국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
DKSH MALAYSIA SDN BHD
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
60capsule Capsules
Laboratorios Liconsa
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FLUDALT DUO _Fluticasone / Salmeterol (250/50mcg) inhalation powder hard capsules _ _Fluticasone / Salmeterol (500/50mcg) inhalation powder hard capsules _ 1 What is in this leaflet 1. WHAT FLUDALT DUO IS USED FOR 2. HOW FLUDALT DUO WORKS 3. BEFORE YOU USE FLUDALT DUO 4. HOW TO USE FLUDALT DUO 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF FLUDALT DUO 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 1. WHAT FLUDALT DUO IS USED FOR Fludalt Duo is indicated in regular treatment of: - Reversible Obstructive Airways Disease (ROAD), including asthma - Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema 2. HOW FLUDALT DUO WORKS Fludalt DUO contains two medicines, fluticasone propionate and salmeterol: • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. • Salmeterol is a long-acting bronchodilator. It helps the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours. Fludalt DUO helps to stop breathlessness and wheeziness coming on. It does not work once you are breathless or wheezy. If that happens you need to use a fast acting ‘reliever’ medication, such as salbutamol. 3. BEFORE YOU USE FLUDALT DUO WHEN YOU MUST NOT USE IT If you are allergic to fluticasone propionate, salmeterol xinafoate or to the other ingredients of this medicine (listed in section 8). BEFORE YOU START TO USE IT Talk to your doctor or, pharmacist or nurse before using Fludalt DUO. Your doctor will supervise your treatment more closely if you have medical conditions such as: • Heart disease, including an irregular or fast heartbeat • Overactive thyroid gland • High blood pressure • Diabetes mellitus (Fludalt DUO may increase your blood sugar) • Low potassium in your blood • Tuberculosis (TB) now or in the past If you have ever had any of these conditions, tell your docto 전체 문서 읽기
FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE 7mm 126 mm 140 mm 7mm 540 mm 7mm 7mm 526 mm LAETUS CENTERED WITHIN 37 MM FINAL SIZE FOLDED 7mm 126 mm 140 mm 7mm 34 mm 34 mm 472 mm READING DIRECTION READING DIRECTION LICONSA CODE DKSH MALAYSIA SDN BHD B-11-01, The Ascent, Paradigm, No.1, Jalan SS7/26A, Kelana Jaya, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia LABORATORIOS LICONSA S.A. Avenida Miralcampo 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares, Guadalajara, SPAIN. 29 July 2020 DKSH MALAYSIA SDN BHD B-11-01, The Ascent, Paradigm, No.1, Jalan SS7/26A, Kelana Jaya, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia Material # / Product : LF FLUTI-SALM 250/50MCG 500/50MCG EXELTIS MY Date : 06.10.20 Version : C Substitutes mat. # : - **** BLACK **** **** **** **** **** BLACK **** **** **** **** DIE CUT Scale : 100 % Dimensions : 140 x 540 ± 1 mm Drawing: 0234 (*) Customer shall be responsible for the contents of the approved artworks, text and colours of the printed material reflected in this drawing. Therefore, Customer shall bear any and all cost and/or expense, and it shall keep Laboratorios Liconsa harmless from any claim, cost and/or expenses, related to the correctness and accuracy of such information. (*) PLEASE DON'T DELETE ANY LAYERS FOR THE CORRECT REVISION Cause: LAUNCH CUSTOMER CHANGE INTERNAL CHANGE LABORATORIOS LICONSA MATERIAL TYPE : LEAFLET Pantones: Line 1: Front Side Line 2: Back Side Line 3: Technical colour Laetus : ***** Folded: Folded dimensions: 1 fold in horizontal to 140 x 270 mm + 3 folds in horizontal to 140 x 34 mm NO YES PRINT SECURITY MARGINS FINAL FOLDED Drawed by: (Chemo Artwork Technician) Approved by Customer : (Regulatory Affair or Quality Assurance) / Signature & Date With the signed proof of this file you commit to have had reviewed and agreed with the following points as part of your review: - Keyline used / Free varnish areas / Colors / Text. - Prefixes order for variable info (If the or 전체 문서 읽기