COMBIVENT RESPIMAT SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

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

Disponibil de la:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Codul ATC:

R03AL02

INN (nume internaţional):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dozare:

20MCG; 100MCG

Forma farmaceutică:

SOLUTION

Compoziție:

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

Calea de administrare:

INHALATION

Unități în pachet:

4ML(120 PUFFS)

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-01-10

Caracteristicilor produsului

_ _
_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