BISOPROLOL TABLETS
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-10-2022
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Aktiv bestanddel:
BISOPROLOL FUMARATE
Tilgængelig fra:
SIVEM PHARMACEUTICALS ULC
ATC-kode:
C07AB07
INN (International Name):
BISOPROLOL
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
BISOPROLOL FUMARATE 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Terapeutisk område:
BETA-ADRENERGIC BLOCKING AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0122418002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2020-01-14
Produktets egenskaber
_BISOPROLOL TABLETS _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BISOPROLOL TABLETS
Bisoprolol fumarate tablets
5 mg, 10 mg tablets (oral)
Manufacturer’s Standard
β-adrenoceptor blocking agent
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control No: 267679
Date of
Revision:
OCT
24, 2022
_BISOPROLOL TABLETS _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
21
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.............................................................
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