LESCOL XL TABLET (EXTENDED-RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
24-06-2019
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:
FLUVASTATIN (FLUVASTATIN SODIUM)
Inapatikana kutoka:
NOVARTIS PHARMACEUTICALS CANADA INC
ATC kanuni:
C10AA04
INN (Jina la Kimataifa):
FLUVASTATIN
Kipimo:
80MG
Dawa fomu:
TABLET (EXTENDED-RELEASE)
Tungo:
FLUVASTATIN (FLUVASTATIN SODIUM) 80MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
28
Dawa ya aina:
Prescription
Eneo la matibabu:
HMG-COA REDUCTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0125247003; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2021-06-14
Tabia za bidhaa
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LESCOL
®
XL
Fluvastatin sodium
Extended release tablets
80 mg
Lipid Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec, H9S 1A9
DATE OF REVISION:
June 24, 2019
SUBMISSION CONTROL NUMBER: 226973
LESCOL is a registered trademark
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................5
WARNINGS AND PRECAUTIONS
...............................................................................6
ADVERSE REACTIONS
................................................................................................17
DRUG INTERACTIONS
................................................................................................22
DOSAGE AND ADMINISTRATION
...........................................................................28
ACTION AND CLINICAL PHARMACOLOGY
........................................................32
STORAGE AND
STABILITY........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
....................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................38
PHARMACEUTICAL INFORMATION
......................................................................38
CLINICAL TRIALS
........................................................................................................39
DETAILED PHARMACOLOGY
..................................................................................48
M
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