PMS-DEXAMETHASONE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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Fachinformation Fachinformation (SPC)
26-09-2023

Wirkstoff:

DEXAMETHASONE

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

H02AB02

INN (Internationale Bezeichnung):

DEXAMETHASONE

Dosierung:

2MG

Darreichungsform:

TABLET

Zusammensetzung:

DEXAMETHASONE 2MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100TAB

Verschreibungstyp:

Prescription

Therapiebereich:

ADRENALS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0106303002; AHFS:

Berechtigungsstatus:

MARKETED

Berechtigungsdatum:

2006-06-08

Fachinformation

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_pms-DEXAMETHASONE _
_Page 1 of 32_
PRESCRIBING INFORMATION
PR
PMS-DEXAMETHASONE
Dexamethasone Tablets, USP
0.5 mg, 0.75 mg, 2 mg, 4 mg
Corticosteroid
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Revision:
September 26, 2023
Submission Control Number: 273378
_ _
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_pms-DEXAMETHASONE _
_Page 2 of 32_
TABLE OF CONTENTS
1
INDICATIONS
...............................................................................................................
3
2
CONTRAINDICATIONS
.................................................................................................
4
3
DOSAGE AND ADMINISTRATION
.................................................................................
5
4
OVERDOSAGE
..............................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................. 8
6
WARNINGS AND PRECAUTIONS
..................................................................................
9
6.1
Special
Populations...............................................................................................
15
6.1.1
Pregnant Women
...........................................................................................
15
6.1.2
Breast-feeding
................................................................................................
16
6.1.3
Pediatrics
........................................................................................................
16
6.1.4
Geriatrics
........................................................................................................
16
7
ADVERSE REACTIONS
................................................................................................
17
8
DRUG INTERACTIONS
................................................................................................
19
9
CLINICAL PHARMACOLOGY
.......................................................................................
21
10
STORAGE, STABILITY AND 
                                
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