Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
tiotropium bromide monohydrate, Quantity: 3.1235 microgram/actuation (Equivalent: tiotropium, Qty 2.5 microgram/actuation)
Boehringer Ingelheim Pty Ltd
Inhalation, conventional
Excipient Ingredients: purified water; hydrochloric acid; disodium edetate; benzalkonium chloride
Inhalation
3 x 1 cartridge (60 metered actuations) with dose indicator, 1 cartridge (60 metered actuations) with dose indicator
(S4) Prescription Only Medicine
COPD: SPIRIVA RESPIMAT is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). SPIRIVA RESPIMAT is indicated for the prevention of COPD exacerbations.,Asthma: SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.
Visual Identification: Clear, colourless solution.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2020-03-04
SPIRIVA ® RESPIMAT ® _SOLUTION FOR INHALATION_ _tiotropium_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Spiriva 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 Spiriva 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 SPIRIVA RESPIMAT IS USED FOR Spiriva Respimat is used to make breathing easier for patients with: • chronic obstructive pulmonary disease (COPD) • asthma. When used to treat asthma you should use Spiriva Respimat in addition to other medicines called inhaled corticosteroids. 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. Spiriva Respimat helps to improve your COPD condition and to prevent exacerbations (periodic worsening of symptoms) from occurring. Asthma is a serious lung condition where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke or other irritants. Spiriva Respimat improves breathing by relaxing the breathing tubes or air passages that carry air to and from the lungs. Spiriva Respimat contains the active ingredient tiotropium bromide monohydrate. It belongs to a group of medicines called anticholinergics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS Citiți documentul complet
SPIRIVA RESPIMAT (re-usable) PI0167-02 1 AUSTRALIAN PRODUCT INFORMATION – SPIRIVA ® RESPIMAT ® TIOTROPIUM SOLUTION FOR INHALATION (WITH DOSE INDICATOR) 1 NAME OF THE MEDICINE tiotropium (as bromide monohydrate) 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each puff contains tiotropium 2.5 micrograms, equivalent to tiotropium bromide monohydrate 3.1 micrograms. SPIRIVA RESPIMAT cartridges contain a clear, colourless, solution for inhalation filled into a plastic container which is inside an aluminium cylinder (cartridge) with a dose counter, for use with the SPIRIVA RESPIMAT re-usable inhaler. The SPIRIVA RESPIMAT re-usable inhaler has a green-coloured cap. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT re-usable inhaler. Excipients with known effect: SPIRIVA RESPIMAT contains 0.0011 mg benzalkonium chloride in each actuation. For the full list of excipients, see Section 6.1 List of excipients. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COPD SPIRIVA RESPIMAT is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). SPIRIVA RESPIMAT is indicated for the prevention of COPD exacerbations. ASTHMA SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma. 4.2 DOSE AND METHOD OF ADMINISTRATION SPIRIVA RESPIMAT is for oral inhalation only. The recommended dose of tiotropium using the SPIRIVA RESPIMAT is 5 micrograms. This is administered as two puffs once daily at the same time each day (see Section 4.2 Dose and Method of Administration, Instructions for Use and Handling). The recommended dose should not be exceeded. In the treatment of asthma, the full benefits will be apparent after several doses of SPIRIVA RESPIMAT. Paediatric population: In asthma, the recommended dose of tiotropium using the SPIRIVA RESPIMAT in patients 6 to 17 years of age is 5 micrograms. This is administe Citiți documentul complet