PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Beschikbaar vanaf:

PALADIN LABS INC.

ATC-code:

C10BX02

INN (Algemene Internationale Benaming):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Dosering:

10MG; 81MG

farmaceutische vorm:

TABLET (DELAYED-RELEASE)

Samenstelling:

PRAVASTATIN SODIUM 10MG; ACETYLSALICYLIC ACID 81MG

Toedieningsweg:

ORAL

Eenheden in pakket:

10+10

Prescription-type:

Prescription

Therapeutisch gebied:

HMG-COA REDUCTASE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0251548001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2015-07-31

Productkenmerken

1
PRODUCT MONOGRAPH
PR PAL-PRAVASTATIN-ASA
Acetylsalicylic acid delayed-release tablets/caplets USP
81 mg,162 mg and 325 mg
and
Pravastatin sodium tablets
10 mg, 20 mg and 40 mg
PLATELET AGGREGATION INHIBITOR
AND
LIPID METABOLISM REGULATOR
Paladin Labs Inc.
Date of Revision:
6111 Royalmount Ave. Suite #102
September 19, 2012
Montreal, Quebec
H4P 2T4
Control No. 158368
_ _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
4
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
12
DRUG INTERACTIONS
..........................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
..................................................................................
26
CLINICAL TRIALS
.