AG-NIFEDIPINE ER TABLET (EXTENDED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
21-01-2021
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Aktiva substanser:
NIFEDIPINE
Tillgänglig från:
ANGITA PHARMA INC.
ATC-kod:
C08CA05
INN (International namn):
NIFEDIPINE
Dos:
60MG
Läkemedelsform:
TABLET (EXTENDED-RELEASE)
Sammansättning:
NIFEDIPINE 60MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
DIHYDROPYRIDINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0115253005; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2021-01-27
Produktens egenskaper
AG-Nifedipine ER
1
PRODUCT MONOGRAPH
PR
AG-NIFEDIPINE ER
Nifedipine Extended Release Tablets USP
60 mg
Antianginal/Antihypertensive Agent
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision:
January 21, 2021
Submission Control No.: 247279
AG-Nifedipine ER
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSION-AL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
8
DRUG INTERACTIONS
...............................................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................................
17
OVERDOSAGE
..............................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
18
STORAGE AND STABILITY
.......................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 21
PART II: SCIENTIFIC INFORMATION
.......................................................................................
23
PHARMACEUTICAL INFORMATION
.....................................................................................
23
CLINICAL TRIALS
......................
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