PRAVASTATIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
27-11-2023
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
PRAVASTATIN SODIUM
Inapatikana kutoka:
SIVEM PHARMACEUTICALS ULC
ATC kanuni:
C10AA03
INN (Jina la Kimataifa):
PRAVASTATIN
Kipimo:
10MG
Dawa fomu:
TABLET
Tungo:
PRAVASTATIN SODIUM 10MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
HMG-COA REDUCTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0122563001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2022-09-21
Tabia za bidhaa
_PRAVASTATIN Product Monograph_
Page 1 of 40
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
pravastatin sodium tablets USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
SIVEM PHARMACEUTICALS ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
CONTROL NUMBER: 280722
DATE OF
PREPARATION:
JUL
23, 2012
DATE
OF
REVISION
NOV 27, 2023
_PRAVASTATIN Product Monograph_
Page 2 of 40
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
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................23
CLINICAL TRIALS
........................................................................................................
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