There is limited information about overdose of fusafungin.
Symptoms: circulatory disorders, numbness in the mouth, dizziness, increased pain in the throat, burning in the throat.
Treatment: in case of overdose, treatment should be symptomatic, followed by follow-up.
hypersensitivity to the active substance or to the excipients that are part of the drug,
patients predisposed to allergic reactions and bronchospasm (see " Side effects»),
children under 12 years of age (see "Side effects").
Special studies on the interaction with other drugs have not been conducted.
Aerosol aluminum cylinder, equipped with a metering valve.
The contents of the tank: the solution is yellow with a specific smell.
The following side effects have been observed with fusafungin with the following frequency: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000), unknown frequency (frequency cannot be calculated from available data).
Allergic reactions against the background of the use of fusafungin, they are very rare, but their development is possible, especially in patients prone to allergies. Severe allergic reactions have also been reported in children (see "Contraindications" and "Special instructions"). The most common reactions are observed at the site of application of the drug.
On the part of the immune system: very rarely-anaphylactic shock.
From the nervous system: very often — dysgeusia (violation of taste sensations).
On the part of the visual organs: very often — redness of the conjunctiva.
From the respiratory system, chest and mediastinal organs: very often-sneezing, often-dry nose, dry throat, throat irritation, cough, very rarely-attacks of bronchial asthma, bronchospasm, shortness of breath, laryngospasm, angioedema, including laryngeal edema.
From the gastrointestinal tract: often-nausea, unknown frequency-vomiting.
From the skin and subcutaneous tissues: very rarely-rash, itching, urticaria, Quincke's edema.
If any of the side effects described in the description are aggravated, or the patient has noticed any other side effects not specified in the description, you should inform your doctor.
Without a prescription.
Excessive prolonged use of the drug can lead to the development of superinfection. It is not recommended to exceed the duration of the standard 7-day course of therapy in accordance with the general rules for the use of antibiotics. At the end of the 7-day course of therapy, you should consult a doctor to assess the effectiveness of treatment. If the symptoms and clinical signs of the disease do not decrease during the 7 days of therapy, alternative treatment should be considered. Propylene glycol may cause skin irritation.
In case of allergic reactions, the drug should be discontinued, and the drug should not be resumed.
Due to the risk of anaphylactic shock, immediate intravenous administration of epinephrine (epinephrine) may be required in the event of respiratory, laryngial or cutaneous symptoms (pruritus, generalized erythema). The recommended dose is 0.01 mg / kg/m. If necessary, the IV 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 spray the drug in the eyes. To avoid storing the drug in the vicinity of strong sources of heat. Do not expose to temperatures above 50 °C.
Do not break the tightness of the cylinder body and burn it even after full use of the drug.
Influence on the ability to drive vehicles, mechanisms. Bioparox® it does not affect the ability to drive the car and the speed of mental and physical reactions.
Treatment of infectious and inflammatory diseases of the upper respiratory tract in adults and adolescents from 12 years of age:
rhinitis,
pharyngitis,
rhinopharyngitis,
laryngitis,
tonsillitis,
condition after tonsillectomy,
sinusitis.
Fusafungin is a topical antibiotic with anti-inflammatory properties.
In the conditions of 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) Streptococcus pneumoniae (Pneumococci), staphylococcus (Staphylococci), some strains of Neisseria (Neisseria), some anaerobes, fungi of the genus Candida (Candida albicans) and mycoplasma pneumoniae (Mycoplasma pneumoniae).
Fusafungin has a pronounced anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNF-α) and suppressing the synthesis of free radicals by macrophages while maintaining phagocytosis.
Fusafungin is mainly distributed in the oropharynx and nasal cavity. In the blood plasma, fusafungin can be detected in very low concentrations (no more than 1 ng / ml), which does not affect the safety of the drug.
No special storage conditions are required.
Keep out of reach of children.
Expiration date of the drug Bioparox®2 года.Do not use after the expiration date indicated on the package.
| Aerosol for topical use, metered | 1 cylinder/1 release |
| 1 cylinder/1 release containing 10 ml/0.025 ml of solution (0.59 ml/0.001475 ml of concentrate and 9.41 ml/0.023525 ml of propellant), contain: | |
| active substance: | |
| fusafungin | 50 mg/0.125 mg |
| excipients: aromatic additive 14868-180.00 mg / 0.45 mg, anhydrous ethanol-200.00 mg/0.5 mg, saccharin-1.25 mg/0.003125 mg, isopropyl myristate-85.32 mg/0.2133 mg, propellant-norflurane (1,1,1,2 - tetrafluoroethane, HFA-134a) — 11386.00 mg/28.465 mg | |
| composition of the aromatic additive 14868: geranyl acetate, isoamyl acetate, anise alcohol, 96% ethanol, phenylethanol, methylanthranilate, extract Badian (anise oil), extract Carvi (common cumin fruit extract), extract Cloves (clove tree kidney extract), Coriander Extract (Coriander seed extract), wormwood tarragon herb oil, extract China mint (mint field extract), extract Florida Valencia orange (sweet orange fruit peel extract), extract Paraguay small grain (orange extract), extract Peppercorn (pimenta (allspice) fruit extract), extract Rosemary (rosemary pharmacy flower extract), vanilla resinoid, propylene glycol, ethyl vanillin, lignin-based vanillin, geraniol, heliotropin, indole, linalol, terpineol, isopropyl myristate | |
| 1 dose is 4 releases. 1 release corresponds to 0.125 mg of fusafungin. 1 cylinder contains 400 releases |
Aerosol for topical use, dosed, 0.125 mg / release. 10 ml of the solution in an aerosol aluminum cylinder. 400 releases (100 doses) per aluminum cylinder. The balloon has a metering valve, equipped with two spray nozzles: for the nose (yellow) and mouth (white), an activator cap. One cylinder with spray nozzles and activator cap in a contour cell package with a case for portable carrying and instructions for medical use in a cardboard pack.
Clinical data on the use during pregnancy are not available. In this regard, prescribe the drug to pregnant women with caution.
In long-term studies on laboratory animals, no embryo -, genotoxic effects and teratogenic effects on the fetus were revealed.
Due to the lack of data on excretion in breast milk, the use of the drug Bioparox® it is not recommended for lactating women.
Topically (for release in the oral cavity and / or in the nasal passage).
Adults and children over 12 years of age: 4 releases in the oral cavity and/or 2 releases in each nasal passage 4 times a day.
To maximize the use of the activity of the drug Bioparox® it is important to observe the prescribed dose and follow the rules for using the attached attachments. For a lasting therapeutic effect, it is necessary to observe the duration of the prescribed treatment: it is not recommended to stop treatment when the first signs of improvement appear, since premature discontinuation of therapy can lead to a relapse.
The drug should always be carried with you, placing it in the attached portable carrying case.
The duration of the usual course 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 persist during therapy with Bioparox® you must inform your doctor about this.
In the case of severe clinical manifestations of bacterial infection, treatment with Bioparox is possible® in combination with systemic antibiotics.
Method of application of the drug Bioparox®
1. Press the base of the cylinder 4 times to activate it before using it for the first time.
2. Put the appropriate nozzle on the balloon: (white, for inhalation of the drug through the mouth (2) or yellow, for its administration through the nose) (Fig. 1).
Use of the drug through the nose (for rhinitis, rhinopharyngitis, sinusitis):
The balloon with the drug must be held vertically with the nozzle up, holding it between the thumb and index finger.
1. Clean your nose before using the drug.
2. Attach the yellow nozzle to the balloon and insert it into the nasal passage (while holding the opposite nasal passage and closing the mouth). When using, do not inhale.
3. Press the base of the cylinder twice vigorously and until it stops, holding the cylinder in a vertical position (Fig. 2).
Use of the drug through the mouth (for pharyngitis, tonsillitis, a condition after the removal of tonsils, laryngitis)
Put the white nozzle on the balloon (fig.3) and insert it into your mouth, holding it tightly between your lips. Hold the balloon as shown in Figure 4. Do not inhale when using.
Hold the balloon vertically and press the base of the balloon 4 times until it stops, as shown in Figure 4.
The mouth and nose tips should be disinfected every other day with a cotton swab soaked in 90% ethyl alcohol.
R02AB03 Fusafungin
