Oxaliplatin 5mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxaliplatin

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01XA; L01XA03

INN (International Name):

Oxaliplatin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Platinum compounds; oxaliplatin

Authorization status:

Marketed

Authorization date:

2010-03-19

Patient Information leaflet

IE/H/0756/001/IB/044, ver 03, Feb 2024 PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5MG/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, pharmacist or
nurse.
•
If you get any side effects talk to your 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 Oxaliplatin Concentrate for solution for infusion is and what
it is used for
2. What you need to know before you use Oxaliplatin Concentrate for
solution for infusion
3. How to use Oxaliplatin Concentrate for solution for infusion
4. Possible side effects
5. How to store Oxaliplatin Concentrate for solution for infusion
6. Contents of the pack and other information
1. WHAT OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION
IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Oxaliplatin 5mg/ml Concentrate for
Solution for Infusion’ but in the rest of the leaflet it
will be called ‘Oxaliplatin concentrate for solution for
infusion’.
The active ingredient of Oxaliplatin concentrate for solution for
infusion is oxaliplatin.
Oxaliplatin concentrate for solution for infusion 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). Oxaliplatin concentrate for
solution for infusion is used in combination with other anticancer
medicines called 5 fluorouracil and folinic acid.
Oxaliplatin concentrate for solution for infusion has to be dissolved
and made into a solution before it can be injected into
a vein. Oxaliplatin concentrate for solution for infusion is an
antineoplastic or anticancer drug and contains platinum.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN CONCENTRATE FOR
SOLUTION FOR INFUSION
DO NOT USE OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION IF:
•

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2024
CRN00DXK6
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxaliplatin 5mg/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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution, free from visible particles a pH in the
range of 3.5 and 6.5 and 125 m Osm/Ltr. to 175 m Osm/ Ltr.
osmolarity.
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 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 (see section
6.6).
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 the onset of unacceptable toxicity.
Dosage given should be adjusted according to tole