PMS-DEXAMETHASONE ELIXIR

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DEXAMETHASONE

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

H02AB02

INN (Internationale Bezeichnung):

DEXAMETHASONE

Dosierung:

0.5MG

Darreichungsform:

ELIXIR

Zusammensetzung:

DEXAMETHASONE 0.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100ML

Verschreibungstyp:

Prescription

Therapiebereich:

ADRENALS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0106303010; AHFS:

Berechtigungsstatus:

MARKETED

Berechtigungsdatum:

1992-12-31

Fachinformation

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_pms-DEXAMETHASONE ELIXIR _
_Page 1 of 31_
PRESCRIBING INFORMATION
PR
PMS-DEXAMETHASONE ELIXIR
Dexamethasone Elixir, USP
0.5 mg / 5 mL
Corticosteroid
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Revision:
June 06, 2022
Submission Control Number: 259974
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_pms-DEXAMETHASONE ELIXIR _
_Page 2 of 31_
TABLE OF CONTENTS
1
INDICATIONS
..............................................................................................................
3
2
CONTRAINDICATIONS
.................................................................................................
4
3
DOSAGE AND
ADMINISTRATION.................................................................................
5
4
OVERDOSAGE
.............................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................. 7
6
WARNINGS AND PRECAUTIONS
..................................................................................
8
6.1
Special Populations
..........................................................................................
14
6.1.1
Pregnant Women
.......................................................................................
14
6.1.2
Breast-feeding............................................................................................
15
6.1.3
Pediatrics
...................................................................................................
15
6.1.4
Geriatrics
...................................................................................................
15
7
ADVERSE REACTIONS
................................................................................................
16
8
DRUG
INTERACTIONS................................................................................................
18
9
CLINICAL PHARMACOLOGY
.......................................................................................
20
10
STORAGE, STABILITY AND DISPOSAL
.................