Eloxatin Concentrate for Soln for Inf 5mg/ml (20ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OXALIPLATIN

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

L01XA03

INN (International Name):

OXALIPLATIN 5 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

OXALIPLATIN 5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2006-09-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOXATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, your pharmacist or
nurse.
•
If you get any side effects, talk to you doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ELOXATIN is and what it is used for
2.
What you need to know before you use ELOXATIN
3.
How to use ELOXATIN
4.
Possible side effects
5.
How to store ELOXATIN
6.
Contents of the pack and other information
1.
WHAT ELOXATIN IS AND WHAT IT IS USED FOR
The active ingredient of ELOXATIN is oxaliplatin..
ELOXATIN is used to treat cancer of the large bowel (treatment of
stage III colon cancer after
complete resection of primary tumour, metastatic cancer of colon and
rectum). ELOXATIN is used
in combination with other anticancer medicines called 5 fluorouracil
and folinic acid.
ELOXATIN is an antineoplastic or anticancer drug and contains
platinum.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELOXATIN
DO NOT USE ELOXATIN IF:
•
You are allergic tothis medicine.
•
You are breast-feeding.
•
You already have a reduced number of blood cells.
•
You already have tingling and numbness in the fingers and/or toes, and
have difficulty
performing delicate tasks, such as buttoning clothes.
•
You have severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking ELOXATIN
•
If you have ever suffered an allergic reaction to platinum-containing
medicines such as
carboplatin, cisplatin. Allergic reactions can occur during any
oxaliplatin infusion.
•
If you have moderate or mild kidney problems,
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•
If you have any liver problems or abnormal liver function test results
during your treatment,
•
If you have or had heart disorders such as an abnormal electrical
signal calle

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Eloxatin 5 mg/ml concentrate for solution for infusion / Foxantal 5
mg/ml concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of 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 the full list of excipients, 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 (Dukes C) colon cancer after complete
resection of primary
tumour
•
Treatment of metastatic colorectal cancer
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The preparation of injectable solutions of cytotoxic agents must be
carried out by trained specialist
personnel with knowledge of the medicinal products used, in conditions
that guarantee the
integrity of the medicinal
_ _
product, the protection of the environment and in particular the
protection of the personnel handling the medicinal products, in
accordance with the hospital
policy. It requires a preparation area reserved for this purpose. It
is forbidden to smoke, eat or
drink in this area.
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Posology
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m²
intravenously repeated every
two weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic
colorectal cancer is 85 mg/m²
intravenously repeated every 2 weeks until disease progression or
unacceptable toxicity.
Dose given should be adjusted according to tolerability (see section
4.4).
OXALIPLATIN
SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES, I.E. 5
FLUOROURACIL
(5 FU).
Oxaliplatin is administered as a 2- to