Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
POWDER, METERED
**Dosage and Administration** Pharmaceutical form: Inhalation powder, pre-dispensed _ANORO ELLIPTA_ is for oral inhalation only. _ANORO ELLIPTA_ should be administered once daily at the same time each day. **Adults** The recommended and maximum dose is one inhalation of _ANORO ELLIPTA_ 62.5/25 micrograms 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. _ANORO 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** _ANORO ELLIPTA_ is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).
**Contraindications** _ANORO ELLIPTA_ is contraindicated in patients with severe milk-protein allergy, or who have demonstrated hypersensitivity to either umeclidinium, vilanterol or any of the excipients in this product.
R03AL03
vilanterol and umeclidinium bromide
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)
GLAXOSMITHKLINE LLC
Active Ingredients
(UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 mcg/dose EQV UMECLIDINIUM
62.5 mcg/dose
Documents
Package Inserts
ANORO ELLIPTA INHALATION POWDER PI.pdf
Approved: February 24, 2023