RATIO-IPRA SAL UDV SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

IPRATROPIUM BROMIDE; SALBUTAMOL (SALBUTAMOL SULFATE)

Boleh didapati daripada:

TEVA CANADA LIMITED

Kod ATC:

R03AL02

INN (Nama Antarabangsa):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dos:

0.5MG; 2.5MG

Borang farmaseutikal:

SOLUTION

Komposisi:

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

Laluan pentadbiran:

INHALATION

Unit dalam pakej:

2.5 ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-11-28

Ciri produk

PRODUCT MONOGRAPH
Pr
ratio-IPRA SAL UDV
(Ipratropium Bromide Monohydrate and Salbutamol Sulfate)
INHALATION SOLUTION
Each Unit Dose Vial (UDV) contains 0.50 mg of
ipratropium bromide (as ipratropium bromide monohydrate) and 2.5 mg
salbutamol (as
salbutamol sulphate) in 2.5 mL
BRONCHODILATOR
Teva Canada Limited.
Date of Preparation:
30 Novopharm Court July 24, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166253
ratio-IPRA SAL UDV Product Monograph
Page 2 of 38
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
..............................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 12
STORAGE AND STABILITY
.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.................