Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Glycopyrronium bromide 0.063mg equivalent to glycopyrronium 0.05 mg;
Novartis New Zealand Ltd
Glycopyrronium bromide 0.063 mg (equivalent to glycopyrronium 0.05 mg)
50 mcg
Powder filled inhalation capsule
Active: Glycopyrronium bromide 0.063mg equivalent to glycopyrronium 0.05 mg Excipient: Lactose monohydrate Magnesium stearate Orange capsule (Novartis)
Blister pack, PA/Al/PVC/Al in outer cardboard carton with 1 inhaler, sample pack, 6 capsules
Prescription
Prescription
Novartis Ringaskiddy Ltd
Once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Package - Contents - Shelf Life: Blister pack, PA/Al/PVC/Al in outer cardboard carton with 1 inhaler, sample pack - 6 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/Al/PVC/Al in outer cardboard carton with 1 inhaler, sample pack - 10 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/Al/PVC/Al in outer cardboard carton with 1 inhaler - 30 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/Al/PVC/Al in outer cardboard carton 3 x (30 capsules with 1 inhaler) - 90 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture
2013-04-02
SEEBRI ® BREEZHALER ® 1 SEEBRI ® BREEZHALER ® CAPSULES FOR INHALATION _Glycopyrronium bromide (glycopyrrolate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Seebri 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 Seebri 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 SEEBRI BREEZHALER IS USED FOR Seebri 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. Seebri 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. Seebri Breezhaler block tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. Seebri capsules for inhalation contain the active ingredient, glycopyrronium bromide (glycopyrrolate) in a capsule form. The capsules are for oral inhalation only. The powder from the capsule is inhaled (breathed into the lungs), using the Breezhaler ® inhalation device provided with the medicine. ASK YOUR DOCTOR I Belgenin tamamını okuyun
1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME SEEBRI Breezhaler Powder filled inhalation capsule 50 mcg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 63 microgram glycopyrronium bromide (glycopyrrolate) equivalent to 50 microgram glycopyrronium. The delivered dose (the dose that leaves the mouthpiece of the SEEBRI BREEZHALER inhaler) is equivalent to 44 microgram glycopyrronium. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM SEEBRI hard capsules are for oral inhalation only_._ SEEBRI is also supplied with a BREEZHALER inhalation device to permit oral inhalation of the contents of the capsule shell. 50 µ G INHALATION POWDER HARD CAPSULES Transparent orange capsules containing a white powder, with the product code GPL50 printed in black above a black bar and the company logo ( ) printed under a black bar. _ _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SEEBRI BREEZHALER is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dosage of SEEBRI BREEZHALER is the once-daily inhalation of the content of one 50 µ g SEEBRI capsule using the BREEZHALER inhaler. METHOD OF ADMINISTRATION SEEBRI capsules must be administered only by the oral inhalation route and only using the BREEZHALER inhaler. SEEBRI capsules must not be swallowed. SEEBRI BREEZHALER is recommended to be administered at the same time of the day each day. If a dose is missed, the missed dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. SEEBRI capsules must always be stored in the blister to protect from moisture, and only removed IMMEDIATELY BEFORE USE. 2 Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it. When prescribing SEEBRI BREEZHALER patients should be instructed on correct use of the inhaler. PATIENTS WITH REN Belgenin tamamını okuyun