Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Tranexamic acid 100 mg/mL
Luminarie Group Limited
Tranexamic acid 100 mg/mL
100 mg/mL
Solution for injection
Active: Tranexamic acid 100 mg/mL Excipient: Water for injection
Prescription
Hunan Dongting Pharmaceutical Co Ltd
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.
Package - Contents - Shelf Life: Ampoule, glass, Type I clear, 5 x 5ml in printed carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.
2014-10-24
TRANEXAMIC ACID INJECTION 500MG/5ML AMPOULE NEW ZEALAND DATA SHEET LUMINARIE PTY LTD __________________________________________________________________________________ TRANEXAMIC ACID -LINK (Tranexamic acid) 1 NAME OF THE MEDICINE Tranexamic acid Tranexamic acid 500 mg/5mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TRANEXAMIC ACID LINK Solution for Injection contains 100 mg/mL tranexamic acid. Tranexamic acid is a white crystalline powder that is odourless or almost odourless. It is freely soluble in water and in glacial acetic acid, practically insoluble in methanol, ethanol, acetone, diethyl ether and benzene. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for Injection. Sterile, clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRANEXAMIC ACID LINK is indicated in the treatment of; 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 DOSE AND METHOD OF ADMINISTRATION INTRAVENOUS ADMINISTRATION _ADULT CARDIAC SURGERY_ After induction of anaesthesia and prior to skin incision, administer a pre-surgical loading dose of 15 mg/kg TRANEXAMIC ACID LINK, followed by infusion of 4.5 mg/kg/h for the TRANEXAMIC ACID INJECTION 500MG/5ML AMPOULE NEW ZEALAND DATA SHEET LUMINARIE PTY LTD __________________________________________________________________________________ duration of surgery. 0.6 mg/kg of this elder dose may be added in the priming volume of the heart- lung machine. _ADULT TOTAL KNEE ARTHROPLASTY_ Administration of 15 mg/kg TRANEXAMIC ACID LINK 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 i Prečítajte si celý dokument