COMBIVENT UDV SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

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

Beszerezhető a:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kód:

R03AL02

INN (nemzetközi neve):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Adagolás:

0.5MG; 2.5MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

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

Az alkalmazás módja:

INHALATION

db csomag:

2.5 X 20ML

Recept típusa:

Prescription

Terápiás terület:

ANTIMUSCARINICS ANTISPASMODICS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2020-01-08

Termékjellemzők

_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