PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Dostupné z:

PALADIN LABS INC.

ATC kód:

C10BX02

INN (Medzinárodný Name):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Dávkovanie:

20MG; 81MG

Forma lieku:

TABLET (DELAYED-RELEASE)

Zloženie:

PRAVASTATIN SODIUM 20MG; ACETYLSALICYLIC ACID 81MG

Spôsob podávania:

ORAL

Počet v balení:

10+10

Typ predpisu:

Prescription

Terapeutické oblasti:

HMG-COA REDUCTASE INHIBITORS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2015-07-31

Súhrn charakteristických

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
.