PRAVASTATIN TABLETS

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

PRAVASTATIN SODIUM

Inapatikana kutoka:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kanuni:

C10AA03

INN (Jina la Kimataifa):

PRAVASTATIN

Kipimo:

40MG

Dawa fomu:

TABLET

Tungo:

PRAVASTATIN SODIUM 40MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

HMG-COA REDUCTASE INHIBITORS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2009-08-20

Tabia za bidhaa

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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