COMBIVENT RESPIMAT SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE); SALBUTAMOL (SALBUTAMOL SULFATE)

Dostopno od:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Koda artikla:

R03AL02

INN (mednarodno ime):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Odmerek:

20MCG; 100MCG

Farmacevtska oblika:

SOLUTION

Sestava:

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 20MCG; SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Pot uporabe:

INHALATION

Enote v paketu:

4ML(120 PUFFS)

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTIMUSCARINICS ANTISPASMODICS

Povzetek izdelek:

Active ingredient group (AIG) number: 0232902002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2014-01-10

Lastnosti izdelka

_ _
_COMBIVENT RESPIMAT Product Monograph November 7, 2019 _
_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
COMBIVENT
®
RESPIMAT
®
Ipratropium Bromide and Salbutamol
Inhalation Solution
(as Ipratropium Bromide Monohydrate and Salbutamol Sulfate)
Each actuation delivers a dose of 20 mcg of ipratropium bromide
and 100 mcg of salbutamol
COMBIVENT
®
RESPIMAT
®
cartridge for use only with the
COMBIVENT
®
RESPIMAT
®
Inhaler
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Revision:
November 7, 2019
Submission Control No: 230157
Combivent
®
Respimat
®
is a registered trademark used under license by Boehringer Ingelheim
(Canada) Ltd.
CCDS 0204-07
_COMBIVENT RESPIMAT Product Monograph November 7, 2019 _
_Page 2 of 44 _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS