Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
Tiotropium Bromide Monohydrate 0.003124mg eqv. Tiotropium
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
R03BB04
0.0025mg/actuation
SOLUTION
Tiotropium Bromide Monohydrate 0.003124mg eqv. Tiotropium 0.0025mg/actuation
RESPIRATORY (INHALATION)
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co.KG
ACTIVE
2009-04-30
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0269- 10 (SG) 21082019 1 SPIRIVA RESPIMAT 2.5 MICROGRAM, SOLUTION FOR INHALATION 1. NAME OF THE MEDICINAL PRODUCT SPIRIVA RESPIMAT 2.5 microgram, solution for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate. The delivered dose is the dose which is available for the patient after passing the mouthpiece. For a full list of excipients, see section 6.1. 3. PRODUCT DESCRIPTION SPIRIVA RESPIMAT Solution for Inhalation is a clear, colourless solution of tiotropium bromide monohydrate filled into a 4.5ml cartridge. Each cartridge providing 60 puffs (30 medicinal doses). The solution is to be used with a Respimat Inhaler. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COPD SPIRIVA RESPIMAT is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). 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 POSOLOGY AND METHOD OF ADMINISTRATION Posology The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see 4.2). 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 benefit will be apparent after several doses of the medicinal product. abcd 0269- 10 (SG) 21082019 2 Special populations Geriatric patients can use tiotropium bromide at the recommended dose. Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance 50 ml/min, see 4.4 and 5.2). Hepatically impaired patients can use tiot Đọc toàn bộ tài liệu