Active substanceUmifenovirUmifenovir
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  • Dosage form: & nbspPowder for suspension for oral administration
    Composition:

    5 ml formulation:

    active substance: umiphenovir (umifenovir hydrochloride monohydrate - 25.88 mg), (in terms of umifenovir hydrochloride - 25.00 mg);

    Excipients: sodium chloride - 26.85 mg, maltodextrin (Liptospace Kleptose) 750.00 mg, sucrose (sugar) 840.42 mg, silicon dioxide colloid (aerosil) 24.60 mg, titanium dioxide 25.00 mg, starch pregelatinized (type PA5PH) - 129,50 mg, sodium benzoate - 9,25 mg, banana flavor - 12,40 mg, cherry flavoring - 6,10 mg.

    Description:

    Granular powder white or almost white with a characteristic fruity odor.

    Description of the prepared suspension: a homogeneous suspension of white or white with a yellowish or creamy hue of color with a characteristic fruity odor.

    Pharmacotherapeutic group:Antiviral agent
    ATX: & nbsp

    J.05.A.X.13   Umifenovir

    Pharmacodynamics:

    An antiviral agent. Specifically suppresses in vitro influenza A and B viruses (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other viruses - pathogens ARVI (coronavirus (Coronavirus), associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)). By the mechanism of antiviral action refers to the inhibitors of fusion (fusion), interacts with the hemagglutinin of the virus and prevents the fusion of the lipid envelope of the virus and cell membranes. Has interferon-inducing activity - in the study on mice, the induction of interferons was observed already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immunity reactions: increases the number of lymphocytes in the blood, in particular T cells (Cd3), increases the number of T-helpers (Cd4), without affecting the level of T-suppressors (Cd8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killers (NKcells).

    The therapeutic efficacy in viral infections is manifested in a decrease in the duration and severity of the course of the disease and its underlying symptoms,as well as in reducing the incidence of complications associated with a viral infection and exacerbations of chronic bacterial diseases.

    Refers to low-toxic drugs (LD50>4 g / kg). Does not have any negative effects on the human body when administered orally at recommended doses.
    Pharmacokinetics:

    Quickly absorbed and distributed to organs and tissues. The maximum concentration in the blood plasma when taking the drug at a dose of 200 mg of umifenovir is reached after 1 hour, the volume of distribution (Vd) - 1432 liters. Metabolised in the liver. The half-life on the average is 11 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and, in a small amount, kidney (0.12%). During the first day, 90% of the administered dose is withdrawn.

    Indications:

    - Prevention and treatment of influenza A and B, other acute respiratory viral infections in children from 2 years of age and adults;

    - complex therapy of acute intestinal infections of rotavirus etiology in children with 2 beds;

    - nonspecific prevention of severe acute respiratory syndrome (SARS) in children from 6 years of age and adults;

    - treatment of severe acute respiratory syndrome (SARS) in children older than 12 years and adults.

    Contraindications:

    Hypersensitivity to umifenovir or any component of the drug.

    Age to 2 years: age to 6 years (according to indications nonspecific prophylaxis of SARS); age up to 12 years (according to the indication of SARS treatment).

    Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

    Pregnancy and lactation:

    The use of Arbidol® during pregnancy is contraindicated. It is not known whether the active substance of Arbidol® or its metabolites penetrates into breast milk in women in lactation period. If the use of the drug Arbidol® should stop breastfeeding.

    Dosing and Administration:

    Inside, before eating.

    Preparation of the suspension.

    In a vial containing a powder, add 30 ml (or approximately 2/3 of the volume of the vial) of boiled and cooled to room temperature water. The vial is closed with a lid, turned over and shaken carefully until a uniform suspension is obtained. Add boiled and cooled water to a volume of 100 ml (until the label on the vial) and shake again. Before each intake, the contents of the vial should be shaken carefully until a uniform suspension is obtained. Single dose metered using the attached measuring spoon.

    Single dose (depending on age):

    Age

    Single dose of the drug, ml of suspension (mg of Umifenovir)

    from 2 to 6 years

    10 ml (50 mg)

    from 6 to 12 years

    20 ml (100 mg)

    over 12 years and adults

    40 ml (200 mg)

    Indication

    Scheme of drug administration

    In children from 2 years of age and adults:

    Nonspecific prevention during the epidemic of influenza and other ARVI

    in a single dose 2 times a week for 3 weeks.

    Nonspecific prophylaxis in direct contact with patients with influenza and other ARVI

    in a single dose once a day for 10-14 days.

    Treatment of influenza and other acute respiratory viral infections in uncomplicated course

    in a single dose 4 times a day (every 6 hours) for 5 days.

    In children from 2 years:

    Complex therapy of acute intestinal infections of rotavirus etiology

    in a single dose 4 times a day (every 6 hours) for 5 days.

    For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS):

    For nonspecific prevention of SARS (in contact with the patient) in children from 6 years of age and adults:

    children from 6 to 12 years old - 20 ml (100 mg), children over 12 years and adults - 40 ml (200 mg) once a day for 12-14 days.

    For the treatment of SARS in children from 12 years of age and adults:

    children over 12 years and adults - 40 ml (200 mg) 2 times a day for 8-10 days.

    Side effects:

    Allergic reactions: rarely (with a frequency of not less than 1/10000, but less than 1/1000) - skin itching, rash, angioedema, urticaria; very rarely (with a frequency of less than 1/10 000) - anaphylactic reactions.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:Not checked.
    Interaction:

    In the appointment with other drugs, no negative effects were noted.

    Special instructions:

    When appointing patients with diabetes, as well as with a low-calorie diet, it must be taken into account that sucrose is included in the suspension (0.8 g / 5 ml or 0.06 XE / 5 ml). It is necessary to follow the recommended in the instructions scheme and the duration of the drug. If you miss one dose of the drug - the missed dose should be taken as soon as possible and continue the course of taking the drug according to the scheme started.

    When calculating the amount of suspension necessary for the course of administration, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. On the course of admission on the basis of indications nonspecific prophylaxis during the epidemic of influenza and other acute respiratory viral infections in children From 2 to 6 years, two bottles of Arbidol® are needed.

    Effect on the ability to drive transp. cf. and fur:

    It does not show central neurotropic activity and can be used in medical practice in persons of various professions, including requiring increased attention and coordination of movements (drivers of transport, operators, etc.).

    Form release / dosage:

    Powder for suspension for oral administration, 25 mg / 5 ml.

    Packaging:

    For 37 g in bottles with a capacity of 125 ml (labeled to a level of 100 ml) of dark (amber) glass.

    One bottle together with the instruction for use and a measuring spoon is placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    The prepared suspension should be stored at a temperature not exceeding 8 ° C (in the refrigerator). Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    Powder for suspension for oral administration - 2 years.

    The prepared suspension is no more than 10 days.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003117
    Date of registration:29.07.2015 / 12.08.2016
    Expiration Date:29.07.2020
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.09.2017
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