PRAVASTATIN TABLETS

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PRAVASTATIN SODIUM

Beszerezhető a:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-kód:

C10AA03

INN (nemzetközi neve):

PRAVASTATIN

Adagolás:

10MG

Gyógyszerészeti forma:

TABLET

Összetétel:

PRAVASTATIN SODIUM 10MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0122563001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2009-08-20

Termékjellemzők

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1
PRODUCT MONOGRAPH
Pr
PRAVASTATIN TABLETS
(pravastatin sodium)
TABLETS, 10, 20, AND 40 MG
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario
L4W 0A5
Date of Preparation:
August 17, 2009
CONTROL # 131984
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
……………………………..
3
SUMMARY PRODUCT INFORMATION
……………………………………….
3
INDICATIONS AND CLINICAL USE
……………………………….………
3
CONTRAINDICATIONS
…………………………………………………………
7
WARNINGS AND PRECAUTIONS
……………………………………………..
8
ADVERSE REACTIONS
………………………………………………………..
13
DRUG INTERACTIONS
………………………………………………………..
17
DOSAGE AND ADMINISTRATION
……………………………………………
19
OVERDOSAGE
……………………………………………………………….
21
ACTION AND CLINICAL PHARMACOLOGY
………………………..……....
21
STORAGE AND STABILITY
……………………………………………………
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
……………….……..
24
PART II: SCIENTIFIC INFORMATION
………………………………………………
25
PHARMACEUTICAL INFORMATION
……………………………………..…
25
CLINICAL TRIALS
……………………………………………………………...
25
DETAILED PHARMACOLOGY
…………………………………………………
31
TOXICOLOGY
…………………………………………………………......……..
33
REFERENCES
………………………....…………………………………………
37
PART III: CONSUMER INFORMATION
………………………….…………………
42
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PRODUCT MONOGRAPH
PRAVASTATIN TABLETS
(PRAVASTATIN SODIUM)
Tablets, 10, 20, and 40 mg
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMAR