COMBIVENT UDV 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:

0.5MG; 2.5MG

Forma farmaceutică:

SOLUTION

Compoziție:

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 0.5MG; SALBUTAMOL (SALBUTAMOL SULFATE) 2.5MG

Calea de administrare:

INHALATION

Unități în pachet:

2.5 X 20ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

Active ingredient group (AIG) number: 0232902001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2020-01-08

Caracteristicilor produsului

_COMBIVENT UDV Product Monograph Draft-Nov 5, 2015 _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
COMBIVENT
® UDV
Ipratropium Bromide (as Monohydrate) and Salbutamol (as Salbutamol
Sulfate)
Nebulizer Solution
Each Unit Dose Vial (UDV) contains 0.50 mg of ipratropium bromide (as
ipratropium bromide
monohydrate) and 2.5 mg salbutamol (as salbutamol sulfate) in 2.5 mL
of saline
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Submission Control No: 186512
CCDS 0204-05
Date of Revision:
November 25, 2015
Combivent
®
is a registered trademark used under license by Boehringer Ingelheim
(Canada) Ltd.
_ _
_ COMBIVENT UDV Product Monograph Draft-Nov 5, 2015 _
_Page 2 of 39 _
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
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22