SANDOZ SALBUTAMOL SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

SALBUTAMOL (SALBUTAMOL SULFATE)

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

R03AC02

INN (Algemene Internationale Benaming):

SALBUTAMOL

Dosering:

5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Toedieningsweg:

INHALATION

Eenheden in pakket:

10ML(5MG/ML)

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0108887006; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2017-05-25

Productkenmerken

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PRODUCT MONOGRAPH
PR
SANDOZ SALBUTAMOL
(salbutamol sulfate inhalation solution)
0.5%
5 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
SANDOZ CANADA INC.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision:
May 17, 2017
Submission Control No: 205188
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_Sandoz Salbutanol 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
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 13
PART II: SCIENTIFIC INFORMATION
...............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
..........................................................................................................
15
DETAILED PHARMACOLOGY
...........