Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
NADROPARIN CALCIUM
DCH AURIGA SINGAPORE
B01AB06
950 iu AXA/0.1 ml
INJECTION
NADROPARIN CALCIUM 2850 IU AXA/0.3 mL
SUBCUTANEOUS
Prescription Only
ASPEN NOTRE DAME DE BONDEVILLE
ACTIVE
1988-06-25
CONFIDENTIAL 1 FRAXIPARINE™/FRAXIPARINE FORTE™ NADROPARIN QUALITATIVE AND QUANTITATIVE COMPOSITION _FRAXIPARINE™ INJECTION 950 IU AXA/0.1ML_ [NADROPARIN CALCIUM SOLUTION FOR INJECTION 950 IU AXA/0.1ML] _PRE-FILLED SYRINGES: _ - 0.2 ml of solution equivalent to 1,900 anti-Xa IU - 0.3 ml of solution equivalent to 2,850 anti-Xa IU - 0.4 ml of solution equivalent to 3,800 anti-Xa IU _GRADUATED PRE-FILLED SYRINGES: _ - 0.6 ml of solution equivalent to 5,700 anti-Xa IU - 0.8 ml of solution equivalent to 7,600 anti-Xa IU - 1 ml of solution equivalent to 9,500 anti-Xa IU _FRAXIPARINE™ MULTIDOSE INJECTION 9500 IU AXA/ML _[NADROPARIN CALCIUM SOLUTION FOR INJECTION 9500 IU AXA/ML] _MULTI DOSE VIALS: _ - 5 ml of solution equivalent to 47,500 anti-Xa IU - 15 ml of solution equivalent to 142,500 anti-Xa IU _FRAXIPARINE_ _FORTE™_ _INJECTION 19,000 IU AXA/ML_ [NADROPARIN CALCIUM DOUBLE STRENGTH SOLUTION FOR INJECTION 19,000 IU AXA/ML] _GRADUATED PRE-FILLED SYRINGES: _ - 0.6 ml of solution equivalent to 11,400 anti-Xa IU - 0.8 ml of solution equivalent to 15,200 anti-Xa IU - 1 ml of solution equivalent to 19,000 anti-Xa IU PHARMACEUTICAL FORM Solution for injection. CONFIDENTIAL 2 CLINICAL PARTICULARS INDICATIONS _FRAXIPARINE™ INJECTION 950 IU AXA/0.1ML_ [NADROPARIN CALCIUM SOLUTION FOR INJECTION 950 IU AXA/0.1ML] _FRAXIPARINE™ MULTIDOSE INJECTION 9500 IU AXA/ML _[NADROPARIN CALCIUM SOLUTION FOR INJECTION 9500 IU AXA/ML] The prophylaxis of thromboembolic disorders, such as: - those associated with general or orthopaedic surgery - those in high risk medical patients (respiratory failure and/or respiratory infection and/or cardiac failure), hospitalised in intensive care unit The treatment of thromboembolic disorders. The prevention of cl Lugege kogu dokumenti
964INS000003SG In patients with moderate renal impairment (creatinine clearance 36-43 ml/min), both mean AUC and half-life were increased by 52 and 39% respectively compared with healthy volunteers. In these patients, mean plasma clearance of nadroparin was decreased to 63% of normal. Wide inter-individual variability was observed in the study. In subjects with severe renal impairment (creatinine clearance 10-20 ml/min) both mean AUC and half-life were increased by 95 and 112% respectively compared with healthy volunteers. Plasma clearance in patients with severe renal impairment was decreased to 50% of that observed in patients with normal renal function. In subjects with severe renal impairment (creatinine clearance 3-6 ml/min) on haemodialysis, both mean AUC and half-life were increased by 62 and 65% respectively compared with healthy volunteers. Plasma clearance in haemodialysis patients with severe renal impairment was decreased to 67% of that observed in patients with normal renal function (see Dosage and Administration, Warnings and Precautions). Aspen Notre Dame de Bondeville 1 Oct 2021 ITEM NUMBER : 360x332mm MATERIAL : DIMENSION : Folded (180x63mm) FINISHING : 2 VERSION : Sin Yi 30/SEP/2021 NAME : DATE : DATE : 25/NOV/2021 APPROVE : DATE : COLOR CODE : CREATIVE SPREADPRINT PTE LTD ZUELLIG 964INS000003SG BLACK 50gsm Woodfree Dose reduction is not required in patients with mild renal impairment (creatinine clearance greater than or equal to 50 ml/min). Moderate and severe renal impairment is associated with increased exposure to nadroparin. These patients are at increased risk of thromboembolism and haemor- rhage. If a dose reduction is considered appropriate by the prescribing physician, taking into account the individual risk factors for haemorrhage and thromboembolism in patients with moderate renal impairment (creatinine clearance greater than or equal to 30 ml/min and less than 50 ml/min) the dose should be reduced by 25 to 33% (see Warnings and Precautions and Pharmacokinet- ics). The dose should be Lugege kogu dokumenti