PRAVASTATIN TABLETS

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PRAVASTATIN SODIUM

Pieejams no:

RANBAXY PHARMACEUTICALS CANADA INC.

ATĶ kods:

C10AA03

SNN (starptautisko nepatentēto nosaukumu):

PRAVASTATIN

Deva:

40MG

Zāļu forma:

TABLET

Kompozīcija:

PRAVASTATIN SODIUM 40MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

HMG-COA REDUCTASE INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2009-08-20

Produkta apraksts

_ _
_ _
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
_ _
_ _
2
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
_ _
_ _
3
PRODUCT MONOGRAPH
PRAVASTATIN TABLETS
(PRAVASTATIN SODIUM)
Tablets, 10, 20, and 40 mg
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMAR