FRAXIPARINE INJECTION 9500 IU AXA1.0 mL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NADROPARIN CALCIUM

Available from:

DCH AURIGA SINGAPORE

ATC code:

B01AB06

Pharmaceutical form:

INJECTION

Composition:

NADROPARIN CALCIUM 9500 IU AXA/1.0 mL

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

ASPEN NOTRE DAME DE BONDEVILLE

Authorization status:

ACTIVE

Authorization date:

2018-04-27

Summary of Product characteristics

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