Q-PRAVASTATIN TABLET
Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
31-05-2013
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
PRAVASTATIN SODIUM
Disponibbli minn:
QD PHARMACEUTICALS ULC
Kodiċi ATC:
C10AA03
INN (Isem Internazzjonali):
PRAVASTATIN
Dożaġġ:
40MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
PRAVASTATIN SODIUM 40MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
30/100
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
HMG-COA REDUCTASE INHIBITORS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0122563003; AHFS:
L-istatus ta 'awtorizzazzjoni:
CANCELLED PRE MARKET
Data ta 'l-awtorizzazzjoni:
2015-08-21
Karatteristiċi tal-prodott
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_47_
PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32
Aqra d-dokument sħiħ
