Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
ketorolac trometamol, Quantity: 30 mg
Juno Pharmaceuticals Pty Ltd
Ketorolac trometamol
Injection, solution
Excipient Ingredients: sodium hydroxide; sodium chloride; water for injections; ethanol
Intramuscular
5 ampoules
(S4) Prescription Only Medicine
Ketorolac trometamol 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 "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. Note that oral dosage form can be available from other brand/s.,General,Ketorolac trometamol 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 trometamol solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).
Visual Identification: Clear and colourless or slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2014-08-20
KETOROLAC JUNO 1 KETOROLAC JUNO 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. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING KETOROLAC JUNO? Ketorolac Juno contains the active ingredient ketorolac trometamol. Ketorolac 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 JUNO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE KETOROLAC JUNO? Do not use if you are pregnant or intend to become pregnant, or if you are breastfeeding or intend to breastfeed. Do not use if you have ever had an allergic reaction to ketorolac 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. For more information, see Section 2. What should I know before I use KETOROLAC JUNO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ketorolac 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 JUNO? Ketorolac Juno 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 JUNO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING KETOROLAC JUNO? THINGS YOU SHOULD DO • Call your doctor straight away if you become pregnant while being treated with ketorolac. • Tell your doctor if you get an infection soon after receiving ketorolac. THINGS YOU SHOULD NOT DO • You should not receive ketorolac for longer than five days. Prolonged use may increase the occurrence of side effects. DRIVING OR USING MACHINES • B Прочитајте комплетан документ
Australian Product Information Ketorolac JUNO Product Information v6.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION KETOROLAC JUNO _(KETOROLAC TROMETAMOL) _ _ _ WARNING Ketorolac trometamol 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 trometamol 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. 1 NAME OF THE MEDICINE Ketorolac trometamol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KETOROLAC JUNO solution for injection contains the active ingredient, ketorolac trometamol. Ketorolac trometamol (synonym ketorolac tromethamine) is a non-narcotic analgesic belonging to the non-steroidal anti-inflammatory drug (NSAID) class of medicines with analgesic, anti-inflammatory and antipyretic properties. KETOROLAC JUNO solution for injection is available as a 30 mg/mL (3%) sterile solution for injection for intramuscular (IM) administration only. Excipients for the solution for injection are: ethanol, sodium chloride, water for injections and sodium hydroxide to adjust pH. 3. PHARMACEUTICAL FORM KETOROLAC JUNO solution for injection: 30 mg/mL clear and colourless or slightly yellow in colour, sterile solution in glass ampoules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KETOROLAC JUNO 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 _ Прочитајте комплетан документ