Oxaliplatin 5mg/ml concentrate for Solution for Infusion - (10ml vial)

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

OXALIPLATIN

可用日期:

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

ATC代码:

L01XA03

INN（国际名称）:

OXALIPLATIN 5 mg/ml

药物剂型:

CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

OXALIPLATIN 5 mg/ml

处方类型:

POM

治疗领域:

ANTINEOPLASTIC AGENTS

授权状态:

Withdrawn

授权日期:

2010-05-17

资料单张

Page 1 of 13
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 , your 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 ‘{invented name}’ 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 oxaliplatin or any of the

产品特点

Page
1
of
24
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).
OXALIPLATIN
SHOULD
ALWAYS
BE
ADMINISTERED
BEFORE
FLUOROPYRIMIDINES
–
I.E.
5
FLUOROURACIL.
Page
2
of
24
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
continuous infusion 5-fluorouracil based regimens. For the two-weekly
treatment schedule
5-flu