Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Fluticasone Propionate; Formoterol Fumarate Dihydrate
MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
R03AK07
250 mcg/actuation
AEROSOL, METERED
Fluticasone Propionate 250 mcg/actuation; Formoterol Fumarate Dihydrate 10 mcg/actuation
RESPIRATORY (INHALATION)
Prescription Only
Recipharm HC Limited
ACTIVE
2014-05-19
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 inhalation, suspension The canister contains white to off white liquid suspension. The canister is in a white actuator with a grey integrated dose indicator and a light grey mouthpiece cover. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This fixed-dose combination of fluticasone propionate and formoterol fumarate (_FLUTIFORM_ ®_ _ inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β 2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β 2 agonis Přečtěte si celý dokument
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 inhalation, suspension The canister contains white to off white liquid suspension. The canister is in a white actuator with a grey integrated dose indicator and a light grey mouthpiece cover. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This fixed-dose combination of fluticasone propionate and formoterol fumarate ( _FLUTIFORM_ ® inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β 2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β 2 agonist. Or • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β 2 agonist. _FLUTIFORM_ _® _ 50 microgram _/_ 5 microgram is indicated in adults, adolescents and children aged 5 years and above. _FLUTIFORM_ _® _ 125 microgram _/_ 5 microgram is indicated in adul Přečtěte si celý dokument