Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Tiotropium bromide monohydrate eqv tiotropium
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
R03BB04
SOLUTION
Tiotropium bromide monohydrate eqv tiotropium 0.0025 mg/actuation
RESPIRATORY (INHALATION)
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG
ACTIVE
2020-02-18
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1 SPIRIVA RESPIMAT RE-USABLE 2.5 MICROGRAM, SOLUTION FOR INHALATION 1. NAME OF THE MEDICINAL PRODUCT SPIRIVA RESPIMAT re-usable 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. PHARMACEUTICAL FORM Inhalation solution Clear, colourless, inhalation solution 3.1 PRODUCT DESCRIPTION SPIRIVA RESPIMAT re-usable 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 re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Asthma SPIRIVA RESPIMAT re-usable 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. abcd 2 In the treatment of asthma, the full benefit will be apparent after several doses of the medicinal product. 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 (creatinin Baca dokumen lengkapnya