Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE
1units Units
Recipharm HC Limited
_Consumer Medication Information Leaflet (RiMUP) _ FLUTIFORM ® INHALER Fluticasone propionate/ formoterol fumarate dihydrate Page 1 Flutiform ® 50 microgram /5 microgram, per actuation pressurised inhalation, suspension Flutiform ® 125 microgram /5 microgram per actuation pressurised inhalation, suspension Flutiform ® 250 microgram /10 microgram per actuation pressurised inhalation, suspension READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1. What _FLUTIFORM_ ® inhaler is and what it is used for 2. How _FLUTIFORM_ ® inhaler works 3. Before you use _FLUTIFORM_ ® inhaler 4. How to use _FLUTIFORM_ ® inhaler 5.While you are using _FLUTIFORM_ ® inhaler 6. Possible side effects 7. Storage and disposal of _FLUTIFORM_ ® inhaler 8. Product description 9. Manufacturer 10. Marketing Authorization Holder 11. Date of revision WHAT _FLUTIFORM_ ® INHALER IS AND WHAT IT IS USED FOR Please note:- _FLUTIFORM_ ® pressurized inhalation, suspension is the product name, however throughout this leaflet it is shortened to _FLUTIFORM_ ® Inhaler. Sometimes this may refer to a specific strength. _FLUTIFORM_ ® is an inhaler (a pressurized inhalation, suspension) which contains two active ingredients; fluticasone propionate and formoterol fumarate dihydrate. This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this h Leggi il documento completo
R01107 720x200mm (CPRO-1-54) (L) V2 z _ITEM DESCRIPTION:_ _MANUFACTURER / PACKER:_ _CREATED BY:_ _DATE CREATED:_ _VERSION:_ _POR NO.:_ COLOUR(S): NON-PRINTING COLOURS PINK BLUE PURPLE BUFF _PACKAGI NG _ _ARTWORK _ _TEAM_ _Bard Pharmaceuticals Ltd._ _Cambridge Science Park, Milton Road, _ _Cambridge CB4 0GW, UK_ _Tel: +44 (0) 1223 424 444_ CG 31 MAR 2022 1 V11-2019 _PREFIXES_ N/A _ITEM CODE 2:_ N/A _DIMENSIONS FOLDED:_ 40x200mm _DIMENSIONS:_ 720X200mm _SECURITY CODE NO.:_ 801 _SECURITY CODE TYPE:_ Pharmacode _PATTERN REPEAT (MM):_ N/A _UNWIND NO.:_ N/A _DRAWING NO.:_ N/A _PMS NO.:_ N/A _TEMPLATE NO.:_ 720x200mm (CPRO-1-54) (L) V2 FLUTIFORM INH 50-5MCG 125-5MCG 250- 10MCG PIL MY BN R01107 RECIPHARM (FLUTIFORM) 12224 Black PMS 280 PMS 1505 MINIMUM FONT SIZE: 7pt FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1 FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1 31/03/2022 12:51 31/03/2022 12:51 1 NAME OF THE MEDICINAL PRODUCT FLUTIFORM ® 50 microgram/5 microgram, 125 microgram/5 microgram and 250 microgram/10 microgram per actuation pressurised inhalation, suspensions. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: • 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. • 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. • 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 microgram of fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inha Leggi il documento completo