Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
tranexamic acid, Quantity: 500 mg
Medsurge Pharma Pty Ltd
Tranexamic acid
Injection, intravenous infusion
Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid
Intravenous
5 packs of 5mL ampoules
(S4) Prescription Only Medicine
Intravenous Administration,Adults - For the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty.,Paediatrics - For the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.
Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-04-23
ZAMIC CMI V3.0 (MARCH 2018) 1 ZAMIC _TRANEXAMIC ACID _ CONSUMER MEDICINE INFORMATION What is in this leaflet Please read this leaflet carefully before you start taking Zamic. This leaflet answers some common questions about Zamic. 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 taking Zamic against the expected benefits it will have for you. Use Zamic as instructed and follow the advice given in this leaflet. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. What Zamic injection is used for Zamic is used to reduce bleeding and the need for transfusion of blood in patients undergoing heart surgery, total knee replacement and total hip replacement surgery. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. How Zamic works Zamic contains tranexamic acid. Tranexamic acid is an antifibrinolytic that works by slowing the processes that cause bleeding. Before taking Zamic _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ZAMIC IF YOU HAVE AN ALLERGY TO ZAMIC OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE ZAMIC IF YOU ARE BEING TREATED FOR A STROKE. DO NOT TAKE ZAMIC IF YOU ARE BEING TREATED FOR BLOOD CLOTS IN YOUR LEGS, LUNGS OR ANYWHERE ELSE IN YOUR BODY. DO NOT TAKE ZAMIC IF YOU HAVE A PROBLEM WITH COLOUR VISION THAT DEVELOPED AFTER YOU WERE BORN. DO NOT TAKE ZAMIC AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you take this medicine after the expiry date has passed, it may not work as well. DO NOT TAKE ZAMIC IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. _BEFORE YOU START TO TAKE IT _ _ _ YOU MUST TELL YOUR DOCTOR ABOUT ALL OF THE FOLLOWING BEFORE YOU START TO TAKE ZAMIC: • if you or someone in your family has ever suffered from blood clots • if you have severe bruising • if yo Læs hele dokumentet
ZAMIC _ _ PRODUCT INFORMATION Edition 5.0 Jun 2022 PAGE 1 of 25 AUSTRALIAN PRODUCT INFORMATION ZAMIC (TRANEXAMIC ACID 500 MG/5 ML) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Tranexamic acid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tranexamic acid 500 mg/5 mL Each 5 mL ampoule of Tranexamic Acid solution for injection contains 500 mg tranexamic acid, hydrochloric acid QS for pH adjustment, sodium hydroxide QS for pH adjustment and water for injections QS to 5 mL as the inactive ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. Tranexamic acid solution for injection is a sterile, clear, colourless solution free from visible particles, presented in glass ampoules. The pH is 6.5 to 7.5. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS INTRAVENOUS ADMINISTRATION ADULTS For the reduction of peri– and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. PAEDIATRICS For the reduction of peri– and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery. 4.2 D OSE AND METHOD OF ADMINISTRATION TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL ADMINISTRATION. ZAMIC _ _ PRODUCT INFORMATION Edition 5.0 Jun 2022 PAGE 2 of 25 ADULT CARDIAC SURGERY After induction of anaesthesia and prior to skin incision, administer a pre-surgical loading dose of 15 mg/kg tranexamic acid, followed by infusion of 4.5 mg/kg/h for the duration of surgery. 0.6 mg/kg of this infusion dose may be added in the priming volume of the heartlung machine. ADULT TOTAL KNEE ARTHROPLASTY Administration of 15 mg/kg tranexamic acid prior to release of the tourniquet followed by repeat bolus injection of 15 mg/kg at 8 hourly intervals after the initial dose. The last bolus dose is to be administered 16 hours after the initial dose. ADULT TOTAL HIP ARTHROPLASTY Administration of 15 mg/kg tranexamic acid immediately prior to Læs hele dokumentet