OXALIPLATIN HOSPIRA 5 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXALIPLATIN

Available from:

Hospira UK Limited

ATC code:

L01XA03

INN (International Name):

OXALIPLATIN

Dosage:

5 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

Platinum compounds

Authorization status:

Authorised

Authorization date:

2008-02-08

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN HOSPIRA 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Oxaliplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Hospira is and what it is used for
2.
What you need to know before you use Oxaliplatin Hospira
3.
How to use Oxaliplatin Hospira
4.
Possible side effects
5
How to store Oxaliplatin Hospira
6.
Contents of the pack and other information
1.
WHAT OXALIPLATIN HOSPIRA IS AND WHAT IT IS USED FOR
The active ingredient of Oxaliplatin Hospira is oxaliplatin.
Oxaliplatin is an
anticancer drug that contains platinum.
Oxaliplatin 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 is used in combination with other anticancer
medicines called 5-
fluorouracil and folinic acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN HOSPIRA
DO NOT USE OXALIPLATIN HOSPIRA IF:

You are allergic to oxaliplatin or any of the other ingredients of
this medicine
(listed in section 6)

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, pharmacist or nurse before using Oxaliplatin
Hospira:

If you have ever suffered an allergic reaction to other
platinum-containing
medicines such as carboplatin or cisplatin. Allergic reactions can
occur during
oxaliplatin infusion.

If you have moderate or mild kidney problems.

If you have any

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxaliplatin Hospira 5 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 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 solution.
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 product 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 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 2 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).
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