TORADOL IM 30MG/ML LIQUID
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
28-11-2014
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Aktiva substanser:
KETOROLAC TROMETHAMINE
Tillgänglig från:
HOFFMANN-LA ROCHE LIMITED
ATC-kod:
M01AB15
INN (International namn):
KETOROLAC
Dos:
30MG
Läkemedelsform:
LIQUID
Sammansättning:
KETOROLAC TROMETHAMINE 30MG
Administreringssätt:
INTRAMUSCULAR
Enheter i paketet:
1 ML
Receptbelagda typ:
Prescription
Terapiområde:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0121995002; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2011-01-04
Produktens egenskaper
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_Page 1 of 44_
PRODUCT MONOGRAPH
PR
TORADOL
®
ketorolac tromethamine
10 mg tablets
PR
TORADOL
® IM
ketorolac tromethamine injection
10 mg/mL or 30 mg/mL intramuscular injection
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Date of Revision:
November 25, 2014
Copyright 1990-2014 by Hoffmann-La Roche Ltd.
Submission Control No: 176089
TORADOL is a registered trade-mark of F. Hoffmann-La Roche AG, used
under license.
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_Page 2 of 44_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................28
DETAILED PHARMACOLOGY
.....................................................................................28
TOXICOLOGY
......................................................................
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