ATROVENT HFA METERED-DOSE AEROSOL

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:

20MCG

Bentuk farmasi:

METERED-DOSE AEROSOL

Komposisi:

IPRATROPIUM BROMIDE 20MCG

Rute administrasi :

INHALATION

Unit dalam paket:

200 METERED DOSES

Jenis Resep:

Prescription

Area terapi:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

Active ingredient group (AIG) number: 0115643002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-07-02

Karakteristik produk

_ _
Atrovent HFA Product Monograph November 4, 2019
Page 1 of 30
PRODUCT MONOGRAPH
PR
ATROVENT
® HFA
(IPRATROPIUM BROMIDE)
PRESSURIZED INHALATION SOLUTION
20 MCG/METERED DOSE
BRONCHODILATOR
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road,
Burlington, Ontario
L7L 5H4
Date of Revision:
November 4, 2019
Submission Control No: 230291
BICL-CCDS No. 0260-02
_ _
Atrovent HFA Product Monograph November 4, 2019
Page 2 of 30
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
.............................................