INSPIOLTO RESPIMAT SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

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

Saadav alates:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC kood:

R03AL06

INN (Rahvusvaheline Nimetus):

OLODATEROL AND TIOTROPIUM BROMIDE

Annus:

2.5MCG; 2.5MCG

Ravimvorm:

SOLUTION

Koostis:

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

Manustamisviis:

INHALATION

Ühikuid pakis:

28/60 ACT

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTIMUSCARINICS ANTISPASMODICS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2015-05-28

Toote omadused

_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