Genferon - instructions for use

Nosological classification (ICD-10)

— A49.3 Mycoplasma infection, unspecified — A56 Other sexually transmitted chlamydial diseases — A59 Trichomoniasis — A60 Anogenital herpetic viral infection [herpes simplex] — A63.8 Other specified sexually transmitted diseases — B37.3 Vulvar candidiasis and vagina (N77.1) - B97.7 Papillomaviruses - N34 Urethritis and urethral syndrome - N41 Inflammatory diseases of the prostate gland - N48.1 Balanoposthitis - N48.6 Balanitis - N70 Salpingitis and oophoritis - N72 Inflammatory diseases of the cervix - N74.4 Inflammatory diseases of the female pelvic organs caused by chlamydia (A56.1+) - N75.9 Bartholin's gland disease, unspecified - N76 Other inflammatory diseases of the vagina and vulva - N86 Erosion and ectropion of the cervix

Contraindications and indications from the instructions for Genferon

Rectal or vaginal suppositories are prescribed for adults and children. In the latter case, the drug Genferon Light is used. The medication is suitable for the complex treatment of individual pathologies that provoke inflammation of the genitourinary

department:

for chlamydia, genital herpes;
mycoplasmosis, ureaplasmosis;
gardnerellosis, HPV;
trichomoniasis, bacterial vaginosis;
cervical erosion, vulvovaginitis;
cervicitis, adnexitis;
urethritis, balanitis, bartholinitis;
prostatitis, balanoposthitis;
thrush.

Genferon is contraindicated in patients with individual intolerance to the component composition in the first 4 months of pregnancy. Caution during therapeutic procedures is necessary for patients with acute diseases affecting the immune system.

Composition and release form

Suppositories for vaginal or rectal use 1 sup.
- active substances: -
human recombinant interferon alpha-2 250000 IU
- taurine 0.01 g - anesthesin 0.055 g - excipients: solid fat; dextran 60000; polyethylene oxide 1500; twin 80; emulsifier T 2; sodium citrate; citric acid; purified water - sufficient quantity to obtain a suppository weighing 1.65 g in a blister pack of 5 pcs.; in a cardboard pack 1 or 2 packages.

active substances: - human recombinant interferon alpha-2 500000 IU

- taurine 0.01 g - anesthesin 0.055 g - excipients: solid fat; dextran 60000; polyethylene oxide 1500; twin 80; emulsifier T 2; sodium citrate; citric acid; purified water - sufficient quantity to obtain a suppository weighing 1.65 g in a blister pack of 5 pcs.; in a cardboard pack 1 or 2 packages.

active substances: - human recombinant interferon alpha-2 1 million IU

Features of therapy

The instructions recommend the following procedures with Genferon:

Infectious and inflammatory pathologies of the genitourinary tract in women - depending on the disease, a suppository twice a day, for 10 days. Chronic and long-term forms of diseases - 1 suppository every 24 hours, for 1-3 months.
Lesions of the urogenital tract in men of an infectious-inflammatory nature - 1 suppository in the morning and evening, for 10 days.

The abstract does not indicate any reported cases of overdose. If a large amount of medication is accidentally used, therapy is stopped for 24 hours, then the patient should return to the previously prescribed regimen. If the treatment has caused non-standard symptoms, the patient should attend a consultation with a doctor and describe in detail the changes that have occurred. In some cases, it is necessary to replace the drug with an analogue.

Pharmacodynamics

Genferon® is a combination drug, the effect of which is determined by the components included in its composition.
Has local and systemic effects. Interferon alpha-2 has antiviral, antimicrobial and immunomodulatory effects. Under the influence of interferon alpha-2, the activity of natural killer cells, T-helper cells, phagocytes, as well as the intensity of differentiation of B-lymphocytes in the body increases. Activation of leukocytes contained in all layers of the mucous membrane ensures their active participation in the elimination of primary pathological foci and restoration of the production of secretory immunoglobulin A. Interferon alpha-2 also directly inhibits the replication and transcription of viruses and acts on chlamydia. Taurine has regenerating, reparative, membrane- and hepatoprotective, antioxidant, anti-inflammatory properties. Anestezin is a local anesthetic. Reduces the permeability of the cell membrane to sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane. Prevents the occurrence of pain impulses at the endings of sensory nerves and their conduction along nerve fibers.

Adverse reactions

Treatment with Genferon 10,000,000 IU can lead to non-standard responses of the body:

headache attacks, decreased levels of leukocytes and platelets in the blood;
painful sensations in joints and bones;
active work of sweat glands, increased temperature;
loss of appetite, rapid fatigue;
skin itching, rashes, and the appearance of red spots.

These symptoms are reversible and spontaneously disappear three days after stopping the suppositories.

GENFERON SUPP 500 THOUSAND IU No. 10

Compound

Active substances: interferon alpha-2b (rhIFN-α-2b) - 125000/500000IU;
taurine - 0.005 g Excipients: solid fat; dextran 60000; macrogol 1500; polysorbate 80; emulsifier T2; sodium hydrogen citrate; citric acid; purified water -qs until a suppository weighing 0.8 g is obtained

Description of the dosage form

Vaginal or rectal suppositories: white or white with a yellowish tint, cylindrical in shape with a pointed end, uniform in longitudinal section. An air rod or funnel-shaped depression is allowed on the cut.

pharmachologic effect

Pharmacological action - antioxidant, immunomodulatory, antiviral.

Pharmacodynamics

Suppositories are rectal or vaginal.

Immunobiological properties

Genferon® Light is a combination drug, the effect of which is determined by the components included in its composition.

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

Interferon alpha-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 reactions 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 through the activation of CD8+ T killer cells, NK cells (natural killer cells), 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 major histocompatibility complex type I, which increases the likelihood recognition of infected cells by cells of the immune system. Activation under the influence of interferon of 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, the production of secretory IgA is restored. The antibacterial effect is mediated by immune system reactions enhanced by interferon.

Taurine helps normalize metabolic processes and tissue regeneration, has membrane-stabilizing and immunomodulatory effects. 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 maintain the biological activity of interferon, enhancing the therapeutic effect of the drug.

Pharmacokinetics

With rectal administration of the drug, high bioavailability (more than 80%) of interferon is observed, and therefore both local and pronounced systemic immunomodulatory effects are achieved; when administered intravaginally, due to the high concentration at the site of infection and fixation on the cells of the vaginal mucosa, 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. Cmax of interferon in the blood serum is achieved after 5 hours after administration of the drug. The main route of elimination is through the kidneys. T1/2 is 12 hours, which necessitates the use of the drug 2 times a day.

Indications of the drug Genferon® Light

as a component of complex therapy - treatment of ARVI and other infectious diseases of bacterial and viral etiology in children;
treatment of infectious and inflammatory diseases of the urogenital tract in children and women, incl. pregnant women.

Contraindications

individual intolerance to interferon and other substances included in the drug;
I trimester of pregnancy.
With caution: exacerbation of allergic and autoimmune diseases.

Use during pregnancy and breastfeeding

Clinical studies have proven the effectiveness and safety of using the drug Genferon® Light in women who are 13–40 weeks pregnant. Use in the first trimester of pregnancy is contraindicated. There are no restrictions for use during lactation.

Side effects

The drug is well tolerated by patients. Local allergic reactions (itching and burning sensation in the vagina) are possible. These phenomena are reversible and disappear within 72 hours after cessation of administration. Continuation of treatment is possible after consultation with a doctor.

To date, no severe or life-threatening side effects have been observed. Phenomena that occur with the use of all types of interferon alfa-2b, such as chills, fever, fatigue, loss of appetite, muscle and headaches, joint pain, sweating, as well as leukemia and thrombocytopenia, may be observed, but more often they occur with significant exceeding the daily dose over 10,000,000 IU. In these cases, it is recommended to consult your doctor to decide whether to discontinue the drug or reduce the dose.

As with any other interferon alfa drug, if the temperature rises after its administration, a single dose of paracetamol is possible in a dose of 500–1000 mg for adults and 250 mg for children.

Interaction

Genferon® Light is most effective as a component of complex therapy. When combined with antibacterial, fungicidal and antiviral drugs, mutual potentiation of action is observed, which makes it possible to achieve a high total therapeutic effect.

Directions for use and doses

The method of administration, dosage and course duration depend on age, the specific clinical situation and are determined by the attending physician. In adults and children over 7 years of age, Genferon® Light is used in a dosage of 250,000 IU of interferon alfa-2b per suppository. In children under 7 years of age, it is safe to use the drug at a dosage of 125,000 IU of interferon alfa-2b per suppository. In women who are 13–40 weeks pregnant, the drug is used at a dose of 250,000 IU interferon alfa-2b per suppository.

Recommended dosages and treatment regimens

ARVI and other acute viral diseases in children: 1 sup. rectally 2 times a day with a 12-hour interval in parallel with the main therapy for 5 days. If symptoms persist, the course of treatment is repeated after a 5-day interval.
Chronic infectious and inflammatory diseases of viral etiology in children: 1 sup. rectally 2 times a day with a 12-hour interval simultaneously with standard therapy for 10 days. Then for 1–3 months - 1 sup. rectally at night every other day.
Acute infectious and inflammatory diseases of the urogenital tract in children: 1 supp. rectally 2 times a day with a 12-hour interval for 10 days.
Infectious and inflammatory diseases of the urogenital tract in pregnant women: 1 supp. vaginally 2 times a day with a 12-hour interval for 10 days.
Infectious and inflammatory diseases of the urogenital tract in women: 1 supp. (250,000 IU) vaginally or rectally (depending on the nature of the disease) 2 times a day with a 12-hour interval for 10 days. For prolonged forms, 3 times a week every other day, 1 sup. within 1–3 months.

Overdose

Cases of overdose of Genferon® Light have not been registered. If you accidentally administer more suppositories at a time than were prescribed by your doctor, further administration should be suspended for 24 hours, after which treatment can be resumed according to the prescribed regimen.

special instructions

Impact on the ability to drive vehicles and machinery. Genferon® Light does not affect the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, machinery, etc.).

Release form

Vaginal or rectal suppositories, 125000IU+5 mg, 500000IU+5 mg. 5 supp. in blister packs made of aluminum foil or PVC film. 1 or 2 blister packs are placed in a cardboard pack.

, 198515, Russia, St. Petersburg, Petrodvortsovy district, Strelna village, st. Communications, 34, Lit. A.

Manufactured by: JSC "BIOCAD", Russia, 143422, Moscow region, Krasnogorsk district, village. Petrovo-Dalnee.

Conditions for dispensing from pharmacies

On prescription.

Storage conditions for the drug Genferon® Light

In a dry place, protected from light, at a temperature of 2–8 °C.
Keep out of the reach of children.

Shelf life of the drug Genferon® Light

2 years.

Do not use after the expiration date stated on the package.

Analogs

If unusual reactions of the body or signs of intolerance to the component composition occur, the drug requires replacement. The list of analogues is presented:

Vitaferon, Viferon, Viferon-Feron;
Laferobion, Laferon Farmbiotek, Kipferon;
Alfarekin, Alfarona, Bioferon;
Virogel, Gerpferon, Grippferon;
Introbion interferon alpha-2b, Intron A;
Lipoferon, Okoferon, Realdiron, etc.

The selection of a suitable remedy is carried out by the attending physician.

Reviews

On the forums there are both neutral and positive responses about Genferon. Most reviews are related to treatment procedures in women during therapy for HPV, herpetic and cytomegalovirus infections. Good clinical results occur when treated with suppositories of 1 million IU.

Deterioration in well-being and an increase in temperature are associated with large dosages, especially when using suppositories for minors. To avoid the development of adverse reactions, the patient must strictly follow the doctor’s instructions, without deviations from the original regimen.

Nuances of interaction and manufacturer's instructions

The instructions indicate the following features:

taking vitamins C and B enhances the activity of Genferon;
the bactericidal and bacteriostatic activity of sulfonamides decreases when combined with benzocaine;
Non-narcotic analgesics improve the effectiveness of benzocaine.

The greatest results with therapy with Genferon are recorded when combined with antimicrobial medications. The drug must be used with caution during menstruation due to the lack of sufficient clinical trials.

The drug is incompatible with alcohol; you should avoid drinking alcohol during therapeutic procedures. In the 2-3 trimester of pregnancy, the medication is used when obsessive itching, discomfort and other symptoms occur caused by an infectious-inflammatory lesion of the genitourinary tract.