ATROVENT UDV SOL INH 250MCG/ML SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IPRATROPIUM BROMIDE

Tersedia dari:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Kode ATC:

R03BB01

INN (Nama Internasional):

IPRATROPIUM BROMIDE

Dosis:

250MCG

Bentuk farmasi:

SOLUTION

Komposisi:

IPRATROPIUM BROMIDE 250MCG

Rute administrasi :

INHALATION

Unit dalam paket:

2 X 10ML

Jenis Resep:

Prescription

Area terapi:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2008-04-16

Karakteristik produk

_ _
_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
.........