Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
ketorolac trometamol, Quantity: 10 mg
Medsurge Pharma Pty Ltd
Injection
Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections; hydrochloric acid; ethanol
Intramuscular
5 x 1 mL ampoules
(S4) Prescription Only Medicine
KETOROLAC MEDSURGE 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 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 KETOROLAC MEDSURGE solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).
Visual Identification: A clear and slightly yellow coloured solution free from visible particulate.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2022-06-08
Ketorolac Medsurge CMI 1 KETOROLAC MEDSURGE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING KETOROLAC MEDSURGE? Ketorolac Medsurge contains the active ingredient ketorolac trometamol. Ketorolac Medsurge is used to relieve pain and reduce inflammation (swelling and soreness) that may occur following surgery. For more information, see Section 1. Why am I using Ketorolac Medsurge? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE KETOROLAC MEDSURGE? Do not use if you have ever had an allergic reaction to Ketorolac Medsurge or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING . For more information, see Section 2. What should I know before I use Ketorolac Medsurge? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ketorolac Medsurge and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE KETOROLAC MEDSURGE? • Ketorolac Medsurge is given as an injection, into a muscle by a doctor or trained nurse. • The usual dose for healthy adults is 10 mg to 30 mg every 4 to 6 hours, up to a maximum daily dose of 90 mg. More instructions can be found in Section 4. How do I use Ketorolac Medsurge? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING KETOROLAC MEDSURGE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Ketorolac Medsurge. • Tell your doctor you are being given Ketorolac Medsurge if you are going to have surgery. • Tell your doctor, if you get an infection soon after receiving Ketorolac Medsurge. Signs of an infection may include fever, pain, swelling and redness. THINGS YOU SHOULD NOT DO • Do not receive Ketorolac Medsurge for longer than 5 days. Pr Lestu allt skjalið
KETOROLAC PRODUCT INFORMATION WARNING KETOROLAC MEDSURGE solution for injection 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 MEDSURGE solution for injection beyond the recommendations in the product information will not provide better efficacy but will result in increasing risk of developing serious adverse effects. AUSTRALIAN PRODUCT INFORMATION- KETOROLAC MEDSURGE (KETOROLAC TROMETAMOL) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Ketorolac trometamol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION KETOROLAC MEDSURGE solution for injection is available as a 30 mg/mL (3%) and 10 mg/mL (1%) sterile solution for injection for intramuscular (IM) administration only. Excipients with known effect: alcohol present as 12% v/v ethanol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM KETOROLAC MEDSURGE solution for injection: 10 mg/mL and 30 mg/mL clear and slightly yellow in colour, sterile solution in glass ampoules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KETOROLAC MEDSURGE 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 solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical a Lestu allt skjalið