STRIVERDI RESPIMAT SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLODATEROL (OLODATEROL HYDROCHLORIDE)

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

R03AC19

INN (International Name):

OLODATEROL

Dosage:

2.5MCG

Pharmaceutical form:

SOLUTION

Composition:

OLODATEROL (OLODATEROL HYDROCHLORIDE) 2.5MCG

Administration route:

INHALATION

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0154370001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-11-10

Summary of Product characteristics

_ _
_Striverdi_
_®_
_ Respimat_
_®_
_ Product Monograph _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH PR
STRIVERDI
® RESPIMAT
®
Olodaterol Hydrochloride Inhalation Solution,
2.5 mcg Olodaterol/Actuation (as olodaterol hydrochloride)
STRIVERDI
®
RESPIMAT
®
cartridge for use only with the STRIVERDI
®
RESPIMAT
®
inhaler
Long-acting beta
2
-agonist
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Preparation:
May 13, 2019
www.boehringer-ingelheim.ca
Submission Control No: 224290
Striverdi
®
and Respimat
®
are registered trademarks and used under license from Boehringer
Ingelheim
International GmbH
BICL #: 0270-04
_ _
_Striverdi_
_®_
_ Respimat_
_®_
_ Product Monograph _
_ _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.................................