FRAXIPARINE MULTIDOSE INJECTION 9500 iu AXAml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NADROPARIN CALCIUM

Available from:

DCH AURIGA SINGAPORE

ATC code:

B01AB06

Dosage:

9500 iu AXA/ml

Pharmaceutical form:

INJECTION

Composition:

NADROPARIN CALCIUM 9500 iu AXA/ml

Administration route:

INTRAVENOUS, SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

ASPEN NOTRE DAME DE BONDEVILLE

Authorization status:

ACTIVE

Authorization date:

2002-04-05

Patient Information leaflet

 
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

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