BREZTRI AEROSPHERE 160/7.2/5 budesonide 160 mcg/glycopyrronium 7.2 mcg/formoterol fumarate dihydrate 5 mcg per actuation inhalation pressurised metered dose inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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)

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane

Administration route:

Inhalation

Units in package:

120 actuations, 28 actuations

Prescription type:

(S4) Prescription Only Medicine

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 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.

Product summary:

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; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-07-19

Patient Information leaflet

BREZTRI AEROSPHERE
® 160/7.2/5
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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

Summary of Product characteristics

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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