Posology : מינונים

4.2     Posology and method of administration

Posology
The recommended dose is the inhalation of the content of one capsule once daily using the Seebri Breezhaler inhaler.

Seebri Breezhaler is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.


SEE API FEB22 V2                                                                 REF EU SmPC Nov2021 Special populations

Elderly population
Seebri Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).

Renal impairment
Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).

Hepatic impairment
No studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment.

Paediatric population
There is no relevant use of Seebri Breezhaler in the paediatric population (under 18 years) in the indication COPD.


Method of administration
For inhalation use only.
The capsules must be administered only using the Seebri Breezhaler inhaler (see section 6.6).
The capsules must only be removed from the blister immediately before use.
The capsules must not be swallowed.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.

For instructions on use of the medicinal product before administration, see section 6.6.