国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
Budesonide (micronised); Formoterol fumarate dihydrate (micronised)
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
R03AK07
POWDER, METERED
Budesonide (micronised) 320 mcg / inhalation; Formoterol fumarate dihydrate (micronised) 9 mcg / inhalation
RESPIRATORY (INHALATION)
Prescription Only
Norton (Waterford) Limited
ACTIVE
2020-12-07
2156 2156 131522_S1 - P: BUDESONIDE/FORMOTEROL, SG, DRY POWDER FOR INHALATION 160MCG/4.5MCG 03 10.11.2023 RB 04.12.2023 320 x 640 Norton (Waterford) Limited 8 pt Profile Black PMS 375 PMS 696 SPEC. REFERENCE: MPSI092856 SAP CODE: PE3771V3 160 MCG/4,5 MCG Dry powder for inhalation BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE PE3771V3 160 MCG/4.5 MCG Dry powder for inhalation BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT DUORESP SPIROMAX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUORESP SPIROMAX 3. HOW TO USE DUORESP SPIROMAX 4. POSSIBLE SIDE EFFECTS 5.HOW TO STORE DUORESP SPIROMAX 6.CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DUORESP SPIROMAX IS AND WHAT IT IS USED FOR DuoResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate. • Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily. • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily. Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD). ASTHMA DuoResp Spiromax can be prescribed for asthma i 完全なドキュメントを読む
1 NAME OF THE MEDICINAL PRODUCT DuoResp ® Spiromax ® Dry powder for inhalation 320 mcg/9 mcg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate. Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. White powder. White inhaler with a semi-transparent wine red mouthpiece cover. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β 2 adrenoceptor agonist) is appropriate: − in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β 2 adrenoceptor agonists. or − in patients already adequately controlled on both inhaled corticosteroids and long-acting β 2 adrenoceptor agonists. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Symptomatic treatment of patients with COPD with FEV1 <70% predicted normal (post-bronchodilator) and a history of repeated exacerbations, despite regular long-acting bronchodilator therapy (see section Special warnings and precautions for use). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ASTHMA_ DuoResp Spiromax is not intended for the initial management of asthma. The dosage of the components of DuoResp Spiromax is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β 2 -agonists and/or corticosteroid 完全なドキュメントを読む