SPIRIVA RESPIMAT SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

Mevcut itibaren:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC kodu:

R03BB04

INN (International Adı):

TIOTROPIUM BROMIDE

Doz:

2.5MCG

Farmasötik formu:

SOLUTION

Kompozisyon:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 2.5MCG

Uygulama yolu:

INHALATION

Paketteki üniteler:

4ML(60 PUFFS OR 28 PUFFS)

Reçete türü:

Prescription

Terapötik alanı:

ANTIMUSCARINICS ANTISPASMODICS

Ürün özeti:

Active ingredient group (AIG) number: 0148683002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-12-17

Ürün özellikleri

_Spiriva_
_®_
_ Respimat_
_®_
_ Product Monograph Page 1 of 41_
PRODUCT MONOGRAPH
Pr
SPIRIVA
®
RESPIMAT
®
Tiotropium (as tiotropium bromide monohydrate)
Inhalation Solution
2.5 mcg per actuation
Bronchodilator
Long-Acting Muscarinic Antagonist (LAMA)
SPIRIVA
®
RESPIMAT
®
cartridge for use only with the SPIRIVA
®
RESPIMAT
®
Inhaler
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario. L7L 5H4
Date of Revision: May 7, 2019
Submission Control No: 224205
BICL # 0269-10
Spiriva
®
and Respimat
®
are registered trademarks of Boehringer Ingelheim International GmbH,
used
under license.
_Spiriva_
_®_
_ 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
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................18
DOSAGE FORMS, COM