(**) NOTE 2: 50% by volume of atomized particles
from the ampoule is smaller than the Mass Median Aerodynamic Diameter
(MMAD). This value indicates the ability of the ampoule to produce small particles:
clinical studies have shown that the efficacy of the ampoule is measured by the
ability to nebulize the medicinal product into particles with a diameter of between
1 and 5 microns to allow maximum deposition on the lungs, thus increasing the
effectiveness of the treatment.
The specified MMAD values were detected with the Malvern Spraytec tool.
The diagrams provide in order the percentage of the volume of spray solution
transported by particles with a diameter of less than the corresponding value in
pm reported in abscissa.
7 - DISPOSAL OF ALVEA AMPOLLE
All parts must be disposed of in accordance with current regulations on plastic
containers. The table shows the plastics used. All materials used do not contain
phthalates and natural latex was not detected.
PART
Upper body (1)
Atomizer (2)
Lower body (3)
Lid (4)
Inhalation valve (5)
Exhalation valve (6)
Mouthpiece (7)
Adult mask (8)
Paediatric mask (9)
8 - OPERATING CONDITIONS
- temperature from +5°C to +40°C
- relative humidity from 15% to 93%
- atmospheric pressure from 700 hPa to 1060 hPa
9 - STORAGE CONDITIONS
- temperature from -25 °C to +50 °C
- relative humidity less than 93%
- atmospheric pressure from 700 hPa to 1060 hPa
ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH
MATERIAL
Polypropylene
Polypropylene
Polypropylene
Polypropylene
Silicone
Silicone
Polypropylene
Silicone
Silicone