Country: Kanada
Tungumál: enska
Heimild: Health Canada
BISOPROLOL FUMARATE
SIVEM PHARMACEUTICALS ULC
C07AB07
BISOPROLOL
10MG
TABLET
BISOPROLOL FUMARATE 10MG
ORAL
15G/50G
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0122418002; AHFS:
APPROVED
2020-01-14
_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 ............................................................. Lestu allt skjalið