SANDOZ SALBUTAMOL SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SALBUTAMOL (SALBUTAMOL SULFATE)

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

R03AC02

INN (Internationale Bezeichnung):

SALBUTAMOL

Dosierung:

5MG

Darreichungsform:

SOLUTION

Zusammensetzung:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Verabreichungsweg:

INHALATION

Einheiten im Paket:

10ML(5MG/ML)

Verschreibungstyp:

Prescription

Therapiebereich:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2017-05-25

Fachinformation

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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
_ _
_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
...........