INSPIOLTO RESPIMAT SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE); OLODATEROL (OLODATEROL HYDROCHLORIDE)

Fáanlegur frá:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC númer:

R03AL06

INN (Alþjóðlegt nafn):

OLODATEROL AND TIOTROPIUM BROMIDE

Skammtar:

2.5MCG; 2.5MCG

Lyfjaform:

SOLUTION

Samsetning:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 2.5MCG; OLODATEROL (OLODATEROL HYDROCHLORIDE) 2.5MCG

Stjórnsýsluleið:

INHALATION

Einingar í pakka:

28/60 ACT

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTIMUSCARINICS ANTISPASMODICS

Vörulýsing:

Active ingredient group (AIG) number: 0256970001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2015-05-28

Vara einkenni

_Inspiolto_
_®_
_ Respimat_
_ ®_
_ Product Monograph Page 1 of 50 _
PRODUCT MONOGRAPH PR
INSPIOLTO
® RESPIMAT
®
Tiotropium (as tiotropium bromide monohydrate) and Olodaterol (as
olodaterol hydrochloride)
Inhalation Solution
2.5 mcg/2.5 mcg per actuation
INSPIOLTO
®
RESPIMAT
®
cartridge for use only with the INSPIOLTO
®
RESPIMAT
®
inhaler
Bronchodilator Combination
Long-Acting Muscarinic Antagonist (LAMA) and Long-Acting Beta
2
-Adrenergic Agonist (LABA)
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Revision: November 14, 2019
www.boehringer-ingelheim.ca
Submission Control No: 223910
Inspiolto
®
is a registered trademark of Boehringer Ingelheim International GmbH,
used under license.
Respimat
®
is a registered trademark of Boehringer Ingelheim International GmbH,
used under license.
BICL #: 0287-04
_Inspiolto_
_®_
_ Respimat_
_ ®_
_ Product Monograph Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
9
DRUG INTERACTIONS
..............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 17
STORAGE AN