Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Umeclidinium Bromide 74.2 mcg (micronised) eqv. Umeclidinium
GLAXOSMITHKLINE PTE LTD
R03BB07
POWDER, METERED
Umeclidinium Bromide 74.2 mcg (micronised) eqv. Umeclidinium 62.5 mcg/dose
RESPIRATORY (INHALATION)
Prescription Only
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
ACTIVE
2015-09-21
INCRUSE ELLIPTA UMECLIDINIUM QUALITATIVE AND QUANTITATIVE COMPOSITION A plastic Ellipta inhaler consists of a grey body, a light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant packet. The tray is sealed with a peelable foil lid. _INCRUSE ELLIPTA 62.5 micrograms: _ Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a pre-dispensed dose of 62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide). CLINICAL INFORMATION 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_). RENAL IMPAIRMENT No dosage adjustment is required in patients with renal impairment (see _Pharmacokinetics _ _—_ _ Special Patient Populations_). 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_). 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_). WARNINGS AND PRECAUTIONS _INCRUSE ELLIPTA_ should not be used in patients with asthma since it has not been Baca dokumen lengkap