Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Fluticasone furoate 100ug; ; Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation); ; Vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base);
GlaxoSmithKline NZ Limited
Powder for inhalation
Active: Fluticasone furoate 100ug Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation) Vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base) Excipient: Lactose monohydrate Magnesium stearate
Prescription
TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with a long-acting muscarinic receptor antagonist (LAMA) + long-acting beta2-receptor agonist (LABA) + inhaled corticosteroid (ICS). TRELEGY ELLIPTA should not be used for the initiation of COPD treatment.
Package - Contents - Shelf Life: Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with dessicant. Sample pack. - 14 dose units - 1 months opened stored at or below 30°C protect from moisture 24 months from date of manufacture stored at or below 30°C protect from moisture - Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with dessicant. - 30 dose units - 1 months opened stored at or below 30°C protect from moisture 24 months from date of manufacture stored at or below 30°C protect from moisture
2018-02-21
TRELEGY ELLIPTA 1 TRELEGY ELLIPTA 100/62.5/25 AND 200/62.5/25 _Fluticasone furoate 100 or 200 micrograms, umeclidinium (as bromide) 62.5 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 TRELEGY ELLIPTA. This leaflet answers some common questions about TRELEGY 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 TRELEGY 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 TRELEGY ELLIPTA IS USED FOR TRELEGY ELLIPTA is a dry powder inhaler. When you breathe in using the inhaler, the medicine is deposited into the lungs. TRELEGY ELLIPTA is used to treat asthma or chronic obstructive pulmonary disease (COPD). 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. TRELEGY ELLIPTA contains three active ingredients: fluticasone furoate, umeclidinium (as bromide) and vilanterol (as trifenatate). Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. They are not ‘anabolic steroids’ which are the steroids sometimes misused by athletes. Corticosteroids are used to reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and so ease breathing problems. Umeclidinium and vilanterol belong to a group of medicines called bronchodilators. They work together t Đọc toàn bộ tài liệu
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate (100 micrograms)/umeclidinium (as bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25 micrograms), powder for inhalation. TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate (200 micrograms)/umeclidinium (as bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25 micrograms), powder for inhalation. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) containing 92 micrograms fluticasone furoate, 55 micrograms umeclidinium (equivalent to 65 micrograms umeclidinium [as bromide]) and 22 micrograms vilanterol (as trifenatate) OR 184 micrograms fluticasone furoate, 55 micrograms umeclidinium (equivalent to 65 micrograms umeclidinium [as bromide]) and 22 micrograms vilanterol (as trifenatate). Each pre-dispensed dose contains either 100 micrograms fluticasone furoate, 62.5 micrograms umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide) and 25 micrograms vilanterol (as trifenatate) or 200 micrograms fluticasone furoate, 62.5 micrograms umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide) and 25 micrograms vilanterol (as trifenatate). Excipient with known effect: Each delivered dose contains approximately 25 milligrams 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 beige mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ASTHMA TRELEGY ELLIPTA is indicated for the maintenance treatment of asthma in adult patients who are not adequately controlled with a combination of inhaled corticosteroid and a long- acting beta 2 -agonist. 2 COPD TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with a long- acting muscarinic receptor Đọc toàn bộ tài liệu