PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Доступна з:

PALADIN LABS INC.

Код атс:

C10BX02

ІПН (Міжнародна Ім'я):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Дозування:

10MG; 81MG

Фармацевтична форма:

TABLET (DELAYED-RELEASE)

Склад:

PRAVASTATIN SODIUM 10MG; ACETYLSALICYLIC ACID 81MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

10+10

Тип рецепту:

Prescription

Терапевтична области:

HMG-COA REDUCTASE INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2015-07-31

Характеристики продукта

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
.