PRAVASTATIN TABLETS

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PRAVASTATIN SODIUM

Disponible depuis:

RANBAXY PHARMACEUTICALS CANADA INC.

Code ATC:

C10AA03

DCI (Dénomination commune internationale):

PRAVASTATIN

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

PRAVASTATIN SODIUM 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-08-20

Résumé des caractéristiques du produit

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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