Instruction for use: Genferon

Dosage form: Vaginal / rectal suppositories

Active substance: Interferonum alpha-2b + Taurinum + Benzocainum

ATX

L03AB05 Interferon alfa-2b

Pharmacological groups

Immunomodulating agents, interferons [Interferons in combinations]

Immunomodulating agents, interferons [Antiviral (excluding HIV) agents in combination]

The nosological classification (ICD-10)

A49.3 Mycoplasma infection, unspecified: Mycoplasma infection; Urogenital mycoplasmosis; Pulmonary infection caused by mycoplasma; Mycoplasma infections; Mycoplasmosis; Genitourinary infection caused by mycoplasma; Mycoplasma meningoencephalitis

A56 Other chlamydial diseases, sexually transmitted infections: Chlamydial infections; Chlamydia; Tropical bubo

A59 Trichomoniasis: Trichomonas infection; Trichomoniasis; Recurrent trichomoniasis in women; Chronic trichomoniasis; Acute trichomoniasis; Chronic complicated multifocal trichomoniasis

A60 Anogenital herpetic viral infection [herpes simplex]: Herpes simplex genitalis; Banal recurrent genital herpes; Secondary genital herpes; Genital herpesvirus infection; Genital herpetic infections; Genital herpes; Herpes genitalia; Genital herpes; Herpes simplex organs; Herpetic lesions of the mucocutaneous urinary organs; Herpetic lesions of the genitals; Primary genital herpes; Primary herpes simplex; Simple herpes extragenital and genital localization; Recurrent genital herpes; Recurrent herpes of genital organs; Herpes of the lips and genitals

A63.8 Other specified diseases, mainly sexually transmitted: Ureaplasmosis infection; Ureaplasmic infection; Ureaplasmosis

B37.3 Candidiasis of the vulva and vagina (N77.1 *): Vaginal candidiasis; Vaginal candidiasis; Vulval candidiasis; Vulvovaginal candidiasis; Vulvovaginal candidiasis; Vulvovaginitis candidiasis; Mycotic vulvovaginitis; Fungal vaginitis; Candidiasis of the vagina; Candidiasis of internal organs; Candidiasis of the urogenital; Candidiasis of the urogenital organs in women; Candidiasis with lesions of the skin and mucous membranes; Candidiasis of the mucous membranes; Candidiasis of mucous membranes and skin; Candidiasis of the vaginitis; Candidiasis vulvitis; Candidiasis vulvovaginitis; Colpitis of fungal etiology; Vaginal yeast infection; Moniliasis vulvovaginitis; Acute vaginal candidiasis; Acute mycosis of the vagina; Superficial candidiasis of the genital mucosa; Recurrent vaginal candidiasis; Recurrent vaginal candidiasis; Urogenital Candidiasis; Chronic vaginal candidiasis; Chronic candidiasis of mucous membranes; Chronic recurrent vaginal candidiasis

B97.7 Papillomavirus: Human papillomavirus; Asymptomatic selection of human papillomavirus; Papillomavirus infection; The papilloma virus; Upper respiratory tract papillomatosis; Papillomovirus infection; Human papillomaviruses

J20 Acute bronchitis: Acute bronchitis; Acute bronchial disease; Disease of the bronchi; Viral bronchitis; Infectious bronchitis

N30.1 Interstitial cystitis (chronic): Exacerbation of chronic cystitis; Chronic cystitis; Recurrent cystitis; Acute attack of recurrent bacterial cystitis; Chronic interstitial cystitis

N30.2 Other chronic cystitis: Acute attack of recurrent bacterial cystitis; Recurrent cystitis; Chronic cystitis; Exacerbation of chronic cystitis

N34 Urethritis and urethral syndrome: Urethral buzhirovanie; Gonococcal urethritis; Urethrocystitis; Gonorrheic urethritis; Urethritis; Non-gonococcal urethritis; Negative urethritis; Lesion of the urethra; Acute gonococcal urethritis; Acute gonorrhea urethritis; Acute urethritis; Infection of the urethra; Bacterial nonspecific urethritis; Bacterial urethritis

N41 Inflammatory diseases of the prostate: Prostatitis; Disease of the prostate; Infection of the genitals; Chronic non-specific prostatitis

N48.1 Balanoposthitis: Non-specific balanoposthitis

N48.6 Balanitis: Balanitis dry obliterating; Fungal balanitis

N70 Salpingitis and oophoritis: Adnexitis; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Infection of the genitals; Oophoritis; Acute adnexitis; Salpingitis; Salpingo-oophoritis; Chronic inflammatory diseases of the ovaries; Inflammation of the ovaries

N72 Inflammatory diseases of the cervix: Muco-purulent cervicitis; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Gonococcal cervicitis; Gonorrheal cervicitis; Infection of the genitals; Non-gonorrhal cervicitis; Uncomplicated cervicitis; Nonspecific cervicovaginitis; Acute gonorrhea cervicitis; Cervicovaginitis; Cervicitis; Exocervicitis; Endocervicitis; Bacterial colpitis; Bacterial capsules

N74.4 Female pelvic inflammatory disease caused by chlamydia (A56.1 +): Chlamydial salpingitis; Chlamydial infections; Chlamydia

N75.9 Bartholin gland disease, unspecified: Bartholinitis

N76 Other inflammatory diseases of the vagina and vulva: Vulvovaginitis atrophic; Vulvovaginitis bacterial; Vulvovaginitis estrogen-deficient; Bacterial vaginosis; Vaginitis; Vaginitis bacterial; Inflammatory diseases of the vagina and vulva; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Vulvit; Vulvovaginitis; Vulvovaginitis; Gardnerella; Fungal vulvovaginitis in girls and virgins; Infection of the vagina; Infection of the genitals; Colpitis; Violation of purity of the vaginal secretion; Nonspecific cervicovaginitis; Nonspecific vulvitis; Nonspecific vulvovaginitis; Nonspecific colpitis; Recurrent nonspecific bacterial vaginosis; Senylic coverings; Mixed Colpus; Chronic vaginitis; Vulvovaginal infections; Bacterial vaginitis; Bacterial vaginosis; Bacterial vaginitis; Mixed vaginal infections

N86 Erosion and ectropion of the cervix: Ectopia of the cervix uteri; Ectropion of cervix uter; Vaginal erosion; Cervical erosion; Ulcers on the cervix; Cervical ectopia

Composition

Suppositories vaginal or rectal 1 supp.

Active substances: Interferon alpha-2b human recombinant (rchIFN-α-2b) 250000/500000/1000000 IU

Taurine 0.01 g

Benzocaine 0.055 g

Excipients: solid fat - q.s. To obtain a suppository with a mass of 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 dosage form

Suppositories white or white with a yellowish hue of color, cylindrical, with a pointed end, on the longitudinal section are uniform. On the cut, an air rod or a funnel-shaped depression is allowed.

Pharmachologic effect

Mode of action - antiviral, immunomodulating, antioxidant, locally anesthetic.

Pharmacodynamics

Immunobiological properties

Genferon ® - a combined drug, the effect of which is due to the components that make up its composition. Has a local and systemic effect.

The preparation of Genferon® contains recombinant human interferon alpha-2b, produced by the strain of the bacterium Escherichia coli, into which the human interferon alpha-2b gene has been introduced into the gene.

Interferon alfa-2b has antiviral, immunomodulating, antiproliferative and antibacterial action. The antiviral effect is mediated by the activation of a number of intracellular enzymes that inhibit the replication of viruses. Immunomodulatory effect is manifested primarily by the intensification of cell-mediated immune system reactions, which increases the effectiveness of the immune response against viruses, intracellular parasites and cells that underwent tumor transformation. This is achieved by activation of CD8 + T-killers, NK cells (natural killers), enhancement of B-lymphocyte differentiation and production of antibodies, activation of monocyte-macrophage system and phagocytosis, as well as increased expression of molecules of the main histocompatibility complex of type I, which increases the probability Recognition of infected cells by cells of the immune system. Activation under the influence of interferon leukocytes 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 achieved restoration of secretory IgA production. The antibacterial effect is mediated by immune system reactions, enhanced by 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 active forms of oxygen, the excessive accumulation of which contributes to the development of pathological processes. Taurine promotes the preservation of the biological activity of interferon, enhancing the therapeutic effect of the drug.

Benzocaine (anesthesin) is a local anesthetic. Reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, blocks the conduct of nerve impulses. Prevents the appearance of painful impulses in the endings of the sensory nerves and their conduction along nerve fibers. Has an exclusively local effect, not absorbed into the systemic circulation.

Pharmacokinetics

When rectal administration of the drug, high bioavailability (more than 80%) of interferon is noted, in connection with which both local and pronounced systemic immunomodulatory action is achieved; When intravaginal application 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 action due to the low absorption capacity of the mucous membrane of the vagina is insignificant. Cmax interferon in the serum is achieved 5 hours after the administration of the drug. The main way of excretion is through the kidneys. T1 / 2 is 12 hours, which necessitates the use of the drug 2 times a day.

Indications for the drug Genferon

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, gardnerellez, trichomoniasis, papillomavirus infection, bacterial vaginosis, cervical erosion, cervicitis, vulvovaginitis, bartholinitis, 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.

With caution: exacerbation of allergic and autoimmune diseases.

Application in pregnancy and breastfeeding

The use of local immunity for normalization of the indices of local immunity at the gestation period of 13-40 weeks is shown in 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 part of the urogenital tract.

Clinical studies have shown the safety of intravaginal application of the drug Genferon® 250000 IU at the time of pregnancy 13-40 weeks.

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

Side effects

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 occurring when all types of interferon alfa-2b are used, such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, and leukemia and thrombocytopenia, but more often they occur at a significant Exceeding the daily dose of more than 10,000,000 IU. So far, no serious side effects have been observed.

As for any other interferon alpha-2b preparation, in the case of an increase in temperature after its administration, a single dose of paracetamol in 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 increase the effect of benzocaine.

Benzocaine reduces the antibacterial activity of sulfonamides.

Dosing and Administration

Vaginally, rectally.

Infectious and inflammatory diseases of the urogenital tract in women. For 1 soup. (250,000, 500,000 or 1,000,000 IU, depending on the severity of the disease) vaginally or rectally (depending on the nature of the disease) 2 times daily for 10 days. With prolonged forms 3 times a week every other day, one soup. For 1-3 months.

With a pronounced infectious-inflammatory process in the vagina, 1 supp is possible. (500,000 IU) intravaginally in the morning and 1 supp. (1,000,000 IU) rectally at night, simultaneously with the introduction into the vagina of a suppository containing antibacterial / fungicidal agents.

To normalize the indices of local immunity in the treatment of infectious and inflammatory diseases of the urogenital tract in women with gestational periods of 13-40 weeks, 1 supp is used. 250000 IU vaginally 2 times a day, daily for 10 days.

Infectious and inflammatory diseases of the urogenital tract in men. Rectal by 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). For 1 soup. (1000000 IU) rectally 2 times a day for 5 days.

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

Overdose

No cases of an overdose of Genferon® were reported. If you accidentally inject a larger number of suppositories than prescribed by your doctor, you should stop the further administration for 24 hours, after which the treatment can be resumed according to the prescribed scheme.

Special instructions

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

Allowed use of the drug during menstruation.

Influence on the ability to drive vehicles and mechanisms. Genferon® does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (management of vehicles, machinery, etc.).

Release form

Vaginal or rectal suppositories, 55 mg + 250000 IU + 10 mg, 55 mg + 500,000 IU + 10 mg, 55 mg + 1,000,000 IU + 10 mg. By 5 soups. In a planar cell box made of aluminum foil or PVC film. 1 or 2 contour squares are placed in a pack of cardboard.

Manufacturer

ZAO "BIOKAD", 198515, Russia, St. Petersburg

Produced: BIOKAD CJSC, 143422, Russia, Moscow Region

Complaints on the drug should be sent to the FGBU State Institute for Standardization and Control of Medical Biological Preparations. L.A. Tarasevich Ministry of Health of Russia

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Genferon

At a temperature of 2-8 ° C.

Keep out of the reach of children.

The shelf life of the drug Genferon

2 years.

Do not use beyond the expiration date printed on the package.