Flu-Acyl Broncho

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.

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.

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.

• 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).

Known side effects

The use of FLU-ACYL Broncho, sterile nebulizer solution and instillations may cause occasional localized irritation that may cause bronchospasm, burning sensation in the nasal mucosa, rhinorrhea, nausea, vomiting.

The use of FLU-ACYL 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-ACYL 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-ACYL Broncho, sterile nebulizer solution and instillations. In case of bronchospasm, N-acetylcysteine should be discontinued immediately and appropriate treatment should be initiated.

Interaction with other products and other types of interaction

Patients receiving nitroglycerin-based medications should consult a physician before using the sterile solution for nebulizer and instillations “FLU-ACYL Broncho”, as the presence of N-acetylcysteine can lead to hypotension with dilation of the temporal artery. If concomitant use of nitroglycerin and N-acetylcysteine is necessary, the patient should be under medical supervision for the development of hypotension. The patient should be warned about the possibility of headache, in which case blood pressure should be monitored.

N-acetylcysteine should not be administered concomitantly with antitussives, as suppression of the cough reflex may increase bronchial secretion stasis.

Sterile solution for nebulizer and instillations “FLU-ACYL Broncho” can be used simultaneously with conventional bronchodilators, vasoconstrictors, etc., but should be used for the shortest possible time.

It is not recommended to mix antibiotics with the sterile solution for nebulizer and instillation “FLU-ACYL Broncho”.

Laboratory parameters

The use of N-acetylcysteine contained in the sterile solution for nebulizer and instillation “FLU-ACIL Broncho” may affect the results of the quantitative determination of salicylates by the colorimetric method and the results of the determination of ketones in the urine. It is recommended that you inform your doctor before using FLU-ACIL Broncho Sterile Nebulizing Solution and Instillation if you have recently taken any other medications, including medications obtained without a prescription.

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; phone: +390376329660