GenRx

Main information

  • Trade name:
  • GenRx KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GenRx KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217076
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217076

GenRx KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/10/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. GenRx KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

31/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ketorolac 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 an oral formulation

(dependent on their analgesic needs), as outlined in the Dosage and Administration Section (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.

General

Ketorolac 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 of the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and fetal

circulation. There is no satisfactory evidence for the use of ketorolac in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid

or osteoarthritis).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

Components

1. GenRx KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Visual Identification

A clear and slightly yellow coloured solution.

Active Ingredients

Ketorolac trometamol

10 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:59:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information