Eloxatin 5 mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxaliplatin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

L01XA; L01XA03

INN (International Name):

Oxaliplatin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Platinum compounds; oxaliplatin

Authorization status:

Not marketed

Authorization date:

2006-05-05

Patient Information 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 to Oxaliplatin,
• 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 difficultly performing
delicate tasks, such as buttoning clothes,
• You have severe kidney problems.
WARNING 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,
• 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 called prolongation of the
QT interval, an irregular he

Summary of Product characteristics

Health Products Regulatory Authority
19 January 2023
CRN00DD5G
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eloxatin 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 a 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 (Duke's C) colon cancer after
complete resection of primary tumor.
• 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.
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.
Dosage 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 adm