RATIO-IPRA SAL UDV SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

IPRATROPIUM BROMIDE; SALBUTAMOL (SALBUTAMOL SULFATE)

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

R03AL02

INN (Algemene Internationale Benaming):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dosering:

0.5MG; 2.5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

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

Toedieningsweg:

INHALATION

Eenheden in pakket:

2.5 ML

Prescription-type:

Prescription

Therapeutisch gebied:

ANTIMUSCARINICS ANTISPASMODICS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2019-11-28

Productkenmerken

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
.................