ENTROPHEN TABLET (DELAYED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ACETYLSALICYLIC ACID

Dostupné z:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC kód:

B01AC06

INN (Medzinárodný Name):

ACETYLSALICYLIC ACID

Dávkovanie:

81MG

Forma lieku:

TABLET (DELAYED-RELEASE)

Zloženie:

ACETYLSALICYLIC ACID 81MG

Spôsob podávania:

ORAL

Počet v balení:

12X7

Typ predpisu:

OTC

Terapeutické oblasti:

SALICYLATES

Prehľad produktov:

Active ingredient group (AIG) number: 0101169013; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2006-12-01

Súhrn charakteristických

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