Genferon light nasal drops 10000IU/ml+0.8mg/ml fl 10ml
Registration Certificate Holder
BIOCAD (Russia)
Dosage form
Medicine - Genferon® Light (Genferone Light)
Description
Nasal drops
transparent, colorless or light yellow.
1 ml
interferon alpha-2b human recombinant* 10,000 IU taurine 0.8 mg
* the substance “Human recombinant interferon alpha-2b (rhIFN-α2b)” includes excipients: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injection.
Excipients
: disodium edetate dihydrate - 0.02 mg, glycerol - 7 mg, dextran 35-45 thousand - 2.4 mg, polysorbate 80 - 1 mg, sodium chloride - 0.8 mg, potassium chloride - 0.02 mg, sodium hydrogen phosphate - 0.115 mg, sodium dihydrogen phosphate - 0.02 mg, water d/i - up to 1 ml.
10 ml - dark glass bottles (1) complete with a dropper attachment - cardboard packs.
Indications
- treatment of influenza and other acute respiratory viral infections in children aged 29 days to 14 years.
Contraindications for use
- hypersensitivity to interferon alfa-2b or other components of the drug;
- newborns from 0 to 28 days (due to lack of clinical data).
pharmachologic effect
The drug Genferon Light, nasal drops, has antiviral, immunomodulatory, anti-inflammatory, antiproliferative, antibacterial effects, has local regenerating, membrane-stabilizing and antioxidant properties. Interferon alpha blocks the proliferation of viruses at the stage of synthesis of specific proteins and prevents infection of uninfected cells of the nasal mucosa, which is the site of pathogen invasion and the primary focus of inflammation during respiratory infections. The immunomodulatory effect is manifested by an increase in cell-mediated reactions of the immune system, which increases the effectiveness of the immune response against foreign agents. This is achieved through the activation of CD8+ T-killers, 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 main histocompatibility complex type 1, 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, restoration of the production of secretory immunoglobulin A is achieved. The antibacterial effect is mediated by reactions of the immune system, enhanced by the iodine influence of interferon.
Taurine, which is part of the drug, normalizes metabolic processes in tissues, promotes regeneration and faster restoration of the nasal mucosa damaged by the pathological process.
Drug interactions
The simultaneous use of intranasal vasoconstrictor drugs is not recommended, as this causes additional dryness of the nasal mucosa.
Dosage regimen
At the first signs of the disease, Genferon Light is instilled into the nose for 5 days.
Children from 29 days to 11 months 29 days
- 1 drop in each nasal passage 5 times a day (single dose 1,000 IU, daily dose 5,000 IU).
Children from 1 to 3 years old
- 2 drops in each nasal passage 3-4 times a day (single dose 2,000 IU; daily dose 6,000-8,000 IU).
Children from 3 to 14 years old
- 2 drops in each nasal passage 4-5 times a day (single dose 2,000 IU, daily dose - 8,000-10,000 IU).
Overdose
Cases of overdose of the drug Genferon Light have not been registered to date.
Side effect
Local allergic reactions (burning sensation, itching) are possible. These phenomena are reversible and disappear on their own within 72 hours after stopping the use of the drug. Continuation of treatment is possible only after consultation with a doctor.
special instructions
After instillation, it is recommended to massage the wings of the nose with your fingers for several minutes to evenly distribute the drug in the nasal cavity.
Effect on the ability to drive vehicles and operate machinery
The effect of the drug Genferon Light on the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, machinery, etc.) has not been studied.
Storage conditions
In a dry place, protected from light, at a temperature of 2 to 8°C.
Within the stated expiration date, patients can store the drug after opening for 7 weeks at a temperature of 2 to 8°C.
Keep out of the reach of children.
Best before date
Shelf life: 2 years.
Use during pregnancy and breastfeeding
Not used because the drug is indicated for use in children aged 29 days to 14 years.
Use in children
Restrictions for children - With caution.
Contraindicated in newborns up to 28 days.
Terms of sale
On prescription.
Genferon Light drops naz 10 thousand IU/ml+0.8 mg/ml 10 ml x1
Genferon Light drops naz 10 thousand IU/ml+0.8 mg/ml 10 ml x1 ATX code: L03A (Immunostimulants)
Active substances
taurine Rec.INN registered by WHO interferon alfa-2b USAN accepted for use in the USA
Dosage form
GENFERON® LIGHT
nasal drops 10,000 IU+0.8 mg/1 ml: vial. 10 ml with dropper nozzlereg. No.: LP-002309 dated 11/25/13 - Valid
Release form, packaging and composition of Genferon Light
Nasal drops are transparent, colorless or light yellow.
1 ml
interferon alpha-2b human recombinant* 10,000 IU
taurine 0.8 mg
* the substance “Human recombinant interferon alpha-2b (rhIFN-α2b)” includes excipients: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injection.
Excipients: disodium edetate dihydrate - 0.02 mg, glycerol - 7 mg, dextran 35-45 thousand - 2.4 mg, polysorbate 80 - 1 mg, sodium chloride - 0.8 mg, potassium chloride - 0.02 mg, sodium hydrogen phosphate - 0.115 mg, sodium dihydrogen phosphate - 0.02 mg, water for injection - up to 1 ml.
10 ml - dark glass bottles (1) complete with a dropper attachment - cardboard packs.
Clinical and pharmacological group: Interferon. Immunomodulatory drug with antiviral effect Pharmacotherapeutic group: Immunomodulatory agent
pharmachologic effect
The drug Genferon Light, nasal drops, has antiviral, immunomodulatory, anti-inflammatory, antiproliferative, antibacterial effects, has local regenerating, membrane-stabilizing and antioxidant properties. Interferon alpha blocks the proliferation of viruses at the stage of synthesis of specific proteins and prevents infection of uninfected cells of the nasal mucosa, which is the site of pathogen invasion and the primary focus of inflammation during respiratory infections. The immunomodulatory effect is manifested by an increase in cell-mediated reactions of the immune system, which increases the effectiveness of the immune response against foreign agents. This is achieved through the activation of CD8+ T-killers, 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 main histocompatibility complex type 1, which increases the likelihood recognition of infected cells by cells of the immune system. Activation of leukocytes contained in all layers of the mucous membrane under the influence of interferon ensures their active participation in the elimination of pathological foci; in addition, due to the influence of interferon, the production of secretory immunoglobulin A is restored. The antibacterial effect is mediated by reactions of the immune system, enhanced by the iodine influence of interferon.
Taurine, which is part of the drug, normalizes metabolic processes in tissues, promotes regeneration and faster restoration of the nasal mucosa damaged by the pathological process.
Pharmacokinetics
When used intranasally, the drug Genferon Light, nasal drops, creates a high concentration of interferon at the site of infection and has a pronounced local antiviral and immunostimulating effect. Systemic absorption of the drug is insignificant; with intranasal administration, recombinant human interferon alpha-2b is detected in small quantities in the lung tissue and blood. In the body, biotransformation occurs predominantly in the kidneys with a T1/2 of 5.1 hours. A small amount of the drug entering the systemic circulation has a systemic immunomodulatory effect.
Indications for the drug Genferon Light
treatment of influenza and other acute respiratory viral infections in children aged 29 days to 14 years. ICD-10 codes
ICD-10 code Indication
J06.9 Acute upper respiratory tract infection, unspecified
J10 Influenza caused by an identified influenza virus
Dosage regimen
At the first signs of the disease, Genferon Light is instilled into the nose for 5 days.
Children from 29 days to 11 months 29 days - 1 drop in each nasal passage 5 times a day (single dose 1,000 IU, daily dose 5,000 IU).
Children from 1 to 3 years old - 2 drops in each nasal passage 3-4 times a day (single dose 2,000 IU; daily dose 6,000-8,000 IU).
Children from 3 to 14 years old - 2 drops in each nasal passage 4-5 times a day (single dose 2,000 IU, daily dose - 8,000-10,000 IU).
Side effect
Local allergic reactions (burning sensation, itching) are possible. These phenomena are reversible and disappear on their own within 72 hours after stopping the use of the drug. Continuation of treatment is possible only after consultation with a doctor.
Contraindications for use
hypersensitivity to interferon alfa-2b or other components of the drug, newborns from 0 to 28 days (due to the lack of clinical data).
Use during pregnancy and breastfeeding
Not used because the drug is indicated for use in children aged 29 days to 14 years.
Use in children Contraindicated in newborns up to 28 days.
special instructions
After instillation, it is recommended to massage the wings of the nose with your fingers for several minutes to evenly distribute the drug in the nasal cavity.
Impact on the ability to drive vehicles and operate machinery
The effect of the drug Genferon Light on the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, machinery, etc.) has not been studied.
Overdose
Cases of overdose of the drug Genferon Light have not been registered to date.
Drug interactions
The simultaneous use of intranasal vasoconstrictor drugs is not recommended, as this causes additional dryness of the nasal mucosa.
Storage conditions for Genferon Light
In a dry place, protected from light, at a temperature of 2 to 8°C.
Within the stated expiration date, patients can store the drug after opening for 7 weeks at a temperature of 2 to 8°C.
Keep out of the reach of children.
Shelf life of Genferon Light Shelf life - 2 years.
Terms of sale Without a prescription.
Genferon Light spray, 1 piece, 50000 IU+1 mg/dose, dosed nasal spray
Vaginal or rectal suppositories:
vaginal, rectal.
The route of administration, dosage and course duration depend on age and the specific clinical situation. 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, 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 at a dose of 250,000 IU of 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, after a 5-day treatment period, 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 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 sup. rectally 2 times a day with a 12-hour interval for 10 days, against the background of specific therapy prescribed and supervised by a doctor.
Infectious and inflammatory diseases of the urogenital tract in pregnant women:
1 sup. (250,000 IU) vaginally 2 times a day with a 12-hour interval for 10 days, against the background of specific therapy prescribed and supervised by a doctor.
Infectious and inflammatory diseases of the urogenital tract in women:
1 sup. (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, against the background of specific therapy prescribed and supervised by a doctor. For prolonged forms, 3 times a week every other day, 1 sup. within 1–3 months.
Dosed nasal spray:
intranasally,
by aerosol administration of 1 dose (1 dose = 1 short press on the dispenser).
At the first signs of the disease, Genferon® Light is administered intranasally for 5 days, one dose (one press on the dispenser) into each nasal passage 3 times a day (one dose is approximately 50,000 IU of interferon alfa-2b, the daily dose should not exceed 500,000 IU).
In case of contact with a patient with acute respiratory viral infection and/or hypothermia, the drug is administered according to the indicated regimen 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 stream appears.
3. When using, keep the bottle in an upright position.
4. Inject the drug by pressing the dispenser once into each nasal passage in turn.
5. After use, close the dispenser with the protective cap.
To avoid the spread of infection, individual use is recommended.
