MedPath logo

ANORO ELLIPTA INHALATION POWDER 62.5 MCG/25 MCG

Prescription Only
Drug type: Therapeutic
ATC code: R03AL03
Dosage form: POWDER, METERED
Route of administration: RESPIRATORY (INHALATION)
Active ingredient: (VI STRIP) VILANTEROL TRIFENATATE (MICRONISED) 40 mcg/dose EQV VILANTEROL; (UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 mcg/dose EQV UMECLIDINIUM; (UMEC STRIP) UMECLIDINIUM BROMIDE (MICRONISED) 74.2 MCG/DOSE EQV UMECLIDINIUM; (VI STRIP) VILANTEROL TRIFENATATE (MICRONISED) 40 MCG/DOSE EQV VILANTEROL

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.

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 Populationsplease 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 Populationsplease 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 Populationsplease refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Registrant
GLAXOSMITHKLINE PTE LTD
Approval Date
2015-08-28
Approval Number
SIN14838P
Manufacturer
GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS) GLAXOSMITHKLINE LLC
Licence Holder
GLAXOSMITHKLINE PTE LTD