NIFEDIPINE ER TABLET (EXTENDED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
27-02-2019

Aktiv bestanddel:

NIFEDIPINE

Tilgængelig fra:

PRO DOC LIMITEE

ATC-kode:

C08CA05

INN (International Name):

NIFEDIPINE

Dosering:

60MG

Lægemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensætning:

NIFEDIPINE 60MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100

Recept type:

Prescription

Terapeutisk område:

DIHYDROPYRIDINES

Produkt oversigt:

Active ingredient group (AIG) number: 0115253005; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2014-03-18

Produktets egenskaber

                                PRODUCT MONOGRAPH
PR
NIFEDIPINE ER
Nifedipine Extended-Release Tablets, House Standard
20 mg, 30 mg and 60 mg Nifedipine
Antianginal/Antihypertensive Agent
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
February 27, 2019
Submission Control No.: 224326
_ _
_NIFEDIPINE ER Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMACOLOGY
....................
                                
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Produktets egenskaber Produktets egenskaber fransk 27-02-2019

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