU during pregnancy of 13-40 weeks. The safety of using the drug in the first trimester of pregnancy has not been studied.

Contraindications

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

With caution:  exacerbation of allergic and autoimmune diseases.

Side effects

The drug is well tolerated by patients.

Very rare adverse reactions (:

General disorders and disorders at the injection site

Possible allergic reactions, including local ones. Continuation of treatment is possible after consultation with a doctor.

There may be symptoms that occur with all types of Interferon alfa-2b, such as chills, fever, fatigue, loss of appetite, muscle and headache, joint pain, sweating, as well as leuko – and thrombocytopenia, but they are more common when the daily dose exceeds 10,000,000 IU. So far, no serious adverse events have been observed.

As with any other Interferon alfa-2b drug, if the temperature rises after its use, 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 for the treatment of urogenital diseases.

Non-narcotic analgesics and anticholinesterase agents Drugs enhance the effect of benzocaine.

Benzocaine reduces the antibacterial activity of sulfonamides.

How to take, course of use and dosage

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

Take 1 suppository (250,000 IU or 500,000 IU or 1,000,000 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 suppository for 1-3 months.

With a pronounced infectious and inflammatory process in the vagina, it is possible to use 1 suppository 500 000 IU intravaginally in the morning and 1 suppository 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 a gestation period of 13-40 weeks,1 suppository 250,000 IU is used vaginally 2 times a day daily for 10 days.

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

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

3. As part of the complex therapy of acute bronchitis in adults.

1 suppository (1,000,000 IU) rectally 2 times a day for 5 days.

4. As part of the complex therapy of chronic recurrent cystitis in adults.

In case of exacerbation – 1 suppository (1,000,000 IU) rectally 2 times a day for 10 days in combination with a standard course of antibacterial therapy, then 1 suppository (1,000,000 IU) rectally every other day for 40 days to prevent relapses.

5. As part of the complex therapy of chronic endometritis in adults.

Rectally,1 suppository (1,000,000 IU) 2 times a day for 10 days, then 1 suppository (500,000 IU) rectally 2 times a day for 10 days, then rectally 1 suppository (1,000,000 IU) every other day for 10 days.

Overdose

Cases of overdose with GENFERON® have not been reported. If a larger number of suppositories are randomly administered at one time than was prescribed by the doctor, further use should be suspended for 24 hours, after which treatment can be resumed according to the prescribed scheme.

Special instructions

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

It is allowed to use the drug during menstruation.

GENFERON®does not affect the performance of potentially dangerous activities that require special attention and rapid reactions (driving vehicles, machinery, etc. ).

Form of production

Rectal suppositories

Storage conditions

At a temperature of 2-8 °C

Expiration date

2 years old

Active ingredient

Benzocaine, Interferon alfa-2b, Taurine

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Purpose

For adults as prescribed by a doctor, for pregnant women as prescribed by a doctor

Indications

Thrush, Prostatitis, Urinary Tract Infections, Herpes, Vaginitis