Instruction for use: Genferon Lite

Dosage form: Nasal drops; Nasal dosing spray; Vaginal / rectal suppositories

Active substance: Interferonum alpha-2b + Taurinum

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 Bacterial infection of unspecified site: Bacterial infection; Infectious diseases

B34 Viral infection of unspecified site: Viral respiratory tract infections; Infections viral; Viral infection; Viral infections

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

N39.0 Urinary tract infection without established localization: Fungal infections of the urinary tract; Asymptomatic bacteriuria; Bacterial infections of the urinary tract; Bacterial infections of the urinary tract; Bacterial infections of the genitourinary system; Bacteriuria; Bacteriuria asymptomatic; Bacteriuria chronic latent; Asymptomatic bacteriuria; Asymptomatic massive bacteriuria; Inflammatory urinary tract disease; Inflammatory urinary tract disease; Inflammatory diseases of the bladder and urinary tract; Inflammatory diseases of the urinary system; Inflammatory diseases of the urinary tract; Inflammatory diseases of the urogenital system; Fungal diseases of the urogenital tract; Urinary Tract Infections; Urinary Tract Infections; Infections of the urinary system; Urinary tract infections; Urinary Tract Infections; Urinary tract infections caused by enterococci or mixed flora; Urinary tract infections uncomplicated; Urinary tract infections complicated; Infections of the urogenital system; Infections urogenital; Infectious diseases of the urinary tract; Urinary Tract Infection; Urinary tract infection; Urinary system infection; Urinary tract infection; Urinary tract infection; Infection of the urogenital tract; Uncomplicated urinary tract infections; Uncomplicated urinary tract infections; Uncomplicated urinary tract infections; Uncomplicated infections of the genitourinary system; Exacerbation of chronic urinary tract infection; Retrograde kidney infection; Recurrent urinary tract infections; Recurrent urinary tract infections; Recurrent infectious diseases of the urinary tract; Mixed urethral infections; Urogenital infection; Urogenital Infectious-Inflammatory Disease; Urogenital mycoplasmosis; Urologic disease of infectious etiology; Chronic urinary tract infection; Chronic inflammatory diseases of the pelvic organs; Chronic urinary tract infections; Chronic infectious diseases of the urinary system

N73.9 Inflammatory diseases of female pelvic organs, unspecified: Urogenital tract infections; Abscess of pelvic organs; Bacterial diseases of the urogenital tract; Bacterial infections of the genitourinary system; Bacterial infections of the pelvic organs; Intraluminal infections; Inflammation in the area of throat of the uterus; Inflammation of the organs of the small pelvis; Inflammatory disease of the pelvic organs; Inflammatory gynecological diseases; Inflammatory diseases of female pelvic organs; Inflammatory diseases of the pelvic organs; Inflammatory diseases of pelvic organs; Inflammatory infections in the pelvis; Inflammatory processes in the pelvis; Gynecological infection; Gynecological infections; Gynecological infectious diseases; Pyoinflammatory diseases of the pelvic organs; Infections of female genital organs; Infections of the pelvic organs in women; Infections of the pelvic organs; Infectious diseases of the reproductive system; Infectious diseases of genital organs; Infection of female genital organs; Metritis; Acute infection of female genital organs; Acute pelvic inflammatory disease; Tubo-ovarian inflammation; Chlamydial gynecological infections; Chronic inflammatory diseases of the pelvic organs; Chronic inflammatory diseases of appendages; Chronic infections of female genital organs; Pelvic infection

O23 Urinary tract infections in pregnancy: Urinary tract infection in pregnancy; Genitourinary infection in pregnant women; Chlamydial infections in pregnant women

Composition

Suppositories vaginal or rectal 1 supp.

Active substances: Interferon alpha-2b (rchIFN-α-2b) 125,000 IU

Taurine 0.005 g

Excipients: solid fat; Dextran 60000; Macrogol 1500; Polysorbate 80; Emulsifier T2; Sodium hydrocitrate; Citric acid; Purified water - q.s. Until a suppository of 0.8 g

Suppositories vaginal or rectal 1 supp.

active substance: Interferon alpha-2b (rchIFN-α-2b) 250000 IU

Taurine 0.005 g

Excipients: solid fat; Dextran 60000; Macrogol 1500; Polysorbate 80; Emulsifier T2; Sodium hydrocitrate; Citric acid; Purified water - q.s. Until a suppository of 0.8 g

Spray nasal dosed 1 dose

Active substances: Interferon alpha-2b human recombinant (rchIFN-α-2b) 50000 IU

Taurine 0.001 g

Auxiliary substances: disodium edetate dihydrate - 0.02 mg; Glycerol - 7 mg; Dextran 40000 - 2.4 mg; Polysorbate 80 - 1 mg; Sodium chloride - 0.8 mg; Potassium chloride - 0.02 mg; Sodium hydrophosphate dodecahydrate - 0.115 mg; Potassium dihydrogen phosphate - 0.02 mg; Peppermint oil - 0.01 mg; Methyl parahydroxybenzoate 0.02 mg; Water for injection - q.s.

Description of dosage form

Suppositories vaginal or rectal: 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.

Spray nasal dosed: clear, colorless or light yellow liquid, without visible mechanical inclusions.

Pharmachologic effect

Mode of action - antiviral, immunomodulating, antioxidant.

Pharmacodynamics

Suppositories rectal or vaginal, Spray nasal. Total information.

Immunobiological properties

Genferon® Light is a combined preparation, the effect of which is due to the components that make up its composition.

Genferon® Light contains the recombinant human interferon alpha-2b, produced by the Escherichia coli strain, into which the human interferon alpha-2b gene was introduced by genetic engineering techniques.

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.

Pharmacokinetics

Suppositories rectal or vaginal

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 of the vagina, 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.

Spray nasal

With intranasal application due to a high concentration in the focus of infection, a pronounced local antiviral and immunostimulating effect is achieved.

Systemic absorption of the drug is insignificant - low bioavailability of drugs with intranasal administration is associated with the functioning of a special family of proteins from the 25 proteins that make up the mucous membrane of the nasal cavity and control the transport of all molecular and cellular objects that penetrate the mucosa.

At the same time, a certain amount of the drug enters the systemic bloodstream, thereby achieving a systemic immunomodulatory effect.

Indication of the Genferon Lite

Vaginal or rectal suppositories

As a component of complex therapy - treatment of ARVI and other infectious diseases of bacterial and viral etiology in children;

For the treatment of infectious and inflammatory diseases of the urogenital tract in children and women, incl. Pregnant women, against a background of prescribed and controlled by a doctor specific therapy.

Spray nasal dosed

Prevention and treatment of influenza and ARVI in adults and children over 14 years of age.

Contraindications

Vaginal or rectal suppositories

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

I trimester of pregnancy.

Spray nasal dosed

Hypersensitivity to interferon alpha-2b or other components of the drug;

Children's age till 14 years.

Carefully

Vaginal or rectal suppositories

Exacerbation of allergic and autoimmune diseases

Spray nasal dosed

Patients suffering from nosebleeds.

Application in pregnancy and breastfeeding

Vaginal or rectal suppositories

Clinical studies have shown the efficacy and safety of using the drug Genferon® Light in women who are at 13-40 weeks of gestation. Application in the first trimester of pregnancy is contraindicated. Has no limitations to use during lactation.

Spray nasal dosed

It is allowed to use during the entire period of pregnancy.

Side effects

Vaginal or rectal suppositories

The drug is well tolerated by patients. Very rarely (frequency is less than 1 per 10,000 cases) - there are isolated reports of cases of allergic reactions. These phenomena are reversible and disappear within 72 hours after discontinuation of administration. Continuation of treatment is possible after consultation with a doctor.

To date, no serious or life-threatening side effects have been observed.

Spray nasal dosed

Side effects were not observed.

Interaction

Vaginal or rectal suppositories

Genferon® Light is most effective as a component of complex therapy. When combined with antibacterial, fungicidal and antiviral drugs, there is a mutual potentiation of the action, which allows achieving a high total therapeutic effect.

Spray nasal dosed

Not marked.

Dosing and Administration

Suppositories are vaginal or rectal: vaginal, rectal.

The mode of administration, dosage and duration of the course depend on the age, the specific clinical situation. In adults and children over the age of 7, Genferon® Light is used in a dosage of 250,000 IU of interferon alfa-2b for a suppository. In children under 7 years, including infants, 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 in a dose of 250,000 IU of interferon alfa-2b on the suppository.

Recommended doses and treatment regimens

SARS and other acute diseases of viral nature in children: 1 supp. Rectally 2 times a day with a 12-hour interval in parallel with the main therapy for 5 days. If after 5 days of treatment the symptoms of the disease do not decrease or become more pronounced, the patient should consult a doctor. According to clinical indications, it is possible to repeat the course of treatment after a 5-day interval.

Chronic infectious and inflammatory diseases of viral etiology in children: 1 supp. Rectally 2 times a day with a 12-hour interval simultaneously with standard therapy for 10 days. Then within 1-3 months - 1 soup. Rectally at night every other day.

Acute infectious-inflammatory diseases of the urogenital tract in children: 1 supp. Rectally 2 times a day with a 12-hour interval within 10 days, against a background of the specific therapy prescribed and controlled by the doctor.

Infectious and inflammatory diseases of the urogenital tract in pregnant women: 1 supp. (250,000 IU) vaginally 2 times a day with a 12-hour interval for 10 days, against a background of prescribed and controlled by the doctor specific therapy.

Infectious and inflammatory diseases of the urogenital tract in women: 1 supp. (250000 IU) vaginally or rectally (depending on the nature of the disease) 2 times a day with a 12-hour interval for 10 days, against a background of prescribed and controlled by the doctor specific therapy. With prolonged forms 3 times a week every other day, one soup. For 1-3 months.

Sprays nasal dosed: intranasally, by aerosol administration of 1 dose (1 dose = 1 short press on the dispenser).

At the first sign of the disease, Genferon® Light is administered intranasally for 5 days at a single dose (one push on the dispenser) to each nasal passage 3 times a day (one dose of approximately 50,000 IU of interferon alfa-2b, daily should not exceed 500,000 IU).

When in contact with a patient with acute respiratory viral infection and / or with supercooling, the drug is administered according to the indicated schedule 2 times a day for 5-7 days. If necessary, preventive courses are repeated.

Instructions for use of the spray

1. Remove the protective cap.

2. Before using for the first time, press the dispenser several times until a thin jet appears.

3. When applying, keep the bottle in a vertical position.

4. Produce the injection of the drug with a single pressure on the dispenser in each nasal passage alternately.

5. After application, close the dispenser with a protective cap.

Individual use is recommended to avoid the spread of infection.

Overdose

Vaginal or rectal suppositories

Cases of overdose of Genferon® Light are not registered. 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.

Spray nasal dosed

No cases of an overdose of Genferon® Light were reported.

Special instructions

Vaginal or rectal suppositories

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

Release Form

Suppositories vaginal or rectal, 125000 IU + 5 mg, 250,000 IU + 5 mg. By 5 soups. In a planar cell box made of aluminum foil or PVC film. 1 or 2 contour squares in a pack of cardboard.

Spray nasal dosed. For 100 doses in a vial of dark glass, sealed with a dispenser with a protective cap. On 1 fl. In a pack of cardboard.

Manufacturer

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

Produced: ZAO BIOCAD, 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

Suppositories vaginal or rectal 125000 IU + 5 mg. Without recipe.

Suppositories vaginal or rectal 250000 IU + 5 mg. On prescription.

Spray nasal dosed. Without recipe.

Storage conditions of the drug Genferon Lite

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Genferon Lite

2 years.

Do not use after the expiry date printed on the package.