AG-NIFEDIPINE ER TABLET (EXTENDED-RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
21-01-2021
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
NIFEDIPINE
Fáanlegur frá:
ANGITA PHARMA INC.
ATC númer:
C08CA05
INN (Alþjóðlegt nafn):
NIFEDIPINE
Skammtar:
60MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
NIFEDIPINE 60MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
DIHYDROPYRIDINES
Vörulýsing:
Active ingredient group (AIG) number: 0115253005; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-01-27
Vara einkenni
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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