APO-NEBIVOLOL TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-09-2019
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ingredients actius:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
Disponible des:
APOTEX INC
Codi ATC:
C07AB12
Designació comuna internacional (DCI):
NEBIVOLOL
Dosis:
2.5MG
formulario farmacéutico:
TABLET
Composición:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) 2.5MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
BETA-ADRENERGIC BLOCKING AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0153531001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2020-12-22
Fitxa tècnica
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
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
..................................................................................................................................
3
WARNINGS AND PRECAUTIONS
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4
ADVERSE REACTIONS
..................................................................................................................................
7
DRUG INTERACTIONS
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11
DOSAGE AND ADMINISTRATION
.............................................................................................................
13
OVERDOSAGE
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14
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................................
15
STORAGE AND
STABILITY.........................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
..
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