Arbidol pore. d / inv. suspension for oral administration 25mg / 5ml fl. 37g # 1 (cherry-banana)

Release form, composition and packaging

Powder for preparation of suspension for oral administration is granular, white or almost white in color, with a characteristic fruity odor

the prepared suspension is homogeneous, white or white with a yellowish or creamy shade, with a characteristic fruity odor.

5 ml ready-made suspension.

umifenovir hydrochloride monohydrate 25.88 mg,

- which corresponds to the content of umifenovir hydrochloride 25 mg

sodium chloride - 26.85 mg, maltodextrin (Kleptose Linecaps) - 750 mg, sucrose (sugar) - 840.42 mg, colloidal silicon dioxide (aerosil) - 24.6 mg, titanium dioxide - 25 mg, pregelatinized starch - 129.5 mg, sodium benzoate - 9.25 mg , banana flavor - 12.4 mg, raspberry flavor - 6.1 mg.

37 g - dark glass bottles with a capacity of 125 ml (1) complete with a measuring spoon - cardboard packs.

pharmachologic effect

Antiviral agent. Specifically suppresses in vitro influenza A and B viruses (Influenza virus A, B), including highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other viruses that cause ARVI (Coronavirus associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)). According to the mechanism of antiviral action, it belongs to fusion inhibitors (fusion), interacts with the hemagglutinin of the virus and prevents the fusion of the lipid membrane of the virus and cell membranes. It has interferon-inducing activity - in a study on mice, the induction of interferons was noted already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration.Stimulates cellular and humoral reactions of immunity: increases the number of lymphocytes in the blood, especially 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 killer cells (NK cells).

Therapeutic efficacy for viral infections is manifested in a decrease in the duration and severity of the course of the disease and its main symptoms, as well as in a decrease in 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 taken orally in recommended doses.

Pharmacokinetics

Absorption and distribution

It is quickly absorbed and distributed to organs and tissues.

Cmax in blood plasma when taking the drug at a dose of 200 mg of umifenovir is achieved after 1 hour, Vd - 1432 liters.

Metabolism and excretion

Metabolized in the liver.

T1 / 2 averages 11 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and, in small amounts, by the kidneys (0.12%).

During the first day, 90% of the administered dose is removed.

Indications for use

- 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 from 2 years of age

- 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 over 12 years of age and adults.

Contraindications for use

- hypersensitivity to umifenovir or any component of the drug

- age up to 2 years

- age up to 6 years (according to the indication, non-specific prophylaxis of SARS)

- age up to 12 years (according to indications for SARS treatment).

- sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Dosage regimen

Inside, before meals.

Suspension preparation

In the bottle containing the powder, add 30 ml (or

Name ENG

ARBIDOL

Clinical and pharmacological group

Antiviral drug

ATX code

Umifenovir

Dosage

5mg / ml x 37g

Structure

Composition for 5 ml: active substance: umifenovir (umifenovir hydrochloride monohydrate - 25.88 mg), (in terms of umifenovir hydrochloride - 25.00 mg)

excipients: sodium chloride - 26.85 mg, maltodextrin (Kleptose Linecaps) - 750.00 mg, sucrose (sugar) - 840.42 mg, colloidal silicon dioxide (Aerosil) - 24.60 mg, titanium dioxide - 25.00 mg, pregelatinized starch (type PA5PH) - 129.50 mg, sodium benzoate - 9.25 mg, banana flavor - 12.40 mg, cherry flavor - 6.10 mg.

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 from 2 years of age

non-specific 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 over 12 years of age and adults.

Storage conditions and periods

At a temperature not higher than 25 degrees

after cooking - in the refrigerator at a temperature not exceeding 8 degrees, do not freeze.

Expiration date: 2 years

after preparation - 10 days

INN / Active ingredient

umifenovir hydrochloride

Contraindications

Hypersensitivity to umifenovir or any component of the drug.

Age up to 2 years

age up to 6 years (according to the indication, non-specific prophylaxis of SARS)

age up to 12 years (according to indications for treatment of SARS).

Sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Specifications

Category

Antiviral

,

Antimicrobial agents

Scope of the medicinal product

The immune system

Release form

Oral suspension

Manufacturer country

Russia

Package quantity, pcs

one

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

OTCPharm

Components

measuring spoon

The amount of the dosage form in the primary package

37 g

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiviral agent

Anatomical and therapeutic characteristics

J05AX13 Umifenovir

Dosage form

Powder for preparation of suspension for oral administration

Expiration date in days

730

The target audience

Children

Dosage (volume) of the substance in the preparation

umifenovir hydrochloride monohydrate 25.88 mg

Package weight, g

150

Mode of application

:

Inside, before meals. < br> Preparation of suspension. < br> In a bottle containing powder, add 30 ml (or about 2/3 of the volume of the bottle) of boiled and cooled to room temperature water. Close the bottle with a lid, turn over and shake thoroughly until a homogeneous suspension is obtained. Add boiled and cooled water to a volume of 100 ml (up to the mark on the bottle) and shake again. Before each use, shake the contents of the vial thoroughly until a homogeneous suspension is obtained. Measure a single dose using the supplied measuring spoon. < br> Single dose (depending on age): < br> from 2 to 6 years old - 10 ml (50 mg) < br> from 6 to 12 years old - 20 ml (100 mg ) < br> over 12 years old and adults - 40 ml (200 mg) < br> For children from 2 years old and adults: < br> Non-specific prophylaxis during an epidemic of influenza and other acute respiratory viral infections - in a single dose 2 times a week for 3 weeks. < br> Non-specific prophylaxis in direct contact with patients with influenza and other acute respiratory viral infections - in a single dose once a day for 10-14 days . < br> 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. < br> In children from 2 years of age: < br> Complex therapy of acute intestinal infections of rotavirus etiology - in a single dose 4 times a day (every 6 hours) for 5 days. < br> For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS): < br> For non-specific prophylaxis of SARS (in contact with a sick person) in children with 6 years and adults: for children from 6 to 12 years old - 20 ml (100 mg),children over 12 years old and adults - 40 ml (200 mg) once a day for 12-14 days. < br> For the treatment of SARS in children from 12 years old and adults: < br> children over 12 years old and adults - 40 ml (200 mg) 2 times a day for 8-10 days.

Information on technical characteristics, delivery set, country of manufacture