Bioparox (Fusafungine) 0.125mg 10ml spray

The drug forms

Aerosol aluminum balloon, equipped with a metering valve actions.

The contents of the container: a yellow solution with a specific smell.

pharmachologic effect

Mode of action – local anti-inflammatory.

pharmacodynamics

Fusafungine antibiotic is a topical anti-inflammatory properties.

In in vitro conditions the drug has an antimicrobial effect on the following micro-organisms, suggesting that a similar effect in vivo: group A streptococcus (group A Streptococci), Streptococcus pneumoniae (Pneumococci), Staphylococcus aureus (Staphylococci), some strains of Neisseria (Neisseria), some anaerobic bacteria, fungi genus candida (candida albicans) and mycoplasma pneumoniae (mycoplasma pneumoniae).

Fusafungine has marked anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNF-?) and the suppression of the synthesis of free radicals, while maintaining phagocytosis by macrophages.

Pharmacokinetics

Fusafungine mainly distributed in the oropharynx and nasal cavity. Fusafungine The plasma can be detected in very low concentrations (less than 1 ng / ml) did not affect the safety of the drug.

Indications Bioparox ® drug

Treatment of infectious and inflammatory diseases of the upper respiratory tract in adults and adolescents from 12 years:

• rhinitis;
• pharyngitis;
• nasopharyngitis;
• laryngitis;
• tonsillitis;
• state after tonsillectomy;
• sinusitis.

Contraindications

Hypersensitivity to the active substance or excipients included in the composition of the drug;

Patients predisposed to allergic reactions and bronchospasm (see “Side Effects.”);

Children under 12 years of age (see. “Side effects”).

Pregnancy and breast-feeding

Clinical data on the use during pregnancy are not available. In this regard, prescribe a drug to pregnant women with caution.

The long-term studies in laboratory animals have not revealed embryos, genotoxic effects and teratogenic effects on the fetus.

In the absence of data on excretion in breast milk drug application Bioparox® lactating women is not recommended.

Side effects

The following side effects have been observed in patients receiving fusafungine with the following frequency: very common (?1 / 10); commonly (?1 / 100, <1/10); uncommon (?1 / 1000, <1/100); rare (?1 / 10,000, <1/1000); very rare (<1/10000); unknown frequency (frequency can not be calculated from the available data).

Allergic reactions during treatment with fusafungine are very rare, but their development is possible, especially in patients who are prone to allergies. Severe allergic reactions have also been observed in children (see. “Contraindications” and “Special Instructions”). The most frequently observed in the reaction site of the drug.

Immune system: very rarely – anaphylactic shock.

From the nervous system: very often – dysgeusia (taste disturbance).

From the side of view: very often – conjunctival hyperemia.

The respiratory system, organs, thoracic and mediastinal disorders: very often – a sneeze; often – dry nose, dry throat, throat irritation, cough; very rarely – bronchial asthma, bronchospasm, dyspnea, laryngospasm, angioedema, including laryngeal edema.

On the part of the digestive tract: often – nausea; unknown frequency – vomiting.

Skin and subcutaneous tissue disorders: very rare – rash, itching, hives, angioedema.

If any of the above in the description of the side effects are compounded, or the patient has noticed any other side effects not mentioned in the description, you should inform your doctor.

Interaction

Special studies on the interaction with other drugs have not been conducted.

Dosing and Administration

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

Adults and children over 12 years: 4 release in the oral cavity and / or the release of 2 in each nostril 4 times a day.

To maximize the activity Bioparox® preparation is important to follow the prescribed dose and follow the rules of use of the accompanying attachments. For proof of the therapeutic effect of the duration of the prescribed treatment must be: do not stop treatment at the first signs of improvement since premature termination of therapy may lead to relapse.

The drug should always carry with them, placing it in the enclosed carrying case for portable.

Duration usual course of treatment should not exceed 7 days.

Upon completion of a course of therapy should consult a doctor to assess the effectiveness of treatment.

When you save the symptoms and / or elevated temperature on background therapy with Bioparox® must inform your doctor.

In the case of pronounced clinical manifestations of bacterial infection may be treated with medication Bioparox® in combination with systemic antibiotics.

Dosing Bioparox® drug

1. Before the first use to activate the cylinder press at its base 4 times.

2. Attach the nozzle to the tank proper (white, for inhalation of the drug through the mouth (2), or yellow, for its administration through the nose) (Figure 1.).

Use of the drug through the nose (rhinitis, nasopharyngitis, sinusitis)

The container with the drug should be kept vertically packed up, holding it between thumb and forefinger.

1. Clean your nose before using the drug.

2. Attach a yellow nozzle on the tank and put it into the nasal passage (while holding the opposite nostril and mouth closed). When using do not inhale.

3. Vigorously and push until it stops at the base twice balloon, holding the container in a vertical position (Fig. 2).

Use of the drug by mouth (for pharyngitis, tonsillitis, state after tonsillectomy, laryngitis)

To put on a white balloon nozzle (Figure 3) and put it in his mouth, his lips tightly clamped. Hold the balloon as shown in Figure 4. When using do not inhale.

Hold bottle vertically and vigorously all the way to click 4 times on the basis of the cylinder, as shown in Fig. 4.

Nozzles for the mouth and nose should be disinfected a day with a cotton swab dipped in 90% ethanol.

Overdose

There is limited information on overdose fusafungine.

Symptoms: poor circulation, numbness of the mouth, dizziness, increased pain in the throat, a burning sensation in the throat.

Treatment: In case of overdose symptomatic treatment should be followed by supervision.

special instructions

Excessive prolonged use of the drug may lead to the development of superinfection. Not recommended duration exceeding the standard 7-day course of treatment in accordance with the general rules of antibiotic. After a 7-day course of therapy should consult a doctor to assess the effectiveness of treatment. If the symptoms and clinical signs of the disease does not decrease during the 7 days of treatment, you should consider alternative treatments. Propylene glycol may cause skin irritation.

In case of allergic reactions the drug should be discontinued, should not reopen the drug.

Due to the risk of anaphylactic shock in case of respiratory, or skin laringialnyh symptoms (itching, generalized erythema) symptoms may require immediate / m administration of epinephrine (adrenaline). Recommended dosage is 0.01 mg / kg / m. If necessary, a / m injection can be repeated after 15-20 minutes.

The product contains a small amount of ethanol, less than 100 mg / dose. Do not spray the drug in the eye. Avoid storing product near strong heat sources. Do not expose to temperatures exceeding 50 ° C.

Do not allow violations of the liner tightness and burning it, even after the full use of the drug.

Effects on ability to drive vehicles, machinery. Bioparox® not affect the ability to control the car and the speed of mental and physical reactions.

release Form

Spray for topical metered dose, 0,125 mg / release. 10 ml of solution in aluminum aerosol bottle. Releases of 400 (100 doses) into the aluminum cylinder. The container has a valve dispensing action, equipped with two nozzles spray: Nasal (yellow) and mouth (white) cap-activator. One cylinder with nozzles, spray and cap-activator in blisters with a case for portable carrying and instruction for medical use in a carton box.