METOPROLOL SR TABLET (EXTENDED-RELEASE)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
17-08-2021
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Aktiv ingrediens:
METOPROLOL TARTRATE
Tilgjengelig fra:
PRO DOC LIMITEE
ATC-kode:
C07AB02
INN (International Name):
METOPROLOL
Dosering :
100MG
Legemiddelform:
TABLET (EXTENDED-RELEASE)
Sammensetning:
METOPROLOL TARTRATE 100MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
BETA-ADRENERGIC BLOCKING AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0111923003; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2023-07-10
Preparatomtale
Page 1 of 45
PRODUCT MONOGRAPH
PR
METOPROLOL
METOPROLOL TARTRATE TABLETS USP
25, 50 & 100 MG
PR
METOPROLOL–L
METOPROLOL TARTRATE TABLETS USP
50 & 100 MG
PR
METOPROLOL SR
PROLONGED-RELEASE METOPROLOL TARTRATE TABLETS MFR STANDARD
100 & 200 MG
Β-ADRENERGIC RECEPTOR BLOCKING AGENT
PRO DOC LTÉE
2925, BOUL. INDUSTRIEL
LAVAL, QUÉBEC
H7L 3W9 DATE OF REVISION: AUGUST 17, 2021
SUBMISSION CONTROL NO.: 254206
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................................
4
CONTRAINDICATIONS
....................................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................................
5
ADVERSE REACTIONS
..................................................................................................................
11
DRUG INTERACTIONS
..................................................................................................................
13
DOSAGE AND ADMINISTRATION
..............................................................................................
17
OVERDOSAGE
.................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.............................................................................
21
STORAGE AND STABILITY
..........................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................
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