The delivered dose is 2.5 microgram tiotropium and 2.5 microgram olodaterol per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate and 2.736 microgram olodaterol hydrochloride.
(INN = tiotropium bromide), (INN = olodaterol).
The delivered dose is the dose which is available for the patient after passing the mouthpiece.
Spiolto Respimat Inhalation Solution is composed of an aqueous, multidose solution of tiotropium bromide monohydrate and olodaterol hydrochloride for oral inhalation, delivered by a RESPIMAT inhaler, which provides an aerosolized mist of appropriate particle size for delivery to the lung. Each actuation delivers 2.5 μg of tiotropium and 2.5 μg of olodaterol from the mouthpiece. One dose consists of two actuations.
Spiolto Respimat Inhalation Solution is a clear, colourless solution of tiotropium bromide monohydrate and olodaterol hydrochloride contained in a cartridge. The solution is filled in a plastic container which is crimped into an aluminium cylinder to form the cartridge.
Excipients/Inactive Ingredients: Benzalkonium chloride, disodium edetate, water, purified, 1 M hydrochloric acid (for pH adjustment).