Expiration date: 09/2025
The composition and form of issue:
Suppositories for vaginal or rectal use 1 supp. contains active substances:
interferon Alfa-2b of 125000, 250000 IU
taurine 0.005 g
auxiliary substances: solid fat dextran 60000 1500 macrogol Polysorbate 80 emulsifier T2 hydrocitrate sodium citric acid purified water — sufficient quantity to obtain the suppository mass 0.8 g
in a cells contour package 5 supp. in the paper cartons 1 or 2 packs.
Spray nasal dose 1 dose contains active substances:
interferon Alfa-2b human recombinant 50000 IU
taurine 1 mg
excipients: disodium edetate dihydrate glycerol dextran 40000 Polysorbate 80 sodium chloride potassium chloride disodium hydrogen phosphate dodecahydrate potassium dihydrogen peppermint oil methyl parahydroxybenzoate water for injections
in dark glass bottles, sealed dispenser with a protective cap in the paper cartons 1 a bottle.
Description pharmaceutical form:
Suppositories for vaginal or rectal applications: white or white with a yellowish sheen color, cylindrical shape with a pointed end, a longitudinal cut is homogeneous. The cut allowed the presence of air core or funnel-shaped depressions.
Spray nasal dose: transparent colorless or light yellow liquid, without visible mechanical inclusions.
Pharmacological action:
Immunomodulatory, antiviral, antibacterial, antiproliferative, regenerating.
Immunobiological properties
Genferon ® lite — combination drug whose action caused by components that are part of it. Having local and systemic action.
The drug genferon ® lite 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.
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 fixing the cells of the vaginal mucosa 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.
In intra application due to the high concentration at the source of the infection is achieved a pronounced local antiviral and immunostimulating effect.
Systemic absorption of the drug slightly low bioavailability of drugs when administered intranasally connected with the functioning of a particular family of proteins 25 proteins, members of the mucous membrane of the nasal cavity and controls the transport of all molecular and cellular objects penetrating through the mucosa.
At the same time, a certain amount of drug reaches the systemic circulation, thereby achieving a systemic immunomodulatory effect.
Indications:
- Suppositories for vaginal or rectal use
- as a component of complex therapy in the treatment of SARS and other infectious diseases of bacterial and viral etiology in children
- treatment of infectious-inflammatory diseases of the urogenital tract in women and children, including pregnant women.
Spray nasal dose
- prevention and treatment of influenza and ARVI in adults and children older than 14 years.
Contraindications:
- Suppositories for vaginal or rectal use
- individual intolerance of the interferon and other substances in the drug
- The first trimester of pregnancy.
Caution: aggravation of allergic and autoimmune diseases.
Spray nasal dose
- hypersensitivity to interferon Alfa-2b or other components of the drug
- children up to age 14 years.
Caution: patients suffering from epistaxis.
Application of pregnancy and breast-feeding:
Suppositories for vaginal or rectal use
Clinical studies have proven the effectiveness and safety of the drug genferon ® lite in women, located at 13-40 weeks of gestation. Use in the first trimester of pregnancy is contraindicated. Has no restrictions for use during lactation.
Spray nasal dose
Allowed to use during the entire pregnancy period.
Side effects:
Suppositories for vaginal or rectal use
The drug is well tolerated. Possible local allergic reactions (itching and 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.
Hitherto not experienced severe or life-threatening side effects. 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. In these cases, consult a physician to address the question about the necessity of drug withdrawal or dose reduction.
As with any other drug of interferon alpha in case of increase in temperature after the injection may be a single dose of paracetamol at a dose of 500-1000 mg for adults and 250 mg for children.
Spray nasal dose
Side effects were noted.
Drug interactions:
Suppositories for vaginal or rectal use
Genferon ® lite is most effective as a component of complex therapy. When combined with antibacterial, antifungal and antiviral drugs there is a mutual potentiation of the action, to achieve a higher total therapeutic effect.
Spray nasal dose
Not marked.
Method of application and dose:
Suppositories for vaginal or rectal use: vaginally, rectally.
The route of administration, dosage and duration of treatment depend on age, specific clinical situation and determined by your doctor. In adults and children older than 7 years genferon ® lite is used in a dosage of 250,000 IU interferon Alfa-2b on the suppository. In children up to 7 years is safe to use the drug in doses of 125,000 IU of interferon Alfa-2b on the suppository. The women in the 13-40 weeks of pregnancy, the drug used in a dose of 250,000 IU interferon Alfa-2b on the suppository.
Recommended doses and regimens
SARS and other acute diseases of viral nature in children: 1 supp. rectal 2 times in day with 12 hour intervals parallel to the main therapy for 5 days. When you save, symptoms, treatment is repeated after a 5-day interval.
Chronic infectious-inflammatory diseases of viral etiology in children: 1 supp. rectal 2 times in day with 12 hour intervals simultaneously with the standard therapy for 10 days. Then within 1-3 months — 1 supp. rectal the night across the day.
Acute infectious-inflammatory diseases of urogenital tract in children: 1 supp. rectal 2 times in day with 12 hour intervals for 10 days.
Infectious-inflammatory diseases of the urogenital tract of pregnant women: 1 supp. vaginally 2 times daily with 12-hour intervals for 10 days.
Infectious-inflammatory diseases of urogenital tract in women: 1 supp. (250,000 IU) vaginally or rectally (depending on the nature of the disease), 2 times a day with 12-hour intervals for 10 days. In protracted forms 3 times a week using day 1 supp. within 1-3 months.
Spray nasal dose: intranasal, by aerosol administration 1 dose (1 dose = 1 short push on the dispenser).
At the first sign of the disease genferon ® lite is administered intranasally for 5 days one dose (one push of the dispenser) in each nostril 3 times a day (one dose is approximately 50,000 IU of interferon Alfa-2b, daily should not exceed 500,000 IU).
In contact with a sick SARS and/or by supercooling the drug is administered according to the scheme 2 times a day for 5-7 days. If necessary, preventive courses should be repeated.
Instructions for use spray
1. Remove the protective cap.
2. Before use the first time you press the dispenser several times until the appearance of a thin jet.
3. When used to keep a bottle upright.
4. To produce the injection of the drug a single press on the dispenser in each nostril alternately.
5. After use close the spout with protective cap.
In order to avoid the spread of infection is recommended an individual use.
Overdose:
Suppositories for vaginal or rectal use
Cases of overdose genferon ® lite is not registered. 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.
Spray nasal dose
The cases of drug overdose genferon ® lite were reported.
Special instructions:
Suppositories for vaginal or rectal use
Genferon ® lite does not affect the performance of potentially hazardous activities that require special attention and fast reactions (driving, machinery, etc.).
