PMS-DEXAMETHASONE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
26-09-2023
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Aktiv ingrediens:
DEXAMETHASONE
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
H02AB02
INN (International Name):
DEXAMETHASONE
Dosering :
2MG
Legemiddelform:
TABLET
Sammensetning:
DEXAMETHASONE 2MG
Administreringsrute:
ORAL
Enheter i pakken:
100TAB
Resept typen:
Prescription
Terapeutisk område:
ADRENALS
Produkt oppsummering:
Active ingredient group (AIG) number: 0106303002; AHFS:
Autorisasjon status:
MARKETED
Autorisasjon dato:
2006-06-08
Preparatomtale
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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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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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