TEVA-PRAVASTATIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
14-07-2020
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Aktivna sestavina:
PRAVASTATIN SODIUM
Dostopno od:
TEVA CANADA LIMITED
Koda artikla:
C10AA03
INN (mednarodno ime):
PRAVASTATIN
Odmerek:
20MG
Farmacevtska oblika:
TABLET
Sestava:
PRAVASTATIN SODIUM 20MG
Pot uporabe:
ORAL
Enote v paketu:
30/100
Tip zastaranja:
Prescription
Terapevtsko območje:
HMG-COA REDUCTASE INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0122563002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2003-01-08
Lastnosti izdelka
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PRAVASTATIN
pravastatin sodium
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2020
Toronto, Ontario
Canada M1B 2K9
SUBMISSION CONTROL NO:
240026
_ _
2
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
...........................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.................................................
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