M-PRAVASTATIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
23-08-2017
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:
PRAVASTATIN SODIUM
Fáanlegur frá:
MANTRA PHARMA INC
ATC númer:
C10AA03
INN (Alþjóðlegt nafn):
PRAVASTATIN
Skammtar:
20MG
Lyfjaform:
TABLET
Samsetning:
PRAVASTATIN SODIUM 20MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HMG-COA REDUCTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0122563002; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2018-04-19
Vara einkenni
Page 1 of 44
PRODUCT MONOGRAPH
Pr
M-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Mantra Pharma Inc.
Date of Preparation:
4605-B boul. Lapinière, Suite 250
August 15, 2017
Brossard, Quebec
J4Z 3T5
Control# 207352
Page 2 of 44
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................................
3
CONTRAINDICATIONS
..........................................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................................
5
ADVERSE REACTIONS
........................................................................................................................
11
DRUG INTERACTIONS
........................................................................................................................
15
DOSAGE AND ADMINISTRATION
....................................................................................................
17
OVERDOSAGE
.......................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
19
STORAGE AND STABILITY
................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
21
PART II: SCIENTIFIC INFORMATION
...................................................................................................
23
PHARMACEUTICAL INFORMATION
.....
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