देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Tiotropium bromide monohydrate 3.125ug equivalent to Tiotropium 2.5 µg/dose
Boehringer Ingelheim (NZ) Limited
Tiotropium bromide monohydrate 3.125 µg (equivalent to Tiotropium 2.5 µg/dose)
2.5 mcg/dose
Solution for inhalation
Active: Tiotropium bromide monohydrate 3.125ug equivalent to Tiotropium 2.5 µg/dose Excipient: Benzalkonium chloride Disodium edetate Hydrochloric acid Purified water
Inhaler, metered, Respimat device + 4.5mL cartridge, 60 dose units
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
SPIRIVA RESPIMAT is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life.
Package - Contents - Shelf Life: Inhaler, metered, Respimat device + 4.5mL cartridge - 60 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze 3 months opened stored at or below 25°C. Do not freeze
2008-08-12
SPIRIVA RESPIMAT NZ CMI v05 1 SPIRIVA ® RESPIMAT ® _SOLUTION FOR INHALATION _ _tiotropium _ CONSUMER MEDICINE INFORMATION 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.medsafe.govt.nz/Consumers/ cmi/CMIForm.asp 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 and to reduce exacerbations (periodic worsening of symptoms). Spiriva Respimat contains the active ingredient tiotropium bromide mo पूरा दस्तावेज़ पढ़ें
SPIRIVA RESPIMAT NZ DS v03 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME SPIRIVA RESPIMAT ® 2.5 microgram, solution for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The delivered dose is 2.5 micrograms tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 micrograms tiotropium bromide monohydrate. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipients with known effect: This medicine contains 0.0011 mg benzalkonium chloride in each actuation. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clear, colourless, solution for inhalation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COPD SPIRIVA RESPIMAT is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life. Asthma SPIRIVA RESPIMAT is indicated as add-on maintenance treatment for the improvement of asthma symptoms and reduction of exacerbations, in adult patients with asthma who remain symptomatic on at least inhaled corticosteroids. SPIRIVA RESPIMAT is indicated as add-on maintenance treatment for the improvement of respiratory function in patients aged 6 to 17 years old with moderate asthma who remain symptomatic on at least inhaled corticosteroids. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose SPIRIVA RESPIMAT is intended for oral inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see Patient’s instructions for use and handling). Two puffs from the Respimat inhaler comprise one medicinal dose. The recommended dose for adults is 5 microgram tiotropium given as two puffs from the RESPIMAT inhaler once daily, at the same time of the day. The recommended dose should not be exceeded. In the treatment of asthma, the full benefits will be apparent after several do पूरा दस्तावेज़ पढ़ें