Posology : מינונים

4.2    Posology and method of administration

Posology
The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).

If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.

Special populations

Elderly
No dose adjustments are required in elderly patients (see section 5.2).
Renal impairment
This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. It can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).
Hepatic impairment
This medicinal product can be used at the recommended dose in patients with mild to moderate hepatic impairment. It can also be used at the recommended dose in patients with severe hepatic impairment, only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).

Paediatric population
Trixeo Aerosphere is not indicated in children and adolescents below 18 years of age for the indication of COPD.
Method of administration

For inhalation use.

Instructions for use
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique. The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.
Note: It is important to instruct the patients to:

•     Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet. For best results the inhaler should be at room temperature before use.
•     Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, after weekly washing or if it has been dropped.
•     Rinse their mouth out with water after inhaling the dose to minimise the risk of oropharyngeal thrush. Do not swallow.

On actuation of Trixeo Aerosphere, a volume of the suspension is expelled from the pressurised container. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.

Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. Trixeo Aerosphere can be used with spacer devices including the Aerochamber Plus Flow-Vu (see section 5.2).