BISOPROLOL TABLETS

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BISOPROLOL FUMARATE

Disponible des:

SIVEM PHARMACEUTICALS ULC

Codi ATC:

C07AB07

Designació comuna internacional (DCI):

BISOPROLOL

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

BISOPROLOL FUMARATE 10MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

BETA-ADRENERGIC BLOCKING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0122418002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2020-01-14

Fitxa tècnica

_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
.............................................................