Flu-Acyl Broncho

Description of the medical device: FLU-ACIL Broncho, sterile solution for nebulizer and instillations is a medical product based on 3% hypertonic saline and N-acetylcysteine.

FLU-ACIL Broncho, Sterile Solution for Nebulizer and Instillation thins thick viscous mucus due to the physical and mechanical effect of its components.

Sodium chloride. Sterile buffered hypertonic sodium chloride solution. Hypertonic saline solutions applied directly to the mucous membrane of the upper respiratory tract take water from the intracellular to the extracellular space by osmosis. This increases the percentage of water in the mucus lining the epithelium, thinning it and thus facilitating its removal. 

N-acetylcysteine. The acetylated version of the amino acid cysteine has a mucolytic effect in direct contact with mucus. This is due to the presence of sulfhydryl radicals in the molecule, which can destroy the disulfide bonds of acidic sputum mucopolysaccharides (which give mucus viscosity) by depolymerizing macromolecules. The product remains active in the presence of purulent sputum. It has an indirect antioxidant effect associated with an increase in the synthesis of the antioxidant compound glutathione, as well as a direct antioxidant effect, protecting respiratory epithelial cells from damage by free radicals.

Indications for use: FLU-ACIL Broncho, sterile solution for nebulizer and instillation is a medicinal product in single-use ampoules indicated for the treatment of respiratory diseases accompanied by hypersecretion of dense and viscous sputum: acute bronchitis, chronic bronchitis and its complications, pulmonary emphysema, cystic fibrosis, bronchiectasis, sinusitis, secretory otitis media.

• spraying through a nebulizer during inhalation to reach the bronchial mucosa;
• direct instillation into the ear and nasal rinsing;
• administration in small doses endobronchially through indwelling catheters, during bronchoscopy, etc;

Nebulizer administration of the aerosol:
- Adults: one ampoule per session 1-2 times a day for 5-10 days, 
- children over 2 years of age - 1 to 5 ml (ml) of the solution per session 1-2 times a day for 5-10 days.

The dose and frequency of sessions can be changed by the physician in a wide range depending on the clinical and therapeutic effect without the need to significantly differentiate the doses for adults or children.

Instillation, rinsing of ears and other cavities:
- ½ ampoule or 1 ampoule per session.

Endotracheal and bronchial instillations: 
1 ampoule for use, 1-2 times a day or as needed.

A doctor's consultation is recommended before use.

Hypersensitivity to the active ingredients of the product or any excipients, children under 2 years of age. Peptic ulcer of the stomach and duodenum in the acute stage, hemoptysis, pulmonary hemorrhage.

During pregnancy and lactation, the use of a sterile solution for nebulizer and instillation "Flu-Acyl broncho" is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child and under the direct supervision of a physician.

Overdose

Excessive doses of a sterile solution for a nebulizer and instillation "Flu-Acyl broncho" during inhalation and endotracheal-bronchial administration of the agent can lead to a volumetric and excessive secretion of liquid secretion, which in the case of patients with suppressed cough reflex and expectoration, may lead to the need for bronchoalveolar lavage (lavage).

1 ampoule 5 ml (ml) contains: active ingredients: N-acetylcysteine 300 mg (mg), sodium chloride 150 mg (mg); excipients: sodium hydroxide, sodium edetate, water for injection.

Special precautions

The use of FLU-ACIL Broncho, sterile nebulizer solution and instillations in children should be performed under adult supervision!

The last inhalation should be performed no later than 3-4 hours before bedtime (approximately before 18:00) to allow time to evacuate sputum before bedtime. To increase hydration and mucolytic effect, it is advisable to drink enough fluids.

When opening the ampoule of FLU-ACIL Broncho, sterile solution for nebulizer and instillations, a sulfuric odor is released, which does not affect the use of the medical device.

When stored in open ampoules or transferred to aerosol equipment, N-acetylcysteine solution may, in rare cases, acquire a slight pink color, which does not affect the efficacy and tolerability of the product.

Intake of N-acetylcysteine, mainly at the beginning of the treatment, may dilute bronchial secretions and increase their volume. If the patient is unable to cough up sputum effectively, postural drainage or bronchial aspiration should be performed to avoid sputum stasis. 

Patients with bronchial asthma should be monitored by a physician during therapy with FLU-ACIL Broncho, sterile nebulizer solution and instillations. In case of bronchospasm, N-acetylcysteine should be discontinued immediately and appropriate treatment should be initiated.

Store at a temperature not exceeding 25 ℃ out of the reach of children, protected from light and heat sources.

It is recommended to open the ampoule of the sterile solution for nebulizer and instillation "Flu-Acyl broncho" immediately before use, store the opened ampoules in the refrigerator and use within 24 hours. A solution mixed with other drugs should be used as soon as possible and should not be stored.

Blister containing 10 ampoules of 5 ml (ml) in a box.

Pharma Line S.r.l., Via Bertani 2, 20154 Milan, Italy.