PRAVASTATIN TABLETS

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

PRAVASTATIN SODIUM

Fáanlegur frá:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC númer:

C10AA03

INN (Alþjóðlegt nafn):

PRAVASTATIN

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

PRAVASTATIN SODIUM 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HMG-COA REDUCTASE INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0122563003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2009-08-20

Vara einkenni

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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