País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
olodaterol hydrochloride, Quantity: 2.736 microgram/actuation (Equivalent: olodaterol, Qty 2.5 microgram/actuation); tiotropium bromide monohydrate, Quantity: 3.124 microgram/actuation (Equivalent: tiotropium, Qty 2.5 microgram/actuation)
Boehringer Ingelheim Pty Ltd
Inhalation, conventional
Excipient Ingredients: purified water; benzalkonium chloride; hydrochloric acid; disodium edetate
Inhalation
3 x 1 cartridge (60 metered actuations) with dose indicator, 1 cartridge (60 metered actuations) with dose indicator
(S4) Prescription Only Medicine
SPIOLTO RESPIMAT is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Visual Identification: Clear, colourless solution.; Container Type: Cartridge; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2020-03-04
SPIOLTO ® RESPIMAT ® _2.5 MICROGRAMS / 2.5 MICROGRAMS SOLUTION FOR INHALATION_ _tiotropium (as bromide monohydrate) / olodaterol (as hydrochloride)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Spiolto Respimat. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Spiolto Respimat against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SPIOLTO RESPIMAT IS USED FOR Spiolto Respimat is used for the treatment of Chronic Obstructive Pulmonary Disease, also called COPD. COPD is a serious lung condition that can cause difficulty in breathing and constant coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm. Spiolto Respimat contains the active ingredients, tiotropium (as bromide monohydrate) and olodaterol (as hydrochloride). Tiotropium belongs to a group of medicines called anticholinergics. Olodaterol belongs to a group of medicines called long- acting bronchodilators. These medicines are used to relax the breathing tubes or air passages that carry air to and from the lungs and to keep the air passages in the lungs open and make breathing easier. Each dose of Spiolto Respimat will keep your air passages open for 24 hours. Regular use of Spiolto Respimat can also help when you have ongoing shortness of bre Leer el documento completo
SPIOLTO RESPIMAT (re-usable) PI0165-03 1 AUSTRALIAN PRODUCT INFORMATION - SPIOLTO RESPIMAT 2.5 MICROGRAMS/ 2.5 MICROGRAMS TIOTROPIUM/OLODATEROL SOLUTION FOR INHALATION (WITH DOSE INDICATOR) 1 NAME OF THE MEDICINE tiotropium (as bromide monohydrate) and olodaterol (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SPIOLTO RESPIMAT is a soft mist inhaler delivering tiotropium + olodaterol solution for inhalation. The SPIOLTO RESPIMAT cartridge containing the solution for inhalation is only for use with the SPIOLTO RESPIMAT re-usable inhaler. 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 micrograms tiotropium bromide monohydrate and 2.7 micrograms olodaterol hydrochloride. Two puffs equal one dose of 5 micrograms/5 micrograms. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipients with known effect: SPIOLTO RESPIMAT contains 0.0011 mg benzalkonium chloride in each actuation. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM SPIOLTO RESPIMAT solution for inhalation is a clear, colourless solution contained in a plastic container crimped into an aluminium cylinder (cartridge) with a dose counter, for use with the SPIOLTO RESPIMAT re-usable inhaler. The SPIOLTO RESPIMAT re-usable inhaler has a light-green coloured cap. The SPIOLTO RESPIMAT cartridge is only intended for use with the SPIOLTO RESPIMAT re-usable inhaler. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPIOLTO RESPIMAT is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 DOSE AND METHOD OF ADMINISTRATION SPIOLTO RESPIMAT is for oral inhalation only. ADULTS The recommended dose for adults is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the SPIOLTO RESPIMAT inhaler once daily, at the same time of the day (see S Leer el documento completo