The AEROLIGHT nebulizer system is a medical device used to produce an aerosol intended for inhalation. It is
for individual use.
a) Indications
The aerosol is a suspension of liquid and solid particles in a gas. Nebulisation is the creation of an aerosol from
a liquid preparation.
The AEROLIGHT nebulizer system is used to treat the following bronchopulmonary diseases:
Asthma
Cystic Fibrosis
Tracheitis
b) Contraindications and adverse effects
There are no contraindications linked to using the AEROLIGHT nebulizer system.
Adverse effects linked to nebulizers: A risk of allergy to the materials used (polypropylene, thermoplastic
elastomer) with parts of the body in contact with the mask or mouth piece is possible.
Adverse effects linked to drug products or solutions: Adverse effects linked to the use of some drug products
or some solutions may arise (i.e. coughs, irritation, throat pain, etc.). If this is the case, refer to the user
instructions for the drug product or solution and notify your doctor.
Adverse effects linked to the use of corticoids: It is preferable to use a mouth piece. Otherwise, if the mask is
used, we recommend that you wash your face and/or your mouth after the session. Refer to the leaflet for
the drug product.
a) Nebulizer system performance (EN 13544-1)
PERFORMANCE
PARTICLE-SIZE
DISTRIBUTION CURVE
Information relating to filling volumes, inhalable mass and flow rate of aerosol produced are shown on the
nebulizer's packaging.
b) Solutions that may be nebulized
We do not recommended nebulizing:
Oily solutions that may cause lipoid pneumonia;
Purified water and hypotonic formulations, including distilled water;
Formulations containing excipients or potentially dangerous preservatives;
Solutions not intended for this route of administration.
WARNING: Only nebulizable drug products or solutions that have been authorised for sale for this route of
administration ("nebulisation") may be used.
NOTE: Please read the leaflet for the drug product or nebulizable solution before use. Contact your doctor if
you have any questions.
1. Intended Use
Chronic Obstructive Pulmonary Disease (COPD)
Pneumocystis (Pneumocystis Jirovecii infection)
Pneumopathies
2.
DAMM
Aerosol therapy
EXTRANEB+ NEBULIZER WITH A PURENEB®
ALIGHT UNIT
4.2µm
Aerodynamic
diameter (µm)
15