Expiration date: 06/2026

The composition and form of issue:

Suppositories for vaginal or rectal use 1 supp. contains active substances: 

interferon Alfa-2b 500000 IU

taurine 0.01 g

benzocaine 0,055 g

excipients: dextran 60000 1500 macrogol Polysorbate 80 emulsifier T2 hydrocitrate sodium citric acid purified water the solid fat 

in a cells contour package 5 supp. in the paper cartons 1 or 2 packs.

Suppositories for vaginal or rectal use 1 supp. contains active substances: 

interferon Alfa-2b 1000000 IU

taurine 0.01 g

benzocaine 0,055 g

excipients: dextran 60000 1500 macrogol Polysorbate 80 emulsifier T2 hydrocitrate sodium citric acid purified water the solid fat 

in a cells contour package 5 supp. in the paper cartons 1 or 2 packs.

Description pharmaceutical form:

Suppositories white or white with a yellowish sheen color, cylindrical shape, pointed end, on the longitudinal section is uniform. The cut allowed the presence of air core or funnel-shaped depressions.

Pharmacological action:

Immunomodulatory, antiviral, antibacterial, anti-proliferative, regenerative, local anesthetic.

Immunobiological properties

Genferon ® is a combination drug whose action caused by components that are part of it. Having local and systemic action.

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

Interferon Alfa-2b has antiviral, immunomodulatory, antiproliferative and antibacterial effect. The antiviral effect mediated by activation of several intracellular enzymes, inhibiting the replication of viruses. Immunomodulatory effect is manifested primarily by enhancing cell-mediated immune system, which increases the efficiency of the immune response against viruses, intracellular parasites and cells undergone tumor transformation. This is achieved through the activation of CD8+ T-killer cells, NK-cells (natural killer cells), enhanced the differentiation of b-lymphocytes and the production of the antibodies, the activation of the monocyte-macrophage system and phagocytosis, and enhance the expression of molecules of major histocompatibility complex type I, which increases the probability of detecting infected cells and immune cells. Activation under the influence of interferon leukocytes contained in all layers of the mucous membrane, ensures their active participation in the elimination of pathological lesions in addition, due to the influence of interferon is achieved the restoration of production of secretory immunoglobulin A. the Antibacterial effect is mediated by reactions of the immune system, strengthen under the influence of interferon.

Taurine promotes the normalization of metabolic processes and tissue regeneration, has a membrane stabilizing, and immunomodulatory effects. A powerful antioxidant, taurine directly interacts with active forms of oxygen, the accumulation of which contributes to the development of pathological processes. Taurine promotes the preservation of biological activity of interferon, increasing the therapeutic effect of the drug.

Benzocaine (benzocaine) is a local anesthetic. Reduces the permeability of cell membrane to sodium ions displaces calcium ions from receptors located on the inner surface of the membrane, blocks the conduction of nerve impulses. Prevents pain impulses in sensory nerve endings and their conduction along the nerve fibers. Has only a local effect not penetrate into the systemic circulation.

Pharmacokinetics:

For rectal administration of the drug there is a high bioavailability (80%) of interferon in this connection is achieved both local and pronounced systemic immunomodulatory effect in intravaginal application, due to the high concentration at the source of the infection and fixation of the mucosa cells is achieved a pronounced local antiviral, antiproliferative and antibacterial effect, while systemic effects due to the low suction capacity of the vaginal mucosa is negligible. Cmax of interferon in the blood serum is achieved after 5 h after drug administration. The main route of elimination is renal catabolism. T1/2 is 12 h, which necessitates the use of the drug 2 times a day.

Indications:

In combination of complex therapy of infectious-inflammatory diseases of the urogenital tract in adults:

• genital herpes
  
• chlamydia
  
• ureaplasmosis
  
• mycoplasmosis
  
• recurrent vaginal candidiasis
  
• gardnerellosis
  
• trichomoniasis
  
• human papillomavirus infection
  
• bacterial vaginosis
  
• cervical erosion
  
• cervicitis
  
• vulvovaginitis
  
• bartholinitis
  
• adnexitis
  
• prostatitis
  
• urethritis
  
• balanitis
  
• balanoposthitis.
  

Contraindications:

Individual intolerance of the interferon and other substances in the preparation.

Caution: aggravation of allergic and autoimmune diseases.

Application of pregnancy and breast-feeding:

Shows the use of normalization of local immunity in pregnancy 13-40 weeks in the complex therapy of genital herpes, chlamydia, ureaplasmosis, mycoplasmosis, cytomegalovirus infection, human papillomavirus infection, bacterial vaginosis in the presence of itching, discomfort and pain in the region of lower parts of urogenital tract.

Side effects:

The drug is well tolerated. Possible local allergic reactions (burning sensation in the vagina). These phenomena are reversible and disappear within 72 h after cessation of infusion. Continued treatment is possible after consultation with the doctor. Phenomenon can be observed arising from the application of all types of interferon alpha-2b such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, and leuko - and thrombocytopenia, but more often they occur when exceeding the daily dose of more than 10000000 IU. Hitherto not experienced severe side effects.

As with any other drug interferon Alfa-2b, in the case of temperature increase after the introduction of possible single dose of paracetamol at a dose of 500-1000 mg.

Drug interactions:

Genferon ® is most effective when combined with drugs (including antibiotics and other antimicrobial drugs) used to treat urogenital diseases. Non-narcotic analgesics enhance the effect of benzocaine. Benzocaine reduces the antibacterial activity of sulfonamides.

Method of application and dose:

Vaginally, rectally.

Infectious-inflammatory diseases of urogenital tract in women. 1 supp. (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 every day for 10 days. In protracted forms 3 times a week using day 1 supp. within 1-3 months.

In severe infectious-inflammatory process in the vagina and possibly the use of 1 candle (500000 IU) intravaginally in the morning and 1 candle (1000000 IU) rectally at night simultaneously with the introduction into the vagina of a candle that contains an antibacterial/antifungal agents.

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

Overdose:

The cases of drug overdose Genferon ® were reported. In case of accidental simultaneous introduction of more suppositories than prescribed by your doctor should suspend the further introduction of 24 h, after which the treatment can be renewed according to a prescribed scheme.

Special instructions:

To prevent reinfection urogenital encouraged to consider the simultaneous treatment of sexual partners.

Allowed the use of the drug during menstruation.

The drug Genferon ® does not affect the performance of potentially hazardous activities that require special attention and fast reactions (driving, machinery, etc.).