PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Disponible des:

PALADIN LABS INC.

Codi ATC:

C10BX02

Designació comuna internacional (DCI):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Dosis:

10MG; 81MG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

PRAVASTATIN SODIUM 10MG; ACETYLSALICYLIC ACID 81MG

Vía de administración:

ORAL

Unidades en paquete:

10+10

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2015-07-31

Fitxa tècnica

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
.