देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
KETOROLAC TROMETHAMINE
SYNTEX INC.
M01AB15
KETOROLAC
10MG
LIQUID
KETOROLAC TROMETHAMINE 10MG
INTRAMUSCULAR
2 TRAYS OF 5X1ML
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995001; AHFS:
CANCELLED POST MARKET
1997-08-26
IMPORTANT: PLEASE READ _ _ _ _ _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 पूरा दस्तावेज़ पढ़ें
_ _ _ _ _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. _ _ _ _ _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 ............................................................. पूरा दस्तावेज़ पढ़ें