Oxaliplatin 5mg/ml Concentrate for Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Oxaliplatin

Предлага се от:

Accord Healthcare Limited

АТС код:

L01XA; L01XA03

INN (Международно Name):

Oxaliplatin

дозиране:

5 milligram(s)/millilitre

Лекарствена форма:

Concentrate for solution for infusion

Вид предписание :

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

Терапевтична област:

Platinum compounds; oxaliplatin

Статус Оторизация:

Marketed

Дата Оторизация:

2010-03-19

Листовка

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 doctor or your pharmacist.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharma-
cist.
IN THIS LEAFLET:
1. What Oxaliplatin Concentrate for solution for infusion is and what
it is used for
2. 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. Further 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. BEFORE YOU USE OXALIPLATIN CONCENTRATE FOR
SOLUTION FOR INFUSION
YOU SHOULD NOT BE GIVEN OXALIPLATIN CONCENTRATE FOR SOLUTION
FOR INFUSION
•
if you are allergic (hypersensitive) to oxaliplatin or any of the
other
ingredients of the Oxaliplatin concentrate for

Данни за продукта

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
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.
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 concentrate for solution for infusion 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 the highest
concentration in clinical practice for an oxaliplatin dose of 85 mg/m
2
.
Oxaliplatin concentrate for solution for infusion was mainly used in
combination with continuous infusion 5-
fluorouracil based regimens.
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