DOM-ATORVASTATIN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
13-09-2018

Viambatanisho vya kazi:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Inapatikana kutoka:

DOMINION PHARMACAL

ATC kanuni:

C10AA05

INN (Jina la Kimataifa):

ATORVASTATIN

Kipimo:

40MG

Dawa fomu:

TABLET

Tungo:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

500

Dawa ya aina:

Prescription

Eneo la matibabu:

HMG-COA REDUCTASE INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0133055003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2012-01-10

Tabia za bidhaa

                                _ _
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
...................................
                                
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