Bioparox

General characteristics. Structure:

Aerosol for inhalations the dosed 1 cylinder
Active agent:  фузафунгин 50 mg
excipients: aromatic additive of 14868 — 180 mg; ethanol anhydrous — 200 mg, saccharin — 1,25 mg; isopropyl myristate — 85,32 mg; propellant — норфлуран (1,1,1,2-тетрафторэтан, HFA-134a) — 11386 mg  
composition of aromatic additive 14868 (180 mg): геранилацетат, isoamyl acetate, anisic alcohol, ethanol of 96%, фенилэтанол, methyl anthranilate, anisic oil, caraway seeds ordinary fruits extract, clove tree of kidneys extract, coriander of seeds extract, wormwood grass tarragon oil, mints field extract, orange of sweet of fruits of a peel extract; wild orange extract; pimento (allspice) of fruits extract, rosemary pharmaceutical flowers extract, ethylvanillin, geraniol, heliotropin, indole, linalol, isopropyl myristate  
1 dose makes 4 inhalations. 1 inhalation corresponds to 0,125 mg of a fuzafungin. One cylinder contains 400 inhalations  

Description of a dosage form

The aerosol aluminum can equipped with the valve of the dosing action.

Cylinder contents: solution of yellow color with a specific smell.

Pharmacological properties:

Pharmacological action - antibacterial, antiinflammatory local.

Pharmacokinetics. After use does not come to light in a blood plasma. After inhalation pharmacological active component of drug remains on a mucosal surface of a cover of respiratory tracts. At quadruple inhalation through a mouth or through each nasal course concentration of a fuzafunzhin at the level of lungs — 80 mkg/ml is reached; a trachea and bronchial tubes — 40 mkg/ml; a nasal cavity — 60 mkg/ml.

Pharmacodynamics. It is active concerning streptococci of group A, pneumococci, stafilokokk, some strains of neysseriya, a number of anaerobe bacterias, mycoplasmas, sort Candida mushrooms. Causes a stunt and development of microorganisms in concentration below, than 30 mkg/ml. Stability does not develop. The aerosol form provides penetration of drug into the most remote and hardly accessible departments of respiratory tracts (sine, bronchioles).

Indications to use:

Upper respiratory tract infections (sinusitis, rhinitis, a nasopharyngitis, pharyngitis, a state after a tonsilectomy, laryngitis, tracheitis, bronchitis).

Route of administration and doses:

For inhalations (through a mouth and/or a nose).

Adults: on 4 inhalations through a mouth and/or on 2 inhalations in each nasal course 4 times a day.

Children: on 2–4 inhalations through a mouth and/or on 1–2 inhalations in each nasal course 4 times a day.

For the maximum use of activity of the drug Bioparoks® it is important to observe the ordered dosage and to carry out rules of use of the enclosed nozzles. For ensuring lasting therapeutic effect it is necessary to observe duration of the ordered treatment: it is not recommended to stop treatment at emergence of the first signs of improvement since the premature termination of therapy can lead to a recurrence.

Drug should be had always at itself, having placed it in the enclosed case for portable carrying.

Duration of a usual course of treatment should not exceed 7 days.

Upon termination of a course of therapy it is necessary to see a doctor for assessment of efficiency of treatment.

At preservation of symptoms of a disease and/or the increased temperature against the background of therapy by the drug Bioparoks®neobkhodimo to report about it to the attending physician.

In case of existence of the expressed clinical displays of a bacterial infection performing treatment by the drug Bioparoks® in a combination with system antibiotics is possible.

Drug Bioparoks® route of administration

1. Before the first use for activation of a cylinder it is necessary to press its basis 4 times.
 
2. To put on the corresponding nozzle a cylinder: (white, for inhalation of drug through a mouth, or yellow (for adults) and transparent (for children), for its introduction through a nose).

Use of drug through a nose (at rhinitis, a nasopharyngitis, sinusitis):

The cylinder with drug needs to be held vertically a nozzle up, having clamped it between big and index fingers.

1. To clean a nose before drug use.

2. To fix a nozzle — yellow (for adults) or transparent (for children) — on a cylinder and to enter it into the nasal course (having clamped at the same time the opposite nasal course and having closed a mouth).
 
3. During a deep breath through a nose vigorously and against the stop to press the cylinder basis.

Use of drug through a mouth

at pharyngitis, tonsillitis, a state after removal of almonds, laryngitis
 
To put on a white nozzle a cylinder and to enter it into a mouth, having densely clamped lips.

 
It is strong and long to press a cylinder, taking a deep breath, for full irrigation of almonds and a throat;

at tracheitis

To clear the throat, then to deeply inhale aerosol mix and to hold the breath for several seconds for fuller irrigation of a trachea.

Nozzles for a mouth and a nose need to be disinfected every other day by means of the cotton plug moistened in 90% alcohol.

Features of use:

Duration of a usual course should not exceed more than 10 days. In need of carrying out longer course of therapy, it is necessary to revise its scheme. In case of existence at the sick expressed symptoms of intoxication or generalization of an infection, the combination with system antibiotics is necessary.

Side effects:

The following side effects were noted against the background of reception of a fuzafungin with the following frequency: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); seldom (≥1/10000, <1/1000); very seldom (<1/10000); unspecified frequency (frequency cannot be counted according to available data).

Allergic reactions are observed very seldom. Development of the local, quickly taking place reactions, mainly at the patients predisposed to an allergy is possible.

General frustration and symptoms: very often — sneezing, unpleasant taste in a mouth, reddening of a mucous membrane of eyes; often — dryness of mucous membranes of respiratory tracts, feeling of irritation in a throat, cough, nausea; unspecified frequency — vomiting.

Usually the treatment termination is not required.

From immune system: very seldom — an acute anaphylaxis.

From respiratory system: very seldom — asthmatic attacks, attacks of bronchial asthma, short wind, a laryngospasm, a Quincke's edema, including throat hypostasis.

From integuments: very seldom — rash, an itch, urticaria.

In case of development of allergic reactions administration of drug has to be stopped, it is not necessary to resume administration of drug.

Due to the risk of development of an acute anaphylaxis in case of emergence respiratory, including laryngeal or skin (an itch, a generalized erythema) symptoms immediate introduction of Epinephrinum (adrenaline) in oil of 0,01 mg/kg is recommended. If necessary it is necessary to carry out a repeated injection in oil in 15–20 min.

Interaction with other medicines:

Special researches on studying of interaction with other medicines were not conducted.

Contraindications:

Hypersensitivity to active agent or to the excipients which are a part of drug;

children's age up to 2,5 years (danger of development of a laryngospasm).

With care: at the patients predisposed to allergic reactions and a bronchospasm (see. "Side effects").

Use at pregnancy and feeding by a breast

Clinical data on use during pregnancy are absent. In this regard pregnant women should appoint drug with care.

In long researches on laboratory animals it is not revealed embrio-, genotoksichesky effects and teratogenic action on a fruit.

Due to the lack of data on excretion with breast milk purpose of the drug Bioparoks® is not recommended to the feeding women.

Overdose:

There is limited information on overdose of a fuzafungin.

Symptoms: blood circulation disturbance, numbness in a mouth, dizziness, strengthening of a pharyngalgia, burning in a throat.

Treatment: in case of overdose treatment has to be symptomatic, with the subsequent observation.

Storage conditions:

Period of validity 3 years. List B. At a temperature not above 30 °C.

Issue conditions:

According to the recipe

Packaging:

Aerosol for inhalations dosed 0,125 mg / inhalation.

10 ml of solution (400 inhalations) in an aerosol aluminum can. The cylinder has the valve of the dosing action supplied with three nozzles sprayers: for a nose (yellow — for adults and transparent — for children) and a mouth (white), a cap activator.

One cylinder with nozzles sprayers and a cap activator in a blister strip packaging with a case for portable carrying and the instruction on a medical use in a cardboard pack.