ENTROPHEN 325MG TABLETS TABLET (DELAYED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ACETYLSALICYLIC ACID

Dostępny od:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kod ATC:

N02BA01

INN (International Nazwa):

ACETYLSALICYLIC ACID

Dawkowanie:

325MG

Forma farmaceutyczna:

TABLET (DELAYED-RELEASE)

Skład:

ACETYLSALICYLIC ACID 325MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

OTC

Dziedzina terapeutyczna:

SALICYLATES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2002-03-08

Charakterystyka produktu

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