Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INDACATEROL
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
INDACATEROL
30Capsule Capsules
Siegfried Barbera, S.L.
_Consumer Medication Information Leaflet (RiMUP) _ ONBREZ ® BREEZHALER ® Indacaterol maleate ( 150 microgram and 300 microgram) _ _ 1 WHAT IS IN THIS LEAFLET 1. WHAT ONBREZ BREEZHALER IS USED FOR 2. HOW ONBREZ BREEZHALER WORKS 3. BEFORE YOU USE ONBREZ BREEZHALER 4. HOW TO USE ONBREZ BREEZHALER 5. WHILE YOU ARE USING ONBREZ BREEZHALER 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF ONBREZ BREEZHALER 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER WHAT ONBREZ BREEZHALER IS USED FOR Onbrez Breezhaler _ _ contains an active substance called indacaterol. This medicine _ _ belongs to a group of medicines called bronchodilators. When you inhale it, it helps you breathe more easily. You use it with a device called an inhaler (only use the Onbrez Breezhaler _ _ inhaler contained in this pack). In this pack, you will find an inhaler and capsules (in blister strips) that contain the medicine as inhalation powder. The Onbrez Breezhaler _ _ inhaler enables you to inhale the medicine contained in a capsule. Onbrez Breezhaler is used to make breathing easier for people who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). Regular, once a day, use of Onbrez Breezhaler _ _ will help to minimise the effects of the disease on your everyday life. HOW ONBREZ BREEZHALER WORKS Onbrez Breezhaler _ _ relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making it easier for air to get in and out. If you have any questions about how Onbrez Breezhaler _ _ _ _ works or why it has been prescribed for you, ask your doctor. BEFORE YOU USE ONBREZ BREEZHALER Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _When you must not use it _ • If you have ever had an unusual or allergic reaction to indacaterol or to any other ingredients of this product listed at the end of this leaflet. • If either of these apply to Baca dokumen lengkap
Regulatory Affairs ONBREZ BREEZHALER (INDACATEROL MALEATE) 150 microgram and 300 microgram_ _inhalation powder hard capsules MALAYSIA PACKAGE INSERT (JUN 21) Swiss PI (Warnings-Lactose; Interaction-Drugs known to prolong QTc interval; Overdose-acute intoxaication statement; PK absorption; Non- clinical-chronic toxicity study statement) FOR PROMOTIONAL MATERIALS PLEASE QUOTE THE FOLLOWING: PI RD 27 JUL 2020; APPR IPL Author: Sowjanya Chitturi CDS Author: Souhayla El Maadidi GLC approval: 09-Jun-2020 Effective date: 27-Jul-2020 Safety Label Change (SLC) Tracking Number: 2020-PSB/GLC-1125-s Document status: Final Number of pages: 23 Novartis Page 2 Malaysia Package Insert 27-Jul-2020 Onbrez Breezhaler ONBREZ ® BREEZHALER ® Long-acting beta 2 -adrenergic agonist. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Inhalation powder, hard capsules. 150 microgram: Black product code “IDL 150” printed above and black company logo printed under black bar on yellowish transparent (uncolored) capsule. 300 microgram: Blue product code “IDL 300” printed above and blue company logo printed under blue bar on yellowish transparent (uncolored) capsule. ACTIVE SUBSTANCE 150 MICROGRAM INHALATION POWDER HARD CAPSULES Each capsule contains 194 microgram indacaterol maleate equivalent to 150 microgram indacaterol. The delivered dose (the dose that leaves the mouthpiece of the Onbrez Breezhaler inhaler) is equivalent to 120 microgram indacaterol. 300 MICROGRAM INHALATION POWDER HARD CAPSULES Each capsule contains 389 microgram indacaterol maleate equivalent to 300 microgram indacaterol. The delivered dose (the dose that leaves the mouthpiece of the Onbrez Breezhaler inhaler) is equivalent to 240 microgram indacaterol. Certain dosage strengths may not be available in all countries. EXCIPIENTS Lactose monohydrate and gelatin. INDICATIONS Onbrez Breezhaler is a long-acting beta 2 -agonist indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (C Baca dokumen lengkap