COMBIVENT UDV SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

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

から入手可能:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATCコード:

R03AL02

INN（国際名）:

SALBUTAMOL AND IPRATROPIUM BROMIDE

投薬量:

0.5MG; 2.5MG

医薬品形態:

SOLUTION

構図:

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

投与経路:

INHALATION

パッケージ内のユニット:

2.5 X 20ML

処方タイプ:

Prescription

治療領域:

ANTIMUSCARINICS ANTISPASMODICS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2020-01-08

製品の特徴

_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