DOM-ATORVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Saatavilla:

DOMINION PHARMACAL

ATC-koodi:

C10AA05

INN (Kansainvälinen yleisnimi):

ATORVASTATIN

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Antoreitti:

ORAL

Kpl paketissa:

500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0133055001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2012-01-10

Valmisteyhteenveto

_ _
PRODUCT MONOGRAPH
PR
DOM-ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
DOMINION PHARMACAL
Date of Revision:
6111 Royalmount Ave., Suite #100
September 13, 2018
Montréal, Québec
H4P 2T4
Submission Control No.: 219990
_Dom-ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
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
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
...................................