Product Details

Ultibro Breezhaler

Indacaterol + Glycopyrronium
110 mcg + 50 mcg
Powder for Inhalation
Capsule

DIN/PIN/NPN

02418282

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2015-05-28  

Unit Price

2.5830

Amount MOH Pays

2.5830

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R03AL04

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
459 Indefinite

For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).

Note: COPD disease severity is based on spirometry, symptoms and disability (see classification tables below).

Classification

COPD Stages - Symptoms and disability:

Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill.

Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level

Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure

Classification by impairment of lung function:

COPD stage and spirometry (post bronchodilator) FEV1 predicted:

Mild: Greater than or equal to 80 percent

Moderate: 50 to 79 percent

Severe: 30 to 49 percent

Very severe: Less than 30 percent

 

EAP Criteria

NO

Product Monograph

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