BIOPAROKS

Active material: fuzafungin
When ATH: R02AB03
CCF: Antibacterial drug for local use in ENT practice
ICD-10 codes (testimony): J00, J01, J02, J03, J04, J20, J31, J32, J35.0, J37, J42
At KFU: 06.15.02
Manufacturer: Servier Laboratories (France)

Pharmaceutical form, composition and packaging

Aerosol for inhalation dose as a solution of a yellow color and odor.

Excipients: aromaticheskaya supplement 14868, Anhydrous ethanol, saxarin, isopropylmyristate, propellant 1,1,1,2-tetrafluoroethane (HFA 134a).

10 ml (400 inhalations) – Aluminium aerosol containers with a metering valve action (1) complete with spray nozzles and cap-activator – packings Valium planimetric (1) with carrying case for portable – packs cardboard.

Pharmacological action

Antibiotics for topical use. It has antibacterial and anti-inflammatory activity.

Bioparoks^® – in the form of an aerosol microparticles, which penetrate into the most remote and inaccessible parts of the respiratory tract (sinusy, bronkhioly).

In vitro Bioparox^® active against: Streptococcus spp. Group A, Streptococcus pneumoniae (the old name – Pneumococcal), Staphylococcus spp., Some strains of Neisseria spp., Some anaerobes, as well as Mycoplasma spp., fungi of the genus Candida. Expected, fusafungine that has similar activity in vivo.

Pharmacokinetics

After inhalation of the drug Bioparox^® fusafungine mainly, distributed on the surface of the mucosa of the nasal cavity and oropharynx. Fusafungine can be detected in the blood plasma in very low concentrations (no more 1 ng / ml), that does not affect the safety of the drug.

Testimony

- Treatment of infectious and inflammatory diseases of the respiratory tract (rhinitis, rinofaringit, pharyngitis, laringit, tracheitis, tonsillitis, state after tonsillectomy, sinusitis, bronchitis).

Dosage regimen

The drug is used in the form of inhalations (through the mouth and / or nose).

Adults appoint 4 inhalation through the mouth and / or 2 inhalation in each nostril 4 times / day.

Children over 2.5 years appoint 2-4 inhalation through the mouth and / or 1- 2 inhalation in each nostril 4 times / day.

Duration of treatment, usually, less than 7 days.

Terms of use of the drug

Before using for the first cylinder press to activate its base 4 times.

At rynytah, rinofaringitax, sinusitax It should be inhaled through the nose. Before the inhalation nose should be cleaned. The container with the drug should be kept vertically packed up, holding it between thumb and forefinger. For inhalation through the nose to fix the nozzle on the tank (yellow for adults or for children transparent) and enter it into the nasal passage (while holding the opposite nostril and close the mouth). During a deep breath in through your nose and energetic all the way to press the base of the cylinder.

At faringitax, tonzillitax, states after tonsillectomy, laringitax It should be inhaled through the mouth. Wear a white tip on the bottle, enter it in the mouth, tightly clamped lips, wherein the holding cylinder vertically and slightly obliquely. Then thoroughly and long pressing on the bottom of the bottle, take a deep breath for a complete irrigation of the tonsils and pharynx.

At tracheitis, ʙronxitax inhaled through the mouth also conduct, as stated above. Before the necessary inhalation cough, then take a deep breath aerosol mixture and hold your breath for a few seconds to complete irrigation of the trachea and bronchi.

It should be disinfected daily tips with a cotton swab, moistened with ethanol (90°).

Side effect

Local reactions: may dry mucous membranes of the respiratory tract, tingling sensation of nasal mucosa, mouth and throat, chikhaniye. These reactions are fast, usually, discontinuation of treatment is not required.

In some cases, there is a local reaction of the skin and mucous membranes, manifested in the appearance of swelling or redness, bronchospasm attacks, especially in patients, allergy-prone.

Contraindications

- Children up to age 2.5 years (risk of laryngospasm);

- Hypersensitivity to the drug.

FROM caution should apply Bioparox^® patients, predisposed to allergic reactions.

Pregnancy and lactation

Clinical data on the use of the drug in pregnancy. Prescribed the drug during pregnancy with caution and only in those cases, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Unknown, whether it is allocated fusafungine breast milk in humans. Use of the drug in lactating women is not recommended.

Cautions

With prolonged use of the drug may develop superinfection.

After the end of the 7-day course of treatment, the patient should see a doctor to evaluate the effectiveness of therapy.

To maximize the activity Bioparox^® you must comply with the prescribed number of inhalations and implement rules for the use of two nozzles attached.

For proof of therapeutic effect is necessary to observe the length of the prescribed treatment: it is not recommended to stop the sessions at the first signs of improvement – this can lead to relapse.

If symptoms persist, disease and / or high temperature during therapy with the drug Bioparox^®, the patient should inform the doctor.

In the event of generalization of infection is necessary to provide the possibility of treatment with antibiotics for systemic use.

For regular sessions the patient must always have a bottle with you, putting it in a carrying case for portable.

Do not spray the drug in the eye.

Effects on ability to drive vehicles and management mechanisms

Bioparoks^® It does not affect the ability to drive and speed of psychomotor reactions.

Overdose

Symptoms of overdose are not described.

Drug Interactions

Data on drug interactions Bioparox^® with other drugs, incl. and other antibiotics has not.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. No special storage conditions requires. Shelf life – 2 year.

Avoid storing the drug near strong heat sources. Do not expose to temperatures exceeding 50 ° C.

Do not seal failure body spray and combustion, even after use of the drug.