IBUPROFEN TABLETS
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
03-04-2020
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Aktiva substanser:
IBUPROFEN
Tillgänglig från:
VITA HEALTH PRODUCTS INC
ATC-kod:
M01AE01
INN (International namn):
IBUPROFEN
Dos:
200MG
Läkemedelsform:
TABLET
Sammansättning:
IBUPROFEN 200MG
Administreringssätt:
ORAL
Enheter i paketet:
500
Receptbelagda typ:
OTC
Terapiområde:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0108883004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2011-05-06
Produktens egenskaper
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_Page 1 of 48_
PRODUCT MONOGRAPH
IBUPROFEN TABLETS
IBUPROFEN CAPLETS
Ibuprofen Tablets USP 200 mg
IBUPROFEN EXTRA STRENGTH CAPLETS
Ibuprofen Tablets USP 400 mg
Analgesic/Antipyretic
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg Manitoba
Canada, R2J 3W2
Control Number: 234885
Date of Revision:
March 12, 2020
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_Page 2 of 48_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
28
TOXICOLOGY
...............
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