Genferon suppositories 55 mg + 1 IU + 10 mg 10 pcs.

Active substances: 

human recombinant interferon alpha-2b (rhIFN-α-2b); taurine 0.01 g; benzocaine 0.055 g;

Excipients: 

solid fat - qs to obtain a suppository weighing 1.65 g; dextran 60,000 - 0.0015 g; macrogol 1500 - 0.124 g; polysorbate 80 - 0.033 g; emulsifier T2 - 0.132 g; sodium hydrocytrate - 0.0001 g; citric acid - 0.0015 g; purified water - 0.066 g

Pharmacological group: immunomodulating agents, interferons.

ATX Code - L03AB05

PHARMACOLOGICAL PROPERTIES

Immunobiological properties

GENERON ^®  is a combined preparation whose action is due to the components that make up its composition. It has local and systemic effects.

The composition of the drug Genferon ^®  includes recombinant human interferon 
alpha-2b, produced by a strain of the bacterium Escherichia coli, into which the human interferon alpha-2b gene has been introduced by genetic engineering.

Interferon alfa-2b has an antiviral, immunomodulatory, antiproliferative and antibacterial effect. The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit virus replication. The immunomodulatory effect is manifested, first of all, by strengthening the cell-mediated reactions of the immune system, which increases the effectiveness of the immune response against viruses, intracellular parasites and cells that underwent tumor transformation. 

This is achieved through the activation of CD8 + T-killers, NK cells (natural killers), increased differentiation of B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as increased expression of molecules of the main histocompatibility complex of type I, which increases the likelihood recognition of infected cells by cells of the immune system. 

Activation of leukocytes 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 reactions of the immune system enhanced by the influence of interferon.

Taurine contributes to the normalization of metabolic processes and tissue regeneration, has a membrane-stabilizing and immunomodulating 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 (anestezin) is a local anesthetic. It reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, and blocks the conduction of nerve impulses. Prevents the occurrence of pain impulses in the endings of sensory nerves and their passage through nerve fibers. 

It has an exclusively local effect, not absorbed into the systemic circulation.

Pharmacokinetics

With rectal administration of the drug, a high bioavailability (over 80%) of interferon is noted, in connection with which 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 maximum concentration of interferon in blood serum is reached 5 hours after administration of the drug. The main route of excretion of α-interferon is renal catabolism. The half-life is 12 hours, which makes it necessary to use the drug 2 times 
a day.

As a 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, bervitis ulceritis, cervicitis, cervicitis , urethritis, balanitis, balanoposthitis.

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

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

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

The use of normalizing indices of local immunity during pregnancy periods of 13-40 weeks has been shown as part of the complex treatment 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 the drug Genferon ^® 250 000 IU in pregnancy 13-40 weeks. The safety of the drug in the first trimester of pregnancy has not been studied.

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

Carefully

Exacerbation of allergic and autoimmune diseases.

The drug is well tolerated by patients.

Very rare adverse reactions (<1/10000):

General disorders and disorders at the injection site

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

Phenomena may occur that occur with all types of interferon alfa-2b, such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, and leukemia and thrombocytopenia, but they are more common when exceeded daily doses in excess of
10,000,000 IU. To date, no serious adverse events have been observed.

As with any other preparation of interferon alfa-2b, in case of temperature increase after its administration, a single dose of paracetamol in a dose of
500-1000 mg is possible .

GENERON ^{® is} most effective in combination with medicines (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.

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

1 suppository (250,000 ME or 500,000 ME 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 protracted 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 indices of local immunity in the treatment of infectious and inflammatory diseases of the urogenital tract in women with a gestational age of 13–40 weeks, 1 suppository of 250,000 IU is used vaginally 2 times a day every day for 10 days.

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

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

3. As part of the complex treatment 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 in order to prevent relapse .

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) through day for 10 days.

No cases of overdose with GENFERON ^® have been reported. In case of accidental simultaneous administration of a larger number of suppositories than was prescribed by a doctor, further administration should be suspended for 24 hours, after which treatment can be resumed according to the prescribed scheme. 

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

The use of the drug during menstruation is allowed.

The GENERON ^® preparation does not affect the execution of potentially hazardous activities requiring special attention and quick reactions (driving vehicles, machinery, etc.).