PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Boleh didapati daripada:

PALADIN LABS INC.

Kod ATC:

C10BX02

INN (Nama Antarabangsa):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Dos:

20MG; 81MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

PRAVASTATIN SODIUM 20MG; ACETYLSALICYLIC ACID 81MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

10+10

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0251548002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2015-07-31

Ciri produk

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
.