PMS-DEXAMETHASONE ELIXIR
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
06-06-2022
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Werkstoffen:
DEXAMETHASONE
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
H02AB02
INN (Algemene Internationale Benaming):
DEXAMETHASONE
Dosering:
0.5MG
farmaceutische vorm:
ELIXIR
Samenstelling:
DEXAMETHASONE 0.5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100ML
Prescription-type:
Prescription
Therapeutisch gebied:
ADRENALS
Product samenvatting:
Active ingredient group (AIG) number: 0106303010; AHFS:
Autorisatie-status:
MARKETED
Autorisatie datum:
1992-12-31
Productkenmerken
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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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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
.................
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