Eloxatin 5mgml Concentrate for solution for infusion

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Oxaliplatin

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

L01XA03

Dosage:

5mg/ml

Pharmaceutical form:

INJECTION, SOLUTION, CONCENTRATE

Composition:

Oxaliplatin 5mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BEN VENUE LABORATORIES INC.

Authorization status:

ACTIVE

Authorization date:

2007-03-12

Patient Information leaflet

ELOXATIN 

[Sanofi aventis logo] 

1. NAME OF THE MEDICINAL PRODUCT 
Eloxatin 5 mg/ml concentrate for solution for infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml concentrate for solution for infusion contains 5
mg oxaliplatin. 
10 ml of concentrate for solution
for infusion contains 50 mg of oxaliplatin 
20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin 
40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin 
For full list of excipients see, see section 6.1 

3. PHARMACEUTICAL FORM 
Concentrate for solution for infusion. 
Clear, colourless liquid 

4. CLINICAL PARTICULARS 
_4.1 THERAPEUTIC INDICATIONS _
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic
acid (FA) is indicated for: 
• Adjuvant treatment of stage III (Duke's C) colon
cancer after complete resection of primary 
tumor 
• Treatment of metastatic colorectal cancer. 

_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _

Posology

FOR ADULTS ONLY 
The recommended dose for oxaliplatin in adjuvant setting is
85 mg/m
2
 intravenously, repeated every 
two weeks for 12 cycles (6 months). 
The recommended dose for oxaliplatin in treatment of
metastatic colorectal cancer is 85 mg/m
2

intravenously, repeated every 2 weeks. 

The dose should be adjusted according to tolerability (see section
4.4). 

OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES
- IE. 5-FLUOROURACIL. 
Oxaliplatin is administered as a 2-to
6-hour intravenous infusion in 250 to 500 ml of 5% glucose 
solution to give a concentration between 0.2 mg/ml and 0.70
mg/ml; 0.70 mg/ml is equivalent to 
the highest concentration in clinical practice for an oxaliplatin
dose of 85 mg/m
2
. 

Oxaliplatin was mostly administered in combination
with continuous infusion 5-fluorouracil . For 
the two

Summary of Product characteristics

ELOXATIN
Oxaliplatin
Concentrate for Solution for Infusion
NAME OF THE MEDICINAL PRODUCT
Eloxatin 5 mg/ml concentrate for solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 5 mg oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg of
oxaliplatin
20 ml of concentrate for solution for infusion contains 100 mg of
oxaliplatin
40 ml of concentrate for solution for infusion contains 200 mg of
oxaliplatin
For full list of excipients see, see section _List of excipients_
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONs
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid
(FA) is indicated for:
• Adjuvant treatment of stage III (Duke’s C) colon cancer after
complete resection of primary tumour
• Treatment of metastatic colorectal cancer.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m
2
intravenously, repeated every two weeks for
12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic
colorectal cancer is 85 mg/m
2
intravenously,
repeated every 2 weeks until disease progression or unacceptable
toxicity.
The dose should be adjusted according to tolerability (see section
_Special warnings and precautions for use_).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES –
I.E. 5-FLUOROURACIL (5-FU).
Oxaliplatin is administered as a 2-to 6-hour intravenous infusion in
250 to 500 ml of glucose 5% (50mg/ml) solution
to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml
is the highest concentration in clinical
practice for an oxaliplatin dose of 85 mg/m
2
.
Oxaliplatin has mainly been used in combination with continuous
infusion 5-fluorouracil (5-FU) based regimens. For
the two-weekly treatment schedule 5-fluorouracil (5-FU) regimens
combining bolus and continuous infusion were
used.
Special Populations