Oxaliplatin 5 mg/ml concentrate for solution for infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Oxaliplatin

から入手可能:

Fresenius Kabi Deutschland GmbH

ATCコード:

L01XA; L01XA03

INN（国際名）:

Oxaliplatin

投薬量:

5 milligram(s)/millilitre

医薬品形態:

Concentrate for solution for infusion

治療領域:

Platinum compounds; oxaliplatin

認証ステータス:

Marketed

承認日:

2009-07-24

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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 is and what it is used for
2.
What you need to know before you use Oxaliplatin
3.
How to use Oxaliplatin
4.
Possible side effects
5.
How to store Oxaliplatin
6.
Contents of the pack and other information
1.
WHAT OXALIPLATIN IS AND WHAT IT IS USED FOR
The active ingredient of oxaliplatin concentrate for solution for
infusion is oxaliplatin.
Oxaliplatin 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 is used in
combination with other anticancer medicines called 5-fluorouracil and
folinic acid.
Oxaliplatin is an antineoplastic or anticancer drug and contains
platinum.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN
DO NOT USE OXALIPLATIN IF
:
•
You are allergic to oxaliplatin or any of the other ingredients of
this medicine (listed in section 6).
•
You are breast-feeding.
•
You already have a reduced number of blood cells.
•
You already have tingling and numbness in the fingers and/or toes, and
have difficulty performing
delicate tasks, such as buttoning clothes.
•
You have severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before using Oxaliplatin
•
if you have ever suffered an allergic reaction to platinum-containing
medicines such as carboplatin,
cisplatin. Allergic reactions can occur during any oxaliplatin
infusion
•
if you have mild or moderate kidney problems
•
if you hav

製品の特徴

Health Products Regulatory Authority
11 October 2022
CRN00CXXM
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxaliplatin 5 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of 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.
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/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.
Dose given should be adjusted according to tolerability (see section
4.4).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES-
I.E. 5-FLUOROURACIL.
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 infusion
5-fluorouracil based regimens. For the two-weekly
treatment schedule 5-fluorouracil regimens combining bolus and
continuous infusion were used.
Special