IBUPROFEN EXTRA STRENGTH CAPLETS TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

IBUPROFEN

זמין מ:

MARCAN PHARMACEUTICALS INC

קוד ATC:

M01AE01

INN (שם בינלאומי):

IBUPROFEN

כמות:

400MG

טופס פרצבטיות:

TABLET

הרכב:

IBUPROFEN 400MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

16/300

סוג מרשם:

OTC

איזור תרפויטי:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0108883002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2016-10-04

מאפייני מוצר

1
PRODUCT MONOGRAPH
IBUPROFEN TABLETS
IBUPROFEN CAPLETS
Ibuprofen Tablets USP 200 mg
IBUPROFEN EXTRA STRENGTH CAPLETS
Ibuprofen Tablets USP 400 mg
Analgesic/Antipyretic
Date of revision:
October 4, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit #4
Ottawa, Ontario
K2E 7Z7
Control# 197472
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
5
ADVERSE REACTIONS
.......................................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................................
13
DOSAGE AND ADMINISTRATION:
..................................................................................................
17
OVERDOSE
...........................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
18
STABILITY AND STORAGE
...............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 21
PART II: SCIENTIFIC INFORMATIO