- Approval Id
- 95804e602fd467b4
- Drug Name
- BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation
- Product Name
- BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation
- Approval Number
- SIN16723P
- Approval Date
- 2023-03-02
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- AEROSOL, METERED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>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.</p>
<p><strong>Missed dose</strong></p>
<p>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.</p>
<p><strong>Children</strong></p>
<p>There is no relevant use of BREZTRI AEROSPHERE in children and adolescents (under 18 years of age) in the indication of COPD.</p>
<p><strong>Dosage in patients with renal impairment:</strong></p>
<p>No dosage adjustment is necessary for patients with renal impairment (see section 4.4 and section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Dosage in patients with hepatic impairment:</strong></p>
<p>No dosage adjustment is necessary for patients with hepatic impairment (see section 4.4 and section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Elderly:</strong></p>
<p>No dosage adjustment is necessary for elderly patients (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of administration</strong></p>
<p>For oral inhalation use.</p>
<p>For detailed instructions, refer to the patient leaflet – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Patients should be instructed how to administer the product correctly and advised to read the instructions for use carefully.</p>
<p>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®.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substances or any of the excipients.</p>
- Atc Code
- R03AL11
- Atc Item Name
- formoterol, glycopyrronium bromide and budesonide
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
