SANDOZ PRAVASTATIN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
16-02-2017
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:
SANDOZ CANADA INCORPORATED
ATC númer:
C10AA03
INN (Alþjóðlegt nafn):
PRAVASTATIN
Skammtar:
20MG
Lyfjaform:
TABLET
Samsetning:
PRAVASTATIN SODIUM 20MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/250/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HMG-COA REDUCTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0122563002; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2017-05-29
Vara einkenni
PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
Page 2 of 41
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
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
............................................................................................................
Lestu allt skjalið
