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Matched label
Trelegy Ellipta
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE - GlaxoSmithKline LLC
is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 18 years and older.
Label facts
- Application
- NDA209482
- Route
- RESPIRATORY (INHALATION)
- Label updated
- June 2, 2023
Indication
is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 18 years and older.
Dose and administration
• For oral inhalation only. • Maintenance treatment of COPD: 1 actuation of TRELEGY ELLIPTA 100/62. 5/25 mcg once daily administered by oral inhalation.
Side effects
- upper respiratory tract infection
- pneumonia
- bronchitis
- oral candidiasis
- headache
- back pain
- arthralgia
- influenza
Safety flags
Three trials included adult and adolescent subjects aged 12 years and older
Contraindication: is contraindicated in the following conditions: • Primary treatment of status asthmaticus
Contraindication: other acute episodes of COPD
Contraindication: asthma where intensive measures are required .
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