ARVIS Broncho solution for oral administration and inhalation 7.5mg / ml vial. 100ml

Dosage form

Transparent from colorless to brownish solution with a weak characteristic odor.

Release form

Solution for oral administration and inhalation 7.5 mg / ml - 100 ml in bottles, sealed with dropper stoppers.

Each bottle, together with instructions for use, is placed in a cardboard box.

Structure

1 ml of solution contains

Active ingredient: ambroxol hydrochloride - 7,500 mg

Excipients: sodium chloride - 6,220 mg

sodium hydrogen phosphate dihydrate - 4,350 mg

citric acid monohydrate - 2,000 mg

benzalkonium chloride - 0.225 mg

purified water - 989.705 mg

pharmachologic effect

Ambroxol is an active N-demethylated metabolite of bromhexine. It has a secretomotor, secretolytic and expectorant effect. Stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surfactant that ensures the sliding of bronchial secretions in the airway lumen. Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and helping to reduce the viscosity and thinning of sputum resulting in improved mucociliary transport (mucociliary clearance). Enhancing mucociliary clearance improves mucus excretion from the bronchial tree and relieves coughing.

On average, when taken orally, the effect of the drug occurs after 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Pharmacokinetics

After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration (Cmax) in the blood plasma after oral administration is reached after 1-3 hours. The volume of distribution is 552 liters. In the therapeutic range of concentrations, plasma protein binding is 80-90%. The highest concentrations of the active ingredient of the drug are observed in the lungs. Ambroxol crosses the placental and blood-brain barriers, is excreted in breast milk. Approximately 30% of the taken oral dose undergoes the effect of the primary passage through the liver. Studies on human liver microsomes have shown that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid.The rest of ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. The terminal half-life (T1 / 2) of ambroxol from blood plasma is 10 hours. The total half-life of ambroxol and its metabolites is about 22 hours. Excreted by the kidneys: 90% as metabolites, 10% unchanged.

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select a dosage for these signs.

Side effects

Possible side effects are listed in the following gradation: very often (> 1/10), often (> 1/100 to < 1/10), infrequently (> 1/1000 to < 1/100), rarely (> 1/10000 to < 1/1000), very rare (< 1/10000), unknown (cannot be estimated from the available data).

Violation of the gastrointestinal tract:

Often - nausea, decreased sensitivity in the mouth or pharynx

Uncommon - dyspepsia, vomiting, diarrhea, abdominal pain

Rarely - dryness of the oral mucosa and pharynx

Unknown - heartburn, constipation.

Respiratory system disorders:

Rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea.

Nervous system disorders:

Often - dysgeusia (violation of taste).

Immune system disorders:

Rarely - hypersensitivity reactions, skin rash, urticaria, itching, angioedema

In isolated cases - anaphylactic reactions, including anaphylactic shock.

Violations by ko

Name ENG

ORVIS BRONCHO

Clinical and pharmacological group

Mucolytic and expectorant drug

ATX code

ambroxol

Dosage

7.5mg / ml x 100ml

Structure

1 ml of solution contains.

Active ingredient: ambroxol hydrochloride - 7,500 mg.

Excipients: sodium chloride - 6,220 mg

sodium hydrogen phosphate dihydrate - 4,350 mg

citric acid monohydrate - 2,000 mg

benzalkonium chloride - 0.225 mg

purified water - 989.705 mg

Indications

ARVIS Broncho is used in the treatment of acute and chronic diseases with the release of viscous sputum:

acute and chronic bronchitis,

pneumonia,

chronic obstructive pulmonary disease,

bronchial asthma with difficulty in sputum discharge,

bronchiectasis.

Contraindications

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), breastfeeding period.

Carefully

Renal impairment and / or severe hepatic impairment

peptic ulcer of the stomach and duodenum during an exacerbation

pregnancy

(II-III trimester)

impaired bronchial motility and an increase in mucus secretion (with immobile cilia syndrome).

INN / Active ingredient

ambroxol

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Specifications

Category

Thinning phlegm

,

Expectorants

Scope of the drug

Ear, Throat, Nose

Release form

Solution

Manufacturer country

Russia

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

2 years old

Way of introduction

Through the respiratory tract

,

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

100 ml

Brand name

Evalar

Components

measuring glass

The amount of the dosage form in the primary package

100 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Expectorant mucolytic agent

Anatomical and therapeutic characteristics

R05CB06 Ambroxol

Dosage form

Solution for oral administration and inhalation

The target audience

Children

Dosage (volume) of the substance in the preparation

ambroxol 7.5 mg

Expiration date in days

1095

Package weight, g

150

Mode of application

:

Ingestion (1 ml = 25 drops) < br> Adults and children over 12 years old: the first 2-3 days, 4 ml (100 drops) 3 times a day (which corresponds to 90 mg of Ambroxol per day), then 4 ml 2 once a day (which corresponds to 60 mg of ambroxol per day). < br> Children from 6 to 12 years old: 2 ml (50 drops) 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day). < br> Children from 2 to 6 years old: 1 ml (25 drops) 3 times a day (which corresponds to 22.5 mg of ambroxol per day). < br> Children under 2 years old: 1 ml (25 drops) 2 times a day (which corresponds to 15 mg of ambroxol per day). < br> For children under 2 years of age, the drug is prescribed only under medical supervision. < br> The maximum daily dose for oral administration: for adults - 90 mg, for children 6-12 years old - 45 mg, for children 2-6 years old - 22.5 mg, for children under 2 years old - 15 mg. < br> The drug is used after meals, adding to water, tea, milk or fruit juice. < br> During treatment, it is necessary to consume a lot of liquid (water, tea, juice) to enhance the mucolytic effect of the drug. < br> < br> Inhalations < br> Adults and children over 6 years old: 1-2 inhalations of 2-3 ml (50-75 drops) of solution per day (which corresponds to 15-45 mg of ambroxol per day). < br> Children under 6 years old: 1-2 inhalations of 2 ml (50 drops) of solution per day (which corresponds to 15-30 mg of ambroxol per day). < br> The drug can be used using any modern equipment for inhalation (except for steam inhalers). To achieve optimal moisture during inhalation, the drug is mixed with 0.9% sodium chloride solution in a 1: 1 ratio. Since inhalation therapy can cause a deep cough to take place,inhalation should be carried out in normal breathing mode. It is usually recommended to warm the inhalation solution to body temperature before inhalation. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators, in order to avoid nonspecific irritation of the respiratory tract and their spasm. < br> If the symptoms of the disease persist within 4-5 days from the beginning of the intake, it is recommended to consult a doctor.If the symptoms of the disease persist within 4-5 days from the start of admission, it is recommended to consult a doctor.If the symptoms of the disease persist within 4-5 days from the start of admission, it is recommended to consult a doctor.

Information on technical characteristics, delivery set, country of manufacture