BISOPROLOL TABLETS

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BISOPROLOL FUMARATE

Commercializzato da:

SIVEM PHARMACEUTICALS ULC

Codice ATC:

C07AB07

INN (Nome Internazionale):

BISOPROLOL

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

BISOPROLOL FUMARATE 10MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

BETA-ADRENERGIC BLOCKING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-01-14

Scheda tecnica

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