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HSA Approval

BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation

SIN16723P

BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation

BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation

March 2, 2023

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantASTRAZENECA SINGAPORE PTE LTD
Licence HolderASTRAZENECA SINGAPORE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

AEROSOL, METERED

**4.2 Posology and method of administration** The recommended and maximum dose is two inhalations of BREZTRI AEROSPHERE 160/7.2/5.0 twice daily, in the morning and in the evening, by the orally inhaled route only. **Missed dose** If a dose is missed, it should be taken as soon as possible, and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose. **Children** There is no relevant use of BREZTRI AEROSPHERE in children and adolescents (under 18 years of age) in the indication of COPD. **Dosage in patients with renal impairment:** No dosage adjustment is necessary for patients with renal impairment (see section 4.4 and section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Dosage in patients with hepatic impairment:** No dosage adjustment is necessary for patients with hepatic impairment (see section 4.4 and section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Elderly:** No dosage adjustment is necessary for elderly patients (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** For oral inhalation use. For detailed instructions, refer to the patient leaflet – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Patients should be instructed how to administer the product correctly and advised to read the instructions for use carefully. Patients who find it difficult to co-ordinate actuation with inhalation may use BREZTRI AEROSPHERE with a spacer to ensure proper administration of the product. BREZTRI AEROSPHERE can be used with spacer devices including the Aerochamber Plus® Flow Vu®.

RESPIRATORY (INHALATION)

Medical Information

**4.1 Therapeutic indications** Maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with moderate to very severe chronic obstructive pulmonary disease (COPD) (see Section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**4.3 Contraindications** Hypersensitivity to the active substances or any of the excipients.

R03AL11

formoterol, glycopyrronium bromide and budesonide

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

AstraZeneca Dunkerque Production (AZDP)

Active Ingredients

Budesonide

160 μg/actuation

Budesonide

Glycopyrronium bromide eqv Glycopyrronium

7.2 μg/actuation

Glycopyrronium

Formoterol fumarate dihydrate

5.0 μg/actuation

Aluminum sulfate

Documents

Package Inserts

Breztri Aerosphere inhaler PI.pdf

Approved: March 2, 2023

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