ATORVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступно од:

RANBAXY PHARMACEUTICALS CANADA INC.

АТЦ код:

C10AA05

INN (Међународно име):

ATORVASTATIN

Дозирање:

80MG

Фармацеутски облик:

TABLET

Састав:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Пут администрације:

ORAL

Јединице у пакету:

90/500

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2014-12-19

Карактеристике производа

_ _
_ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, ON
L4W 0A5
Date of Preparation:
December 8, 2014
Submission Control No: 179960
_ _
_ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph _
_Page 2 of 50_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
.............