ATROVENT UDV SOL INH 250MCG/ML SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IPRATROPIUM BROMIDE

Tillgänglig från:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kod:

R03BB01

INN (International namn):

IPRATROPIUM BROMIDE

Dos:

250MCG

Läkemedelsform:

SOLUTION

Sammansättning:

IPRATROPIUM BROMIDE 250MCG

Administreringssätt:

INHALATION

Enheter i paketet:

2 X 10ML

Receptbelagda typ:

Prescription

Terapiområde:

ANTIMUSCARINICS ANTISPASMODICS

Produktsammanfattning:

Active ingredient group (AIG) number: 0115643001; AHFS:

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2008-04-16

Produktens egenskaper

_ _
_Atrovent® UDV Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
ATROVENT
®
UDV
(IPRATROPIUM BROMIDE)
INHALATION SOLUTION
(1 ML AND 2 ML UNIT DOSE VIALS)
EACH PLASTIC UNIT DOSE VIAL (UDV) CONTAINS:
250 MCG OF IPRATROPIUM BROMIDE IN 1 ML
250 MCG OF IPRATROPIUM BROMIDE IN 2 ML
500 MCG OF IPRATROPIUM BROMIDE IN 2 ML
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road,
Burlington, Ontario
L7L 5H4
DATE OF REVISION:
NOVEMBER 01, 2010
SUBMISSION CONTROL NO: 140383
BICL CCDS # 0260-00
_ _
_Atrovent® UDV Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
.........