Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 160 microgram/actuation; formoterol fumarate dihydrate, Quantity: 5 microgram/actuation; glycopyrronium bromide, Quantity: 9 microgram/actuation (Equivalent: glycopyrronium, Qty 7.2 microgram/actuation)
AstraZeneca Pty Ltd
Inhalation, pressurised
Excipient Ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane
Inhalation
120 actuations, 28 actuations
(S4) Prescription Only Medicine
Maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) who require treatment with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). BREZTRI AEROSPHERE 160/7.2/5 is not indicated for the initiation of therapy in COPD.
Visual Identification: White powder in propellant inside a canister with crimped valve and can-top dose indicator. Canister inside white actuator body with grey dust cap.; Container Type: Aerosol Can - Metered Dose; Container Material: Epoxy-coated Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2022-08-11
BREZTRI AEROSPHERE ® 160/7.2/5 B R E Z T R I A E R O S P H E R E ® 1 6 0 / 7 . 2 / 5 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BREZTRI AEROSPHERE? BREZTRI AEROSPHERE contains three active ingredients in the one puffer: budesonide, glycopyrronium, and formoterol (eformoterol) fumarate dihydrate. BREZTRI AEROSPHERE is used to treat chronic obstructive pulmonary disease (COPD). For more information, see Section 1. Why am I using BREZTRI AEROSPHERE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BREZTRI AEROSPHERE? Do not use if you have ever had an allergic reaction to BREZTRI AEROSPHERE or any of the ingredients listed at the end of CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use BREZTRI AEROSPHERE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BREZTRI AEROSPHERE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BREZTRI AEROSPHERE? • The recommended dose is 2 puffs (actuations) of BREZTRI AEROSPHERE twice a day (2 puffs in the morning, 2 puffs at night) • Each pack of BREZTRI AEROSPHERE contains an instruction leaflet that tells you the correct way to use your inhaler. Please read this carefully. More instructions can be found in Section 4. How do I use BREZTRI AEROSPHERE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BREZTRI AEROSPHERE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using BREZTRI AEROSPHERE • See your doctor regularly to make sure that your COPD is not getting worse. If you find that your symptoms are worsening or not as well controlled as usual contact your doctor as it's important th Διαβάστε το πλήρες έγγραφο
1 of 21 AUSTRALIAN PRODUCT INFORMATION BREZTRI AEROSPHERE ® 160/7.2/5 (BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE) PRESSURISED METERED DOSE INHALER 1 NAME OF THE MEDICINE Budesonide Glycopyrronium (as glycopyrronium bromide; also known as glycopyrrolate) Formoterol (eformoterol) fumarate dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Table 1 below provides the quantities of the active moieties and their salts as the delivered dose (ex- mouthpiece/quantity delivered to the patient). In Australia, BREZTRI AEROSPHERE 160/7.2/5 is labelled as the delivered dose per actuation (puff) of budesonide, glycopyrronium and formoterol (eformoterol) fumarate dihydrate (herein referred to as “formoterol”). This may differ to other regions in the world. TABLE 1 BREZTRI AEROSPHERE ACTIVE INGREDIENT QUANTITIES ACTIVE INGREDIENT QUANTITY PER ACTUATION QUANTITY PER DOSE (2 ACTUATIONS) Budesonide 160 µg* 320 µg Glycopyrronium bromide (glycopyrrolate) 9 µg 18 µg Equivalent to glycopyrronium 7.2 µg* 14.4 µg Formoterol (eformoterol) fumarate dihydrate 5 µg* 10 µg Equivalent to formoterol (eformoterol) fumarate 4.8 µg 9.6 µg *Quantity presented on the product packaging. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Pressurised inhalation 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) who require treatment with a combination of an inhaled corticosteroid (ICS), a long-acting β 2 -agonist (LABA), and a long-acting muscarinic antagonist (LAMA). BREZTRI AEROSPHERE 160/7.2/5 is not indicated for the initiation of therapy in COPD. 2 of 21 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS (18 YEARS AND OVER) _ The recommended dose is two actuations twice daily (two actuations in the morning and two actuations in the evening). Patients should be advised not to take more than two actuations Διαβάστε το πλήρες έγγραφο