APO-NEBIVOLOL TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)

Boleh didapati daripada:

APOTEX INC

Kod ATC:

C07AB12

INN (Nama Antarabangsa):

NEBIVOLOL

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

BETA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0153531001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-12-22

Ciri produk

Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-NEBIVOLOL
Nebivolol Tablets
2.5 mg, 5 mg and 20 mg Nebivolol
(as nebivolol hydrochloride)
Antihypertensive Agent
APOTEX INC.
Date of Preparation:
150 Signet Drive
September 23, 2019
Toronto, Ontario
M9L 1T9
Submission Control No: 223530
Page 2 of 34
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
..................................................................................................................................
7
DRUG INTERACTIONS
.................................................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................................................
13
OVERDOSAGE
...............................................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................................
15
STORAGE AND
STABILITY.........................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
..