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HSA Approval

INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE

SIN14853P

INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE

INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE

September 21, 2015

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

POWDER, METERED

**Dosage and Administration** Pharmaceutical form: Inhalation powder, pre-dispensed. _INCRUSE ELLIPTA_ is for oral inhalation only. _INCRUSE ELLIPTA_ should be administered once daily at the same time of the day each day. **Adults** The recommended dose is one inhalation of _INCRUSE ELLIPTA_ once daily. **Children** Use in patients less than 18 years of age is not relevant given the indication for this product. **Elderly** No dosage adjustment is required in patients over 65 years (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dosage adjustment is required in patients with renal impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No dosage adjustment is required in patients with mild or moderate hepatic impairment. _INCRUSE ELLIPTA_ has not been studied in patients with severe hepatic impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

RESPIRATORY (INHALATION)

Medical Information

**Indications** _INCRUSE ELLIPTA_ is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).

**Contraindications** _INCRUSE ELLIPTA_ is contraindicated in patients with severe milk-protein allergy. Hypersensitivity to the active substance(s) or to any of the excipients (see _List of Excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

R03BB07

umeclidinium bromide

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)

GlaxoSmithKline LLC

Active Ingredients

Umeclidinium Bromide 74.2 mcg (micronised) eqv. Umeclidinium

62.5 mcg/dose

Umeclidinium bromide

Documents

Package Inserts

Incruse Ellipta Inhalation Powder PI.pdf

Approved: May 9, 2023

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