Bioparox - instructions for use, dose, side effects, contraindications

Active substanceFusafunginFusafungin

Similar drugsTo uncover

Bioparox®

aerosol locally

Servier Laboratories France

Dosage form: & nbspaerosol for topical use

Composition:

One cylinder containing 10 ml of solution (0.59 ml of concentrate and 9.41 ml of propellant) contains:

Active substance: fusafungin 50 mg.

Excipients: aromatic additive 14868 180.00 mg, ethanol anhydrous 200.00 mg. saccharin 1.25 mg. isopropyl myristate 85.32 mg, propellenetrflurane (1,1,1,2-tetrafluoroethane, HFA-134a) 11386.00 mg.

Composition per 1 release:

One release containing 0.025 ml of a solution (0.001475 ml of a concentrate and 0.023525 ml of a propellant) contains:

Active substance: fusafungin 0.125 mg.

Excipients: aromatic additive 14868 0.45 mg, anhydrous anhydrous 0.5 mg, saccharin 0.003125 mg. isopropyl myristate 0.2133 mg, propellennetrflurane (1,1,1,2-tetrafluoroethane, HFA-134a) 28.465 mg.

Composition of aromatic additive 14868:

geranilacetate, isoamyl acetate, anisic alcohol, ethanol 96%, phenylethanol, methylanthranilate, extract Badian (anise oil), extract Carvi (caraway seeds of ordinary fruit extract), extract Cloves (clove bud kidney extract), extract Coriander (coriander seed extract), wormwood tarragon herb oil, extract China mint (mint field extract), extract Florida lalencia orange (sweet fruit orange peel), extract Paraguay small grain (orange extract), extract Peppercorn (pimento (pepper fragrant) fruit extract), extract Rosemary (rosemary pharmacy flowers extract), vanilla rubber, propylene glycol. ethyl vanillin, lignin-based vanillin, geraniol, heliotropin, indole, linalol, terpineol, isopropyl myristate.

One dose is 4 releases. One release corresponds to 0.125 mg fusafungia. One bottle contains 400 releases.

Description:Aerosol aluminum canister, equipped with a dosing valve.

Contents: The container contains a yellow solution with a specific odor.

Pharmacotherapeutic group:Antibiotic polypeptide

ATX: & nbsp

R.02.A.B.03 Fusafungin

Pharmacodynamics:

Fusafungin is a topical antibiotic with anti-inflammatory properties.

In conditions in vitro the drug has an antimicrobial effect on the following microorganisms, which suggests a similar effect in vivo: group A streptococcus (group A Streptococci), Pneumococcus (Pneumococci), staphylococcus aureus (Staphylococci), some strains of Neisseria (Neisseria), some anaerobes, fungi; kind of candidate (Candida albicans) and mycoplasma pneumonia (Mycoplasma pneumoniae).

Fusafungin has a pronounced anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNF-a) and suppression of the synthesis of free radicals by macrophages while maintaining phagocytosis.

Pharmacokinetics:

Fusafungin, is mainly distributed in the oropharynx and nasal cavity. In the blood plasma fusafungin can be detected in a very low concentration (not more than 1 ng / ml), which does not affect the safety of the drug.

Indications:

Treatment of infectious and inflammatory diseases of the upper respiratory tract (rhinitis, pharyngitis, rhinopharyngitis, laryngitis, tonsillitis, condition after toizillectomy, sinusitis).

Bioparox is indicated for use in adults and adolescents with 12 years of age.

Contraindications:

Hypersensitivity to the active substance or to the excipients included in the preparation listed in section "Composition".
Children under the age of 12 years (see section "Side effect").
Patients who are predisposed to allergic reactions and bronchospasm (see section "Side effect").

Carefully:

BIOPAROX® should be used with caution in patients prone to allergic reactions.

Pregnancy and lactation:

Clinical data on the use during pregnancy are absent. In connection with this, prescribe the drug to pregnant women with caution.

In long-term studies on laboratory animals, embryo, genotoxic effects and teratogenic effects on the fetus were not detected.

Due to the lack of data on excretion in breast milk, the use of preparation BIOPAROX® lactating women are not recommended.

Dosing and Administration:

Locally (for release in the oral cavity and / or in the nasal passage).

Adults and children over 12 years: 4 releases per oral cavity and / or 2 releases per each nasal passage 4 times a day.

To maximize the use of BIOPAROX®, it is important to follow the prescribed dose and follow the rules for using attached attachments. To adhere to a stable therapeutic effect, the duration of the prescribed treatment should be observed: it is not recommended to discontinue treatment with the appearance of the first signs of improvement, as premature termination of therapy can lead to a relapse.

The drug should always be at hand, placing it in the attached case for portable carrying.

The duration of treatment should not exceed 7 days.

At the end of the course of therapy, you should consult a doctor to assess the effectiveness of treatment.

If the symptoms of the disease and / or fever are retained during the treatment with BIOPAROX®, it is necessary to inform the attending physician about it.

If there are significant clinical manifestations of bacterial infection it is possible to carry out drug treatment BIOPAROX® in combination with systemic antibiotics.

Method of application of BIOPAROX®

Before the first use of the balloon for activation, press the base 4 times.

Wear a suitable nozzle (white, for administration of the drug through the mouth or yellow, for its introduction through the nose (Figure I).

Use of the drug through the nose:

Rhinitis, rhinopharyngitis, sinusitis

The balloon with the drug must be kept vertically with the nozzle upward, holding it between the thumb and forefinger.

Clean your nose before using the drug.
Fix the yellow nozzle on the balloon and insert it into the nasal passage (while holding the opposite nasal passage and closing his mouth). When using, do not follow the "breath".
Vigorously and until it stops, press the base of the cylinder two times, holding the cylinder upright (Figure 2).

Use of the drug through the mouth:

Pharyngitis, tonsillitis, condition after removal of the tonsils, laryngitis

Wear a white nozzle on the bottle (Fig. 3) and put it in your mouth, tightly holding your lips.

When using, do not follow the inhale.

Keep the cylinder upright and energyTo the end, press four times on the base of the container as indicated on the Fig. 4.

Nozzles for the mouth and nose should be disinfected every other day with a cotton swab dipped in 90% ethyl alcohol.

Side effects:

The following side effects were noted with fusafungin at the following frequency: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, < 1/1000), rarely (< 1/10000) and an unknown frequency (the frequency can not be calculated from the available data).

Allergic reactions against the background of fusafungin are very rare, but their development is possible, in features in patients prone to allergies. Severe allergic reactions have also been noted in children (See Sections "Against the evidence" and "Special instructions").

The most frequently observed reactions in place of application.

Immune system disorders:

Rarely: anaphylactic shock.

Impaired nervous system:

Often: dysgeusia (a violation of taste sensations).

Violations from friction bodies:

Often: congestion hyperemia.

Disturbances from the respiratory system, chest and mediastinal organs:

Often: sneeze.

Often: dryness in the nose, dryness in the throat, irritation of the throat, cough.

Rarely: attacks of bronchial asthma, bronchospasm, dyspnea, laryngosnasm, angioedema, including laryngeal edema.

Disorders from the gastrointestinal tract:

Often: nausea.

Unidentified frequency: vomiting.

Disturbances from the skin and Pof dermal tissues:

Rarely: rash, itching, hives, Quincke's edema.

If any of the instructions for side effects are aggravated, or you notice any other side effects, not refer to the instructions of the doctor.

Overdose:

There is limited information about an overdose of fusafungin.

Symptoms: a violation of blood circulation, numbness in the mouth, dizziness, increased pain in the throat,burning in the throat. In case of an overdose, treatment should be symptomatic with follow-up.

Interaction:

Special studies on interactions with other drugs have not been conducted.

Special instructions:

Excessive use of the drug may lead to the development of superinfection. It is not recommended to exceed the duration of a standard 7-day course of therapy in accordance with general rules of use antibiotics. At the end of the 7-day course of therapy should refer to a doctor to assess the effectiveness of treatment.

If symptoms and clinical signs of the disease do not decrease for 7 days of therapy, should consider alternative treatment.

Propylene glycol can cause skin irritation.

In the case of allergic reactions, taking the drug should be stopped, do not resume taking the drug.

In connection with the risk of anaphylactic shock, if there are respiratory, laryngeal or skin symptoms (itching, generalized erythema), an immediate intramuscular injection of epinephrine (epinephrine) may be required.The recommended dose is 0.01 μ / kg intramuscularly. If necessary, intramuscular the injection can be repeated after 15-20 minutes.

The composition of the drug includes a small amount of ethanol, less than 100 mg / dose.

Do not spraypeer in the eyes.

Do not store the product near strong sources of heat.

Do not expose to temperature above 50 degrees. FROM.

Do not allow leakage of the cylinder housing and its burning even after full use of the preparation.

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

Bioparox does not affect the ability to drive a car and the speed of mental and physical reactions.

Form release / dosage:Aerosol for topical use dosed, 0.125 mg / release.

Packaging:

10 ml of solution in an aerosol aluminum can. For 400 releases (100 doses) in an aluminum can.

The balloon has a dispensing valve, equipped with two spray nozzles: for the nose (yellow) and the mouth (white), the capping activator.

One balloon with spray nozzles and an activator cap in a contour acheive box with a case for portable carrying and instructions for medical use in cardboardpack.

Storage conditions:

Special storage conditions are not required.

Keep out of the reach of children.

Shelf life:

2 years.

DO NOT USE AT THE EXPIRY OF THE YEAR OF LIFE, INDICATED ON PACKAGING.

Terms of leave from pharmacies:Without recipe

Registration number:P N 015629/01

Date of registration:16.07.2009

Date of cancellation:2016-05-17

The owner of the registration certificate:Servier LaboratoriesServier Laboratories France

Manufacturer: & nbsp