Oxaliplatin 5mg/ml Concentrate for Solution for Infusion - (20ml vial)

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

OXALIPLATIN

Saadav alates:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC kood:

L01XA03

INN (Rahvusvaheline Nimetus):

OXALIPLATIN 5 mg/ml

Ravimvorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Koostis:

OXALIPLATIN 5 mg/ml

Retsepti tüüp:

POM

Terapeutiline ala:

ANTINEOPLASTIC AGENTS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2010-05-17

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5MG/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, 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 Concentrate for solution for infusion is and what
it is used for
2. What you need to know before you use Oxaliplatin Concentrate for
solution for infusion
3. How to use Oxaliplatin Concentrate for solution for infusion
4. Possible side effects
5. How to store Oxaliplatin Concentrate for solution for infusion
6. Contents of the pack and other information
1. WHAT OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION
IS AND WHAT IT IS USED FOR
The name of your medicine is Oxaliplatin 5 mg/ml Concentrate for
Solution for Infusion but in the
rest of the leaflet it will be called ‘Oxaliplatin concentrate for
solution for infusion’.
The active ingredient of Oxaliplatin concentrate for solution for
infusion is oxaliplatin.
Oxaliplatin concentrate for solution for infusion 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 concentrate for solution for infusion is used in
combination with other
anticancer medicines called 5 fluorouracil and folinic acid.
Oxaliplatin concentrate for solution for infusion has to be dissolved
and made into a solution before
it can be injected into a vein. Oxaliplatin concentrate for solution
for infusion is an antineoplastic or
anticancer drug and contains platinum.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN CONCENTRATE FOR
SOLUTION FOR INFUSION
YOU SHOULD NOT BE GIVEN OXALIPLATIN CONCENTRATE FOR SOLUTION FOR
INFUSION IF:
- You are allergic to

Toote omadused

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1.3.1
SPC, LABELLING AND PACKAGE LEAFLET
1.3.1
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 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 a pH in the
range of 3.5 and 6.5 and
125 m Osm/Ltr. to 175 m Osm/ Ltr. osmolarity.
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
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 until disease progression
or unacceptable
toxicity.
Dosage given should be adjusted according to tolerability (see section
4.4).
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OXALIPLATIN
SHOULD
ALWAYS
BE
ADMINISTERED
BEFORE
FLUOROPYRIMIDINES
–
I.E.
5
FLUOROURACIL.
Oxaliplatin concentrate for solution for infusion 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 concentrate for solution for infusion was mainly used in
combination with
continuou