Oxaliplatin 5mg/ml Concentrate for Solution for Infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Oxaliplatin

Disponibil de la:

Fresenius Kabi Oncology Plc

Codul ATC:

L01XA; L01XA03

INN (nume internaţional):

Oxaliplatin

Dozare:

5 milligram(s)/millilitre

Forma farmaceutică:

Concentrate for solution for infusion

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Platinum compounds; oxaliplatin

Statutul autorizaţiei:

Marketed

Data de autorizare:

2009-07-24

Prospect

00235 OXALIPLATIN RTU PACK INSERT-GBR+IRE-BORDON-PL 187270016 -
592X300
\\fre-kp-fp01\PDD-Artworks\Europe\Oxaliplatin\RTU\IRL+UK\PL
187270016\Bordon\2017 NOV\Masters\00235 Oxaliplatin RTU Pack
Insert-GBR+IRE-Bordon-PL 187270016 - 592x300.indd
Black
Font Size: 9 Pt.
Date: 28 Novemer 2018 Version: 05
Final Packaging Site: Bordon
Mfg. Site: Baddi-2
Font: Times New Roman
Dimension: 592x300 mm
Folding Size: 60x33 mm
_(Outline of folding size for indication purpose only, _
_it should be removed before final printing.)_
Form No.: SOP/PDD/014-02 Rev. 00
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Oxaliplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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 is and what it is used for
2. What you need to know before you use Oxaliplatin
3. How to use Oxaliplatin
4. Possible side effects
5. How to store Oxaliplatin
6. Contents of the pack and other information
1. WHAT OXALIPLATIN IS AND WHAT IT IS USED FOR
The active ingredient of oxaliplatin concentrate for solution for
infusion is oxaliplatin.
Oxaliplatin is an anti-cancer drug and is used to treat metastatic
(advanced) cancer of the colon (large bowel) or
rectum (back passage), or as additional treatment following surgery to
remove a tumour (growth) in the colon. It
is used in combination with other anti-cancer medicines called
5-fluorouracil (5-FU) and folinic acid (FA).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN
DO NOT USE OXALIPLATIN:
•
if you are allergic to Oxaliplatin or any of the other ingredients of
this medicine (listed in section 6).
•
if you are breastfeeding
•
if you already have a reduced numbe

Caracteristicilor produsului

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 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 solution, free from visible particles.
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
withknowledge 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 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 .
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in
250 to 500 ml of glucose 5% sol