البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
TIOTROPIUM
Profind Wholesale Ltd
TIOTROPIUM
2.5 Mcg/Dose
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 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 PHARMACEUTICAL FORM Solution for Inhalation _Product imported from France:_ Clear, colourless, solution for inhalation 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. 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 tiotropium bromide at the recommended dose (see 5.2). Paediatric patients: Spiriva Respimat is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy (see 5.1 and 5.2). To ensure proper administration of the medicinal pro اقرأ الوثيقة كاملة