Affinity-purified antibodies to human interferon gamma.
Each orodispersible tablet contains: Affinity-purified antibodies to human interferon gamma - 3 mg*.
* Water-ethanol mixture of the active substance dilutions (C12, C30 & C50) with concentration not more than la" ng/g used for saturation of lactose monohydrate.
Excipients/Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.
Pharmacotherapeutic Group: Antivirals. ATC Code: JO5AX.
Pharmacology: Pharmacodynamics: The medicine exerts antiviral effects upon prophylactic and therapeutic administration. Effectiveness is established experimentally and clinically towards influenza viruses, parainfluenza viruses, herpes simplex virus of type 1 and 2 (labial herpes, genital herpes), other herpes virus diseases (varicella, infectious mononucleosis), enterovirus, tick-borne encephalitis virus, rotavirus, coronavirus, calicivirus, adenovirus, respiratory syncytial virus. The drug reduces the concentration of virus in the affected tissues, influences on the system of endogenous interferons and related cytokines, induces the production of endogenous "early" interferons (IFN a/(3) and interferon gamma (IFN y).
The drug stimulates humoral and cell-mediated immune responses. Affinity-purified antibodies to human interferon gamma (Anaferon) increases antibody production (including secretory IgA), activates the functions of T-effectors and T-helpers (Th) and normalizes their ratio. The drug increases the functional reserves of Th and other cells involved in the immune response. The drug induces combined Th1 and Th2-type immune response through enhancing the production of Thl (IFN y, IL-2) and Th2 (IL-4, 10) cytokines, normalizes (modulates) the Thl/Th2 activity balance. The drug increases the functional activity of phagocytes and natural killer cells (NK cells).
Pharmacokinetics: The sensitivity of contemporary physicochemical methods (gas-liquid chromatography, high performance liquid chromatography and mass spectrometry) does not allow assessing the content of active components of the drug in biological fluids, organs and tissues, that makes technically impossible to investigate the pharmacokinetic properties of Affinity-purified antibodies to human interferon gamma (Anaferon).
Prophylaxis and treatment of influenza for children (6 months-14 years).
Affinity-purified antibodies to human interferon gamma (Anaferon) should be administered by children from 6 months to 14 years of age.
One tablet per intake (the tablet should be held in the mouth until it is completely dissolved, not during the meal).
When indicated to younger children (6 months - 3 years old) the tablet is recommended to be dissolved in a small volume (a tablespoonful) of drinking water at room temperature.
Influenza: On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2, one tablet is taken three times daily until complete recovery.
If no improvement occurs by the third day of treatment of acute respiratory virus infections and influenza, a doctor should be consulted.
Throughout the epidemic season for prophylaxis purposes the drug is administered 1 tablet daily for 1-3 months.
If necessary Affinity-purified antibodies to human interferon gamma (Anaferon) can be coadministered with other antiviral and symptomatic drugs.
Affinity-purified antibodies to human interferon gamma (Anaferon) is not recommended for use in children below age of 6 months due to a lack of data on safety and efficacy.
Overdose of this product can cause dyspeptic disorders due to excessive intake of excipients.
Treatment should be symptomatic.
Individual hypersensitivity to components of the medicine.
Medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Affinity-purified antibodies to human interferon gamma (Anaferon) has no or negligible influence on the ability to drive and use machines.
Use in Pregnancy: There are no or limited amount of data from the use of Affinity-purified antibodies to human interferon gamma (Anaferon) in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive/foetal toxicity. As a precautionary measure, it is preferable to avoid the use of Affinity-purified antibodies to human interferon gamma (Anaferon) during pregnancy.
Use in Lactation: It is unknown whether Affinity-purified antibodies to human interferon gamma (Anaferon) and/or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Affinity purified antibodies to human interferon gamma (Anaferon) should not be used during breast-feeding.
Allergic reactions and individual hypersensitivity to components of the medicine are possible.
Cases of incompatibility with other medicines have not been reported. if necessary the drug can be coadministered with other antiviral, antibacterial and symptomatic drugs.
Store at temperatures not exceeding 30°C.
J05AX - Other antivirals ; Used in the systemic treatment of viral infections.
Orodispersible tab 3 mg (white to off-white, round, flat, scored on one side and beveled tablets, marked MATERIA MEDICA on one side and ANAFERON KID on the other) x 20's.