IBUPROFEN TABLETS
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
14-10-2016
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Aktiva substanser:
IBUPROFEN
Tillgänglig från:
MARCAN PHARMACEUTICALS INC
ATC-kod:
M01AE01
INN (International namn):
IBUPROFEN
Dos:
200MG
Läkemedelsform:
TABLET
Sammansättning:
IBUPROFEN 200MG
Administreringssätt:
ORAL
Enheter i paketet:
24/500
Receptbelagda typ:
OTC
Terapiområde:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0108883004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2016-10-04
Produktens egenskaper
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
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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
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