Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIOTROPIUM
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
TIOTROPIUM
4.0ml mL; 1 respimat pro inhaler and 1 cartridge containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units; 2) 1 cartridge (refill) containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
SPIRIVA RESPIMAT SOLUTION FOR INHALATION Tiotropium (2.5 microgram) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What SPIRIVA RESPIMAT is used for 2. How SPIRIVA RESPIMAT works 3. Before you use SPIRIVA RESPIMAT 4. How to use SPIRIVA RESPIMAT 5. While you are using it 6. Side effects 7. Storage and Disposal of SPIRIVA RESPIMAT 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SPIRIVA RESPIMAT IS USED FOR SPIRIVA RESPIMAT helps people who have chronic obstructive pulmonary disease (COPD) or asthma to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the inflammation of the mucous membrane in the airway tubes and the condition in which the air sacs of the lungs are damaged and enlarged, causing breathlessness. Asthma is a long- term disease characterised by airway inflammation and narrowing of the airways. When used to treat asthma you should use SPIRIVA RESPIMAT as add-on maintenance for patients aged 6 years and above with severe condition. HOW SPIRIVA RESPIMAT WORKS SPIRIVA RESPIMAT is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of SPIRIVA RESPIMAT can also help you when you have on-going shortness of breath related to your disease and will help to minimise the effects of the disease on your everyday life. Daily use of SPIRIVA RESPIMAT will also help to prevent any sudden, short-term worsening of your COPD symptoms which may last for several days. For correct dosing of SPIRIVA RESPIMAT please see Section 4. How to use SPIRIVA RESPIMAT and the instructions for use provided on the other side of the leaflet. BEFORE YOU USE SPIRIVA RESPIMAT - _When you must not use it _ You should not use SPIRIVA REPIMAT if you are allergic (hypersensitive) to tiotropium, its active ingredient or inactive ingredients listed under Section 8. Product Description. _ _ You sh Baca dokumen lengkap
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. PHARMACEUTICAL FORM Inhalation solution Clear, colourless, inhalation solution 3.1 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 Tiotropium 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 severe asthma who experienced one or more severe asthma exacerbations in the preceding year. 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 Instructions for Use). 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 Spiriva Respimat. 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 (crea Baca dokumen lengkap