PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Mevcut itibaren:

PALADIN LABS INC.

ATC kodu:

C10BX02

INN (International Adı):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Doz:

20MG; 81MG

Farmasötik formu:

TABLET (DELAYED-RELEASE)

Kompozisyon:

PRAVASTATIN SODIUM 20MG; ACETYLSALICYLIC ACID 81MG

Uygulama yolu:

ORAL

Paketteki üniteler:

10+10

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2015-07-31

Ürün özellikleri

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
.