APO-NEBIVOLOL TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
23-09-2019
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Aktívna zložka:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
Dostupné z:
APOTEX INC
ATC kód:
C07AB12
INN (Medzinárodný Name):
NEBIVOLOL
Dávkovanie:
5MG
Forma lieku:
TABLET
Zloženie:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) 5MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
BETA-ADRENERGIC BLOCKING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0153531002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2020-12-22
Súhrn charakteristických
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
..
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