Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
tranexamic acid, Quantity: 100 mg/mL
AFT Pharmaceuticals Pty Ltd
Tranexamic acid
Injection
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Intravenous
10 ampoules, 5 ampoules, 1 ampoule
(S4) Prescription Only Medicine
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 liquid free of particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-11-09
1 AUSTRALIAN PRODUCT INFORMATION TRANEXAMIC-AFT (TRANEXAMIC ACID) 1 NAME OF THE MEDICINE Tranexamic acid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tranexamic-AFT contains tranexamic acid 500 mg per 5 mL or 1,000 mg per 10 mL ampoule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. Tranexamic-AFT is a sterile, clear, colourless solution containing tranexamic acid 500 mg per 5 mL or 1,000 mg per 10 mL ampoule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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, 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 heart-lung 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. 2 _ADULT TOTAL HIP ARTHROPLASTY _ Administration of 15mg/kg tranexamic acid immediately prior to skin incision, followed by a repeat bolus 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 (also see 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS ). _DOSAGE ADJUSTMENT IN THE ELDERLY _ No reduction in dosage is necessary, unless there is evidence of renal failure. _DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT _ Table 1: _ _ Adult Cardiac Surgery _ _ EGFR (ML/MIN Leggi il documento completo
Sequence n0001 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION TRANEXAMIC-AFT (TRANEXAMIC ACID) 1. NAME OF THE MEDICINE Tranexamic acid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tranexamic-AFT contains tranexamic acid 500 mg per 5 mL or 1,000 mg per 10 mL ampoule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. Tranexamic-AFT is a sterile, clear, colourless solution containing tranexamic acid 500 mg per 5 mL or 1,000 mg per 10 mL ampoule. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 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, 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 heart-lung 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 15mg/kg tranexamic acid immediately prior to skin incision, followed by a repeat bolus 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 (also see CLINICAL TRIALS). Sequence n0001 Page 2 of 23 _DOSAGE ADJUSTMENT IN THE ELDERLY _ No reduction in dosage is necessary, unless there is evidence of renal failure. _DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT _ _Table 1: Adult Cardiac Sur Leggi il documento completo