TORADOL INJ 10MG/ML LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

SYNTEX INC.

ATC code:

M01AB15

INN (International Name):

KETOROLAC

Dosage:

10MG

Pharmaceutical form:

LIQUID

Composition:

KETOROLAC TROMETHAMINE 10MG

Administration route:

INTRAMUSCULAR

Units in package:

2 TRAYS OF 5X1ML

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121995001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

1997-08-26

Patient Information leaflet

IMPORTANT: PLEASE READ
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_Page 41 of 44_
PART III: CONSUMER INFORMATION
PR
TORADOL
®
ketorolac tromethamine tablets
PR
TORADOL
® IM
ketorolac tromethamine injection
READ THIS INFORMATION EACH TIME YOU REFILL YOUR PRESCRIPTION IN
CASE NEW INFORMATION HAS BEEN ADDED.
THIS LEAFLET IS PART III OF A THREE-PART "PRODUCT MONOGRAPH"
PUBLISHED WHEN TORADOL WAS APPROVED FOR SALE IN CANADA
AND IS DESIGNED SPECIFICALLY FOR CONSUMERS. THIS LEAFLET IS A
SUMMARY DESIGNED SPECIFICALLY FOR YOU. IT WILL NOT TELL YOU
EVERYTHING ABOUT TORADOL.
See your health care provider and
pharmacist regularly and ask them questions about your health and
any medications you take.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
TORADOL TABLETS
Your health care provider has prescribed TORADOL tablets for
you for one or more of the following medical conditions:

for short-term use as pain relief after surgery, after labour
or after injury causing muscle or joint pain (not to exceed
5 days for post-surgical patients or 7 days for patients
with musculoskeletal pain)
TORADOL INTRAMUSCULAR INJECTION
Your health care provider has prescribed TORADOL IM for you
for one or more of the following medical conditions:

for short-term use in the hospital for pain relief after
surgery (not to exceed 2 days)
WHAT IT DOES:
TORADOL (ketorolac tromethamine), as a non-steroidal anti-
inflammatory drug (NSAID), can reduce the chemicals produced
by your body which cause pain and swelling.
TORADOL, as a non-steroidal anti-inflammatory drug (NSAID),
does NOT cure your illness or prevent it from getting worse.
TORADOL only can relieve pain and reduce swelling as long as
you continue to take it.
WHEN IT SHOULD NOT BE USED:
DO NOT TAKE TORADOL IF YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:

HAVE HAD OR ARE PLANNING TO HAVE HEART BYPASS SURGERY

HAVE SEVERE, UNCONTROLLED HEART FAILURE

HAVE BLEEDING IN THE BRAIN OR OTHER BLEEDING DISORDERS

ARE AT 28 WEEKS OF PREGNANCY OR MORE

ARE IN LABOUR AND DELIVERY

ARE BREASTFEEDING OR PLAN

Summary of Product characteristics

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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 intramuscular injection
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road
Basildon, Essex SS14 3FR
United Kingdom
Distributed by: Methapharm Inc.
Brantford, Ontario N3S 7X6
DATE OF PREPARATION:
NOVEMBER 4, 2015 SUBMISSION CONTROL NO: 187985
TORADOL

is a registered trade-mark of Atnahs Pharma UK Limited, 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
.............................................................