Description
Sterile Class IIa Inhalable Medical Device.
3% hypertonic NaCl saline solution, pH-controlled and buffered with sodium bicarbonate. It is a sterile ready-to-use solution, indicated in aerosol therapy as an adjuvant in the treatment of respiratory diseases, including those of viral origin, with impaired mucociliary clearance.
RINOREX aerosol bicarbonate, a sterile hypertonic saline solution based on NaCl and NaHCO3, through an osmotic mechanism, restores the regular passage of water and electrolytes at the level of the respiratory epithelium, providing a greater state of hydration to the ASL ("Air Surface Liquid") and stimulating mucociliary clearance, as well as modifying the rheological characteristics of the mucus, making it more easily transportable.
RINOREX aerosol bicarbonate, thanks to the presence of sodium bicarbonate, performs a buffering function, correcting the pH of the respiratory mucosa of the lower airways.

Instructions for use
Use one 3 ml ampoule twice a day or as prescribed by a doctor. Where deemed appropriate, it is also possible to start with a lower volume and progressively increase.
Single-use vial; once opened, the residual content of the vial cannot be reused.
Carefully wash the nebulizer ampoule, strictly following the instructions of the manufacturer of the inhalatory device used.
Pour the content of the vial into the nebulizer ampoule and inhale calmly.
In aerosol therapy, RINOREX aerosol bicarbonate can be used alone or to dilute other drugs; in the latter case, strictly follow the instructions on the packaging of the drug to be diluted.
The 3% hypertonic saline solution with sodium bicarbonate may present physico-chemical incompatibility with drugs used in lower respiratory tract pathologies (e.g., sodium cromoglicate).

Components
Water, sodium chloride, sodium bicarbonate.

Warnings
Keep the product away from light and heat sources.
Do not use the product after the expiry date; the expiry date refers to the intact product, correctly stored.
Do not use the product if the packaging is not intact.
Keep out of reach and sight of children. Avoid contact with eyes. The product is for inhalation use only. The vial is not intended for oral use. The vial is single-dose and single-use, not resealable and not reusable once opened. Use by children must be supervised by an adult. Inhalation of 3% hypertonic saline solution in particularly sensitive patients could cause episodes of bronchospasm; in this case, stop the treatment and consult a doctor to institute appropriate supportive therapy (e.g., use of bronchodilators).
In some cases, nebulization may cause a slight and transient feeling of local irritation.
Adherence to the instructions in the package leaflet reduces the risk of undesirable effects.
Hypersensitivity to the components.
Use, especially if prolonged, may lead to sensitization phenomena; if this occurs, stop treatment and consult a doctor to institute appropriate therapy.
It is important to report any undesirable effects not described in this package leaflet to your doctor or pharmacist.

Storage
Store at a temperature between 5°C and 25°C.
Shelf life for intact packaging: 24 months.

Format
Pack containing 25 vials of 3 ml.

Code. FT/CE/14