Oxaliplatin Ebewe 5mg/ml powder for infusion

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

oxaliplatin 5 mg/ml

Beschikbaar vanaf:

Ebewe Pharma GmbH Nfg. KG

ATC-code:

L01XA03

INN (Algemene Internationale Benaming):

oxaliplatin

farmaceutische vorm:

powder for solution for infusion

Autorisatie-status:

Authorised

Autorisatie datum:

2008-01-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER 

OXALIPLATIN “EBEWE” 5 MG/ML POWDER FOR INFUSION 
Oxaliplatin 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE. 
-  Keep this leaflet. You may need to read it again. 
-  If you have further questions, please ask your doctor. 
-  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 „Ebewe“ is and what it is used for 
2. 
Before you are given Oxaliplatin „Ebewe“ 
3. 
How Oxaliplatin „Ebewe“ is given 
4. 
Possible side effects 
5 
How to store Oxaliplatin „Ebewe“ 
6. Further 
information 

1. 
WHAT OXALIPLATIN „EBEWE“ IS AND WHAT IT IS USED FOR 

Oxaliplatin „Ebewe“ is an anticancer drug and
contains platinum. 

Oxaliplatin „Ebewe“ 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 „Ebewe“ is used in
combination with other anticancer medicines
called 5-fluorouracil 
and folinic acid. 

2. 
BEFORE YOU ARE GIVEN OXALIPLATIN „EBEWE“ 

YOU SHOULD NOT BE GIVEN OXALIPLATIN „EBEWE“ IF YOU: 
• 
are ALLERGIC (HYPERSENSITIVE) to oxaliplatin
or any of the other ingredients of Oxaliplatin 
„Ebewe“ 
• 
are BREAST-FEEDING 
• 
already have a REDUCED NUMBER OF BLOOD CELLS 
• 
already have TINGLING AND NUMBNESS IN THE FINGERS AND/OR TOES,
and have DIFFICULTY 
PERFORMING DELICATE TASKS, such as buttoning clothes 
• 
have SEVERE KIDNEY PROBLEMS 

TAKE SPECIAL CARE (CHECK WITH YOUR DOCTOR) IF YOU: 
• 
have ever SUFFERED AN
ALLERGIC REACTION TO PLATINUM-CONTAINING MEDICINES such as 
CARBOPLATIN, CISPLATIN 
• 
have MODERATE KIDNEY PROBLEMS 
• 
have any liver problems 
• 
expe

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Oxaliplatin “Ebewe” 5 mg/ml powder for infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

One vial with lyophilised powder contains 50, 100 or 150mg of
oxaliplatin. 

One vial of 50mg: Each vial contains 50 mg oxaliplatin for
reconstitution in 10 ml of solvent. 

One vial of 100mg: Each vial contains 100 mg oxaliplatin for
reconstitution in 20 ml of solvent. 

One vial of 150mg: Each vial contains 150 mg oxaliplatin for
reconstitution in 30 ml of solvent. 

1ml of reconstituted solution for infusion contains 5mg of
oxaliplatin. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Powder for solution for infusion 
White to off-white compact powder. 

4. CLINICAL PARTICULARS 

4.1. THERAPEUTIC INDICATIONS 

Oxaliplatin “Ebewe” 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 medicines used, under conditions that
guarantee integrity of the 
medicinal product, protection of the environment and in particular
protection of the personnel 
handling
the medicines, according to 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 of oxaliplatin used in adjuvant treatment
is 85mg/m
2 
body surface area, 
Page 2 of 17 
administered intravenously every 2 weeks for 12 cycles
(6 months). 

The recommended dose of oxaliplatin for the