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INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE [SIN14853P]
Active ingredients: INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE
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Product Info
INCRUSE ELLIPTA INHALATION POWDER 62.5 MCG/DOSE
[SIN14853P]
Product information
Active Ingredient and Strength | UMECLIDINIUM BROMIDE 74.2 MCG (MICRONISED) EQV. UMECLIDINIUM - 62.5 MCG/DOSE |
Dosage Form | POWDER, METERED |
Manufacturer and Country | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOM |
Registration Number | SIN14853P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R03BB07 |
Indications
INCRUSE ELLIPTA is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).
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).
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).
