Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
indacaterol maleate, Quantity: 389 microgram (Equivalent: indacaterol, Qty 300 microgram)
Novartis Pharmaceuticals Australia Pty Ltd
Indacaterol maleate
Capsule, hard
Excipient Ingredients: Gelatin; lactose monohydrate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; brilliant blue FCF aluminium lake; industrial methylated spirit; iron oxide black; ethanol; Shellac; strong ammonia solution; sulfuric acid
Inhalation
10 capsules + 1 Breezhaler, 60 capsules + 2 Breezhalers, 30 capsules + 1 Breezhaler
(S4) Prescription Only Medicine
ONBREZ BREEZHALER is a long-acting beta2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (COPD).
Visual Identification: Colourless capsule, marked in blue with Novartis logo and "IDL 300"; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-08-03
ONBREZ ® BREEZHALER ® CAPSULES FOR INHALATION _Indacaterol maleate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Onbrez Breezhaler. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you having Onbrez Breezhaler against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ONBREZ BREEZHALER IS USED FOR Onbrez capsules are for the treatment of chronic obstructive pulmonary disease, also called COPD. COPD is a serious lung condition that can cause difficulty in breathing, and constant coughing. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm. Onbrez capsules for inhalation belong to a group of medicines called bronchodilators. These medicines are used to keep the air passages in the lungs open and make breathing easier. Onbrez capsules make breathing easier by opening the small air passages in the lungs and helping them to remain relaxed and open. Onbrez is a long acting bronchodilator. Each dose of Onbrez will keep your air passages open and relieve chest tightness and wheezing for 24 hours. Onbrez capsules for inhalation contain the active ingredient, indacaterol maleate in a capsule form. The capsules are for oral inhalation only. The powder from the capsule is inhaled (breathed into the lungs), Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – ONBREZ ® BREEZHALER ® (INDACATEROL MALEATE) HARD CAPSULE FOR INHALATION 1 NAME OF THE MEDICINE indacaterol maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ONBREZ hard capsules are for oral inhalation only. ONBREZ is also supplied with a BREEZHALER inhalation device to permit oral inhalation of the contents of the capsule shell. 150 MICROGRAMS Each capsule contains 194 g indacaterol maleate equivalent to 150 g indacaterol. The delivered dose (the dose that leaves the mouthpiece of the BREEZHALER device) is equivalent to 120 g indacaterol. 300 MICROGRAMS Each capsule contains 389 g indacaterol maleate equivalent to 300 g indacaterol. The delivered dose (the dose that leaves the mouthpiece of the BREEZHALER device) is equivalent to 240 g indacaterol. EXCIPIENTS: lactose monohydrate and gelatin. 3 PHARMACEUTICAL FORM Hard capsule containing powder for oral inhalation. 150 MICROGRAMS Black product code “IDL 150” printed above and black company logo printed under black bar on clear colourless hard capsule. 300 MICROGRAMS Blue product code “IDL 300” printed above and blue company logo printed under blue bar on clear colourless hard capsule. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ONBREZ BREEZHALER is a long-acting β2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease. (See Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical Trials) 2 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage _Adults with COPD _ The recommended and usual dosage of ONBREZ BREEZHALER is the once-daily inhalation of the content of one 150 g ONBREZ capsule using the BREEZHALER inhaler. The dosage should only be increased on medical advice. Once-daily inhalation of the content of one 300 g ONBREZ capsule, using the BREEZHALER inhaler, has only been shown to provide additional clinical benefit to some patien Prečítajte si celý dokument