ENTROPHEN 325MG CAPLETS TABLET (DELAYED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ACETYLSALICYLIC ACID

Sẵn có từ:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Mã ATC:

N02BA01

INN (Tên quốc tế):

ACETYLSALICYLIC ACID

Liều dùng:

325MG

Dạng dược phẩm:

TABLET (DELAYED-RELEASE)

Thành phần:

ACETYLSALICYLIC ACID 325MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

OTC

Khu trị liệu:

SALICYLATES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0101169001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2002-03-08

Đặc tính sản phẩm

PRODUCT MONOGRAPH
ENTROPHEN
® 325 MG CAPLETS
Acetylsalicylic
Acid Delayed-release Tablets USP
325 mg
ENTROPHEN
® 325 MG TABLETS
Acetylsalicylic
Acid Delayed-release Tablets USP
325 mg
ENTROPHEN
®
Acetylsalicylic
Acid Delayed-release Tablets USP
81 mg
ENTROPHEN
® CHEWABLE
Acetylsalicylic
Acid Tablets USP
81 mg
Analgesic, anti-inflammatory,
antipyretic and
Platelet aggregation inhibitor
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Quebec H4P 2T4
DATE OF REVISION:
November 16, 2021
www.pendopharm.com
SUBMISSION CONTROL NUMBER: 255502 & 255545
®
Registered trademark of Pharmascience Inc.
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................5
WARNINGS AND PRECAUTIONS
.............................................................................5
ADVERSE
REACTIONS..............................................................................................8
DRUG INTERACTIONS
..............................................................................................8
DOSAGE AND ADMINISTRATION
.........................................................................
11
OVERDOSAGE
.........................................................................................................
12
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
13
STORAGE AND STABILITY
....................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
................................................................... 14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 15
PART II : SCIENTIFIC INFOR