Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Fluticasone furoate 200ug; ; Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg;
GlaxoSmithKline NZ Limited
Fluticasone furoate 200 µg
200mcg/25mcg
Powder for inhalation
Active: Fluticasone furoate 200ug Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg Excipient: Lactose monohydrate Magnesium stearate
Prescription
Glaxo Operations UK Limited t/a Glaxo Welcome Operations
Indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.
Package - Contents - Shelf Life: Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 14 dose units - 24 months from date of manufacture stored at or below 30°C protect from moisture 1 months opened stored at or below 30°C protect from moisture - Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 30 dose units - 24 months from date of manufacture stored at or below 30°C protect from moisture 1 months opened stored at or below 30°C protect from moisture
2012-08-27
BREO ELLIPTA 1 BREO ELLIPTA _Fluticasone furoate 100 or 200 micrograms and vilanterol (as trifenatate) 25 micrograms per inhalation _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using BREO ELLIPTA. This leaflet answers some common questions about BREO ELLIPTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking BREO ELLIPTA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BREO ELLIPTA IS USED FOR BREO ELLIPTA is used to treat asthma and chronic obstructive pulmonary disease (COPD). To use BREO ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler. Asthma is when the muscles surrounding the smaller airways become tight (bronchoconstriction), swollen and irritated (inflammation). Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. COPD is a long-term condition that slowly gets worse. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. BREO ELLIPTA has been shown to reduce flare-ups of COPD symptoms. BREO ELLIPTA contains two active ingredients: fluticasone furoate and vilanterol trifenatate. Fluticasone furoate belongs to a group of medicines called _corticosteroids_ , often simply called _steroids_ . Corticosteroids are used to reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and can ease breathing problems. Corticosteroids also help to prevent attacks of asthma. Vilanterol trifenatate belongs to a group of medicines called _bronchodilators_ . It relaxes the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and ou Прочитајте комплетан документ
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME BREO ELLIPTA fluticasone furoate (100 micrograms or 200 micrograms)/vilanterol (as trifenatate) (25 micrograms), powder for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _BREO ELLIPTA 100 micrograms/25 micrograms:_ Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). _BREO ELLIPTA 200 micrograms/25 micrograms:_ Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). Excipients with known effect: Each delivered dose contains approximately 25 mg of lactose (as monohydrate). For the full list of excipients, see Section 6.1 - List of excipients. 3. PHARMACEUTICAL FORM Powder for inhalation. White powder in a light grey inhaler (Ellipta) with a pale blue mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Asthma BREO ELLIPTA is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta 2 -agonist and inhaled corticosteroid) is appropriate. Chronic Obstructive Pulmonary Disease (COPD) BREO ELLIPTA is indicated for symptomatic treatment of adult patients with COPD with a FEV 1 < 70% predicted normal (post-bronchodilator) in patients with an exacerbation history. 2 4.2. DOSAGE AND METHOD OF ADMINISTRATION DOSE Asthma _Adults and adolescents aged 12 years and over _ One inhalation of BREO ELLIPTA 100/25 micrograms once daily or One inhalation of BREO ELLIPTA 200/25 micrograms once daily Patients usually experience an improvement in lung function within 15 minut Прочитајте комплетан документ