ATORVASTATIN-80 TABLET
Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
Karakteristik produk
(SPC)
18-05-2010
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Bahan aktif:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
Tersedia dari:
PRO DOC LIMITEE
Kode ATC:
C10AA05
INN (Nama Internasional):
ATORVASTATIN
Dosis:
80MG
Bentuk farmasi:
TABLET
Komposisi:
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG
Rute administrasi :
ORAL
Unit dalam paket:
30/100
Jenis Resep:
Prescription
Area terapi:
HMG-COA REDUCTASE INHIBITORS
Ringkasan produk:
Active ingredient group (AIG) number: 0133055004; AHFS:
Status otorisasi:
CANCELLED POST MARKET
Tanggal Otorisasi:
2011-07-27
Karakteristik produk
Page 1 of 48
PRODUCT MONOGRAPH
Pr
ATORVASTATIN – 10
Pr
ATORVASTATIN – 20
Pr
ATORVASTATIN – 40
Pr
ATORVASTATIN – 80
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF PREPARATION:
2925, BOUL. INDUSTRIEL
MAY 18, 2010
LAVAL, QUÉBEC
H7L 3W9
SUBMISSION CONTROL NO: 137958
Page 2 of 48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................3
SUMMARY PRODUCT
INFORMATION.................................................................................3
INDICATIONS AND CLINICAL
USE.......................................................................................3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND
PRECAUTIONS.........................................................................................5
ADVERSE REACTIONS
.......................................................................................................10
DRUG
INTERACTIONS........................................................................................................11
DOSAGE AND
ADMINISTRATION.......................................................................................15
OVERDOSAGE.....................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................17
STORAGE AND STABILITY
.................................................................................................20
SPECIAL HANDLING
INSTRUCTIONS................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................20
PART II: SCIENTIFIC
INFORMATION..................................................................................
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