Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ketorolac trometamol, Quantity: 30 mg/mL
Baxter Healthcare Pty Ltd
Ketorolac trometamol
Injection, solution
Excipient Ingredients: ethanol; sodium hydroxide; hydrochloric acid; nitrogen; water for injections; sodium chloride
Intramuscular
25 ampoule, 10 ampoule, 5 ampoule
(S4) Prescription Only Medicine
Ketorolac-Baxter 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 section 4.2 Dose and method of administration (Refer to "Conversion from Intramuscular 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-Baxter 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 Ketorolac-Baxter in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).
Visual Identification: Clear slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-12-19
KETOROLAC-CLARIS KETOROLAC TROMETAMOL 10 MG/1 ML AND 30 MG/1 ML, SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ketorolac-Claris injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Ketorolac-Claris injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KETOROLAC-CLARIS IS USED FOR Ketorolac trometamol belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Ketorolac-Claris relieves pain and reduces inflammation (swelling and soreness) that may occur following surgery. Although Ketorolac-Claris can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor may have prescribed Ketorolac-Claris for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY KETOROLAC-CLARIS HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Ketorolac-Claris is not addictive BEFORE YOU ARE GIVEN KETOROLAC-CLARIS _WHEN YOU MUST NOT BE GIVEN IT _ YOU SHOULD NOT BE GIVEN KETOROLAC-CLARIS IF: 1. YOU HAVE AN ALLERGY TO: • KETOROLAC TROMETAMOL OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET • ASPIRIN OR ANY OTHER NSAID MEDICINE Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist. Symptoms of an allergic reaction to these medicines may include: • asthma, wheezing or shortness of breath • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing • hives, itching or skin rash • fainting If you are allergic to aspirin or NSAID medi Read the complete document
Keterolac-Baxter (Ketorolac Trometamol) Version 1.0 1 of 19 AUSTRALIAN PRODUCT INFORMATION KETOROLAC-BAXTER (KETOROLAC TROMETAMOL) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ketorolac trometamol (synonym ketorolac tromethamine 10 mg/mL and 30 mg/mL, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients with known effect: • Contains Ethanol ~12.3%v/v For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ketorolac-Baxter 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. _ WARNING Ketorolac-Baxter is a potent NSAID analgesic and the resulting NSAID-related adverse effects can be serious, for example gastrointestinal haemorrhage, surgical haemorrhage and renal impairment. Increasing the dose of Ketorolac-Baxter beyond the recommendations in the product information will not provide better efficacy but will result in increasing risk of developing serious adverse effects. Keterolac-Baxter (Ketorolac Trometamol) Version 1.0 2 of 19 GENERAL Ketorolac-Baxter 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 Ketorolac-Baxter in acute exacer Read the complete document