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KETOROLAC MEDSURGE, KETOROLAC MEDICIANZ (Medicianz Healthcare Pty Ltd)

Product name
KETOROLAC MEDSURGE, KETOROLAC MEDICIANZ
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
Ketorolac trometamol
Registration type
New generic medicine
Indication

KETOROLAC MEDSURGE, KETOROLAC MEDICIANZ (solution for injection) is indicated for the short-term management of moderately severe, acute pain following surgical procedures. The total duration of ketorolac use should not exceed five days. It is recommended that ketorolac parenteral be used in the immediate post-operative period. Patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the section 4.2 DOSE AND METHOD OF ADMINISTRATION (Refer to Conversion from Parenteral to Oral Therapy). The total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days.

Note that oral dosage forms are available from other brands.

General

KETOROLAC MEDSURGE, KETOROLAC MEDICIANZ solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.

There is no satisfactory evidence for the use of [TRADE NAME] solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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