Oxaliplatin 5mg/ml Powder for Solution for Infusion

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

OXALIPLATIN

זמין מ:

Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

קוד ATC:

L01XA03

INN (שם בינלאומי):

OXALIPLATIN 5 mg/ml

טופס פרצבטיות:

POWDER FOR SOLUTION FOR INFUSION

הרכב:

OXALIPLATIN 5 mg/ml

סוג מרשם:

POM

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

מצב אישור:

Withdrawn

תאריך אישור:

2010-12-21

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER 
OXALIPLATIN 5 MG/ML POWDER 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 further questions, please ask your doctor. 
•  This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if 
their symptoms are the same as yours. 
•  If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please 
tell your doctor.  
IN THIS LEAFLET: 
1. What Oxaliplatin Powder for Solution for Infusion is and what it is
used for 
2. Before you are given Oxaliplatin Powder for Solution for Infusion

3. How Oxaliplatin Powder for Solution for Infusion is given 
4. Possible side effects 
5. How to store Oxaliplatin Powder for Solution for Infusion 
6. Further information 

1. WHAT OXALIPLATIN POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT
IS USED FOR 

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. BEFORE YOU ARE GIVEN OXALIPLATIN POWDER FOR SOLUTION
FOR INFUSION 

DO NOT USE OXALIPLATIN POWDER FOR SOLUTION FOR INFUSION  
If you are allergic (hypersensitive) to Oxaliplatin or any of the
other ingredients of the Oxaliplatin Powder 
for Solution for Infusion. 
If you have impaired bone marrow function. 
If you have severe kidney disease. 
If you are breast feeding. 
If you already have tingling and numbness in the fingers and/or toes,
and have difficulty performing delicate 
tasks, such as buttoning clothes. 
Even if you are male, please ensure that you read the section of this
leaflet that concerns pregnancy

מאפייני מוצר

1 of 21 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Oxaliplatin 5 mg /ml Powder for Solution for Infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

One ml of reconstituted solution contains oxaliplatin 5 mg.  
Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Powder for solution for infusion. 

A white to off-white powder  

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.  

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.  

Dosa