TEVA-METOPROLOL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
25-03-2021
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Aktiv bestanddel:
METOPROLOL TARTRATE
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
C07AB02
INN (International Name):
METOPROLOL
Dosering:
50MG
Lægemiddelform:
TABLET
Sammensætning:
METOPROLOL TARTRATE 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500/1000
Recept type:
Prescription
Terapeutisk område:
BETA-ADRENERGIC BLOCKING AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0111923002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2011-01-10
Produktets egenskaber
1
PRODUCT MONOGRAPH
PR
TEVA-METOPROLOL
(METOPROLOL TARTRATE)
25 mg, 50 mg and 100 mg Tablets
USP
β-Adrenergic Receptor Blocking Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
March 1, 2021
Control Number: 244550
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND STABILITY
.........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.........................................................................
26
CLINICAL TRIALS
..........................................................................................................
27
DETAILED PH
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