Posology : מינונים

4.2 Posology and method of administration
Posology
The recommended dosage of Onbrez Breezhaler is the once-daily inhalation of the content of
one 150 microgram capsule using the Onbrez Breezhaler inhaler. The dosage should only be
increased on medical advice.
Once-daily inhalation of the content of one 300 microgram capsule, using the Onbrez
Breezhaler inhaler, has been shown to provide additional clinical benefit to some patients, e.g.
with regard to breathlessness, particularly for patients with severe COPD. The maximum dose
is 300 microgram once-daily.
Onbrez Breezhaler should be administered at the same time of the day each day.
If a dose is missed, the next dose should be taken at the usual time the next day.

Special populations

Elderly population
No dose adjustment is required in elderly patients.

Hepatic impairment
No dose adjustment is required for patients with mild and moderate hepatic impairment.
There are no data available for use of Onbrez Breezhaler in patients with severe hepatic
impairment.

Renal impairment
No dose adjustment is required for patients with renal impairment.

Paediatric population
Onbrez Breezhaler should not be used in patients under 18 years of age.

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




ONB API JUN21 V1.1                                                    Ref EMA SmPC 15Dec2020