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Dosage Regimen: General target population: Adults: 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.
Special populations: Renal impairment: No dosage adjustment is required for patients with renal impairment.
Hepatic impairment: No dosage adjustment is required for patients with mild and moderate hepatic impairment. No data are available for patients with severe hepatic impairment (see PHARMACOLOGY under Actions).
Pediatric patients (below 18 years): Onbrez Breezhaler should not be used in patients under 18 years of age.
Geriatric patients (65 years of age or above): No dosage regimen adjustment is required in patients 65 years of age or above.
Method of administration: Onbrez Breezhaler capsules must be administered only by the oral inhalation route and only using the Onbrez Breezhaler inhaler. Onbrez Breezhaler capsules must not be swallowed.
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.
Onbrez Breezhaler capsules must always be stored in the blister, and only be removed IMMEDIATELY BEFORE USE. Instructions on how to use the Onbrez Breezhaler inhaler are provided in INFORMATION FOR PATIENTS under Patient Counselling Information.
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.
