Q-PRAVASTATIN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
31-05-2013
Některé dokumenty pro tento produkt momentálně nejsou k dispozici, můžete poslat požadavek našemu zákaznickému servisu a my vás upozorníme, jakmile je dokážeme získat.
Poslat žádost.
Poslat žádost.
Aktivní složka:
PRAVASTATIN SODIUM
Dostupné s:
QD PHARMACEUTICALS ULC
ATC kód:
C10AA03
INN (Mezinárodní Name):
PRAVASTATIN
Dávkování:
20MG
Léková forma:
TABLET
Složení:
PRAVASTATIN SODIUM 20MG
Podání:
ORAL
Jednotky v balení:
30/100/500
Druh předpisu:
Prescription
Terapeutické oblasti:
HMG-COA REDUCTASE INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0122563002; AHFS:
Stav Autorizace:
CANCELLED PRE MARKET
Datum autorizace:
2015-08-21
Charakteristika produktu
_Page 1 of _
_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
_Page 2 of _
_47_
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
Přečtěte si celý dokument
