IBUPROFEN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
04-06-2018
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Aktivní složka:
IBUPROFEN
Dostupné s:
VITA HEALTH PRODUCTS INC
ATC kód:
M01AE01
INN (Mezinárodní Name):
IBUPROFEN
Dávkování:
200MG
Léková forma:
TABLET
Složení:
IBUPROFEN 200MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
OTC
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0108883004; AHFS:
Stav Autorizace:
CANCELLED PRE MARKET
Datum autorizace:
2020-11-23
Charakteristika produktu
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_Page 1 of 45_
PRODUCT MONOGRAPH
IBUPROFEN
Ibuprofen Tablets USP, 200 mg
EXTRA STRENGTH IBUPROFEN
Ibuprofen Tablets USP, 400 mg
Analgesic/Antipyretic
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, Manitoba
Canada, R2J 3W2
Control Number: 214450
Date of Revision:
May 4, 2018
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSRUCTIONS
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
.......................
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