ATORVASTATIN-80 TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

C10AA05

INN (International Adı):

ATORVASTATIN

Doz:

80MG

Farmasötik formu:

TABLET

Kompozisyon:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0133055004; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2011-07-27

Ürün özellikleri

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..................................................................................