Oxaliplatin Actavis

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OXALIPLATIN

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

L01XA03

INN (International Name):

OXALIPLATIN 5 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

OXALIPLATIN 5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-04-10

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

OXALIPLATIN ACTAVIS  
5 MG/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. 
- 
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 is and what it is used for 
2. Before 
you 
use 
Oxaliplatin. 
3. 
How to use Oxaliplatin. 
4. Possible 
side 
effects 
5. 
How to store Oxaliplatin 
6. Further 
information 

1. 
WHAT OXALIPLATIN IS AND WHAT IT IS USED FOR 

Oxaliplatin 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
anticancer agents, 5-fluorouracil (5-FU) and folinic acid (FS). 

2. 
BEFORE YOU USE OXALIPLATIN 

DO NOT USE OXALIPLATIN 
-  if you are allergic (hypersensitive) to oxaliplatin or the
other ingredient of Oxaliplatin, lactose 
monohydrate. 
-  if you are breast-feeding 
-  if you already have a reduced number of blood cells (white
blood cells and/or platelets). 
-  if you already have tingling and numbness
in the fingers and/or toes, and have difficulty 
performing delicate tasks, such as buttoning clothes 
-  if you have severe kidney problems 

EVEN IF YOU ARE MALE, PLEASE ENSURE THAT YOU READ THE
SECTION OF THIS LEAFLET THAT CONCERNS 
PREGNANCY AND BREAST-FEEDING. 

TAKE SPECIAL CARE WITH OXALIPLATIN 
-  if you have ever suffered an a

Summary of Product characteristics

Page 1 of 19 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Oxaliplatin Actavis 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 ml of the concentrate for solution for infusion contains
5mg oxaliplatin. 

10 ml vial: Each vial contains 50 mg oxaliplatin. 
20 ml vial: Each vial contains 100 mg oxaliplatin. 
40 ml vial: Each vial contains 200 mg oxaliplatin. 

Also contains lactose monohydrate 45 mg/ml. 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Concentrate for solution for infusion.  

Clear, colourless to pale yellow solution, free from visible
particles, and with a pH between 
4.0 – 7.0. 

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 (Dukes’ 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/m
2
 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.  

Page 2 of 19 
Oxaliplatin 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 was mainly used in combination with
continuous