TORADOL IM 30MG/ML LIQUID

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

KETOROLAC TROMETHAMINE

Διαθέσιμο από:

HOFFMANN-LA ROCHE LIMITED

Φαρμακολογική κατηγορία (ATC):

M01AB15

INN (Διεθνής Όνομα):

KETOROLAC

Δοσολογία:

30MG

Φαρμακοτεχνική μορφή:

LIQUID

Σύνθεση:

KETOROLAC TROMETHAMINE 30MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

1 ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0121995002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2011-01-04

Αρχείο Π.Χ.Π.

_ _
_ _
_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.
_ _
_ _
_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
......................................................................