Oxaliplatin Ebewe - (100mg vial) Pdr for Soln for Infusion 5mg/ml

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

OXALIPLATIN

Beszerezhető a:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC-kód:

L01XA03

INN (nemzetközi neve):

OXALIPLATIN 5 mg/ml

Gyógyszerészeti forma:

POWDER FOR SOLUTION FOR INFUSION

Összetétel:

OXALIPLATIN 5 mg/ml

Recept típusa:

POM

Terápiás terület:

ANTINEOPLASTIC AGENTS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2008-01-29

Betegtájékoztató

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN EBEWE 5 MG/ML POWDER FOR SOLUTION FOR INFUSION
oxaliplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oxaliplatin Ebewe is and what it is used for
2.
What you need to know before you are given Oxaliplatin Ebewe
3.
How Oxaliplatin Ebewe is given
4.
Possible side effects
5
How to store Oxaliplatin Ebewe
6.
Contents of the pack and other information
1.
WHAT OXALIPLATIN EBEWE IS AND WHAT IT IS USED FOR
Oxaliplatin Ebewe is an anticancer medicine and contains the active
substance oxaliplatin
Oxaliplatin Ebewe is used for treating bowel cancer after it has been
removed by surgery or when it
has already spread. Oxaliplatin Ebewe is used in combination with
other anticancer medicines
called 5-fluorouracil (5-FU) and folinic acid (FA).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OXALIPLATIN EBEWE
YOU SHOULD NOT BE GIVEN OXALIPLATIN EBEWE:
•
if you are
ALLERGIC
to oxaliplatin if you are
BREAST-FEEDING
•
if you already have a
REDUCED NUMBER OF BLOOD CELLS
•
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
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Oxaliplatin Ebewe
•
If you have ever
SUFFERED AN ALLERGIC REACTION TO PLATINUM-CONTAINING MEDICINES
such as
CARBOPLATIN, CISPLATIN. ALLERGIC REACTIONS CAN OCCURE DURING ANY
OXALIPLATIN INFUSION.
•
If you have mild or
MODERATE KIDNEY PROBLEMS
•
If you have any liver problems or abnormal liver function test results
during your treatment.
•
If you have or had heart disorders such as an

Termékjellemzők

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxaliplatin Ebewe 5mg/ml powder for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with lyophilised powder contains 50mg, 100mg 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 the 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 (Dukes 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 medicinal products, according to 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 for detailed
information).
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Posology
FOR ADULTS ONLY
The recommended dose of oxaliplatin used in adjuvant treatment is
85mg/m
2
body surface area,
administered intravenously every 2 weeks for 12 cycles (6 months).
The recommended dose of oxaliplatin for the treatment of metastatic
colorectal cancer is 85 mg/m
2
body
surface
area,
administered
intravenously
every
2
weeks
until
disease
progression
or
unacceptable toxicity.
Dosage given sh