国: イスラエル
言語: 英語
ソース: Ministry of Health
FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE DIHYDRATE
RAFA LABORATORIES LTD
R01AD08
PRESSURISED SUSPENTION FOR INHALATION
FLUTICASONE PROPIONATE 0.05 MG/DOSE; FORMOTEROL FUMARATE DIHYDRATE 0.005 MG/DOSE
INHALATION
Required
RECIPHARM HC LIMITED, UK
FLUTICASONE
FLUTICASONE
The regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long -acting β2 agonist) is appropriate:• For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.• For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.Flutiform 50mcg/5mcg inhaler is indicated in adults, adolescents and children aged 5 years and above.
2018-07-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only FLUTIFORM 50/5 FLUTIFORM 125/5 FLUTIFORM 250/10 SUSPENSION FOR INHALATION ACTIVE INGREDIENTS: Each FLUTIFORM 50/5 inhaler actuation contains: Fluticasone propionate 50 mcg and formoterol fumarate dihydrate 5 mcg. Each FLUTIFORM 125/5 inhaler actuation contains: Fluticasone propionate 125 mcg and formoterol fumarate dihydrate 5 mcg. Each FLUTIFORM 250/10 inhaler actuation contains: Fluticasone propionate 250 mcg and formoterol fumarate dihydrate 10 mcg. For the list of additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. The use of Flutiform 50/5 is not intended for children under 5 years of age. The use of Flutiform 125/5 is not intended for children under 12 years of age. The use of Flutiform 250/10 is not intended for children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for treatment of asthma patients, in cases suited for combined treatment of corticosteroids and long-acting beta agonists by inhalation. Fluticasone propionate helps to reduce swelling and inflammation in the lungs. Formoterol fumarate dihydrate is a long-acting bronchodilator which helps the airways in your lungs stay open, making it easier for you to breathe. THERAPEUTIC GROUPS: Fluticasone propionate: corticosteroids. Formoterol fumarate dihydrate: beta agonist (long-acting). 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to the active ingredients or to any of the ot 完全なドキュメントを読む
DL-Flutiform-SPC-18- April 2023-02 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FLUTIFORM 50 /5 FLUTIFORM 125 /5 FLUTIFORM 250 /10 PRESSURISED SUSPENSION FOR INHALATION 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 micrograms of fluticasone propionate and 4.5 micrograms 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 micrograms of fluticasone propionate and 4.5 micrograms 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 micrograms of fluticasone propionate and 9.0 micrograms of formoterol fumarate dihydrate. Excipient with known effect Each actuation contains 1 mg ethanol. For the 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 The regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long – acting β2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist. Or • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. 2 _FLUTIFORM _50/5 inhaler is indicated in adults, adolescents and children aged 5 years and above. _FLUTIFORM _125/5 inhaler is indicated in adults and adolescents aged 12 years and above. _FLUTIFORM _250/10 inhal 完全なドキュメントを読む