PMS-IPRATROPIUM SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IPRATROPIUM BROMIDE

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

R03BB01

INN (Nama Internasional):

IPRATROPIUM BROMIDE

Dosis:

250MCG

Bentuk farmasi:

SOLUTION

Komposisi:

IPRATROPIUM BROMIDE 250MCG

Rute administrasi :

INHALATION

Unit dalam paket:

1ML

Jenis Resep:

Prescription

Area terapi:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1997-04-25

Karakteristik produk

_pms-IPRATROPIUM Product Monograph Page 1 of 28_
PRODUCT MONOGRAPH
PR
PMS-IPRATROPIUM
Ipratropium Bromide Inhalation Solution
125 mcg/mL & 250 mcg/mL
BRONCHODILATOR
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montreal, Quebec H4P 2T4
www.pharmascience.com
Date of Revision:
April 12, 2017
Control No: 197460
_pms-IPRATROPIUM Product Monograph Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSDTUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS
................