OXALIPLATIN 5 Mg/Ml Concentrate for Soln for Inf

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

OXALIPLATIN

Pieejams no:

Generics (UK) Limited

ATĶ kods:

L01XA03

SNN (starptautisko nepatentēto nosaukumu):

OXALIPLATIN

Deva:

5 Mg/Ml

Zāļu forma:

Concentrate for Soln for Inf

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Platinum compounds

Autorizācija statuss:

Authorised

Autorizācija datums:

2014-12-05

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
oxaliplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING 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, 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 5 mg/ml concentrate for solution for infusion is and
what it is used
for
2.
What you need to know before being given Oxaliplatin 5 mg/ml
concentrate for
solution for infusion
3.
How Oxaliplatin 5 mg/ml concentrate for solution for infusion is given
4.
Possible side effects
5.
How to store Oxaliplatin 5 mg/ml concentrate for solution for infusion
6.
Contents of the pack and other information
1.
WHAT OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS
USED FOR
This medicine contains the active substance oxaliplatin. Oxaliplatin 5
mg/ml concentrate
for solution for infusion is an antineoplastic or anticancer drug and
contains platinum.
Oxaliplatin 5 mg/ml 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 is used in
combination with other
anticancer medicines called 5-fluorouracil and folinic acid.
2.
WHAT YOU NEED TO KNOW BEFORE BEING GIVEN OXALIPLATIN 5 MG/ML
CONCENTRATE FOR
SOLUTION FOR INFUSION
YOU MUST NOT BE GIVEN OXALIPLATIN 5 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION IF
YOU:
-
are allergic to oxaliplatin
-
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.
You must not breast-feed whilst you are treated with oxalipl

Produkta apraksts

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 concentrate for solution for infusion contains 5 mg of
oxaliplatin.
10 ml concentrate for solution for infusion contains 50 mg of
oxaliplatin.
20 ml concentrate for solution for infusion contains 100 mg of
oxaliplatin.
40 ml concentrate for solution for infusion contains 200 mg of
oxaliplatin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The solution has a pH between 4.5 and 6.0 and an osmolarity of not
more than 305 mOsmol/l.
Clear, colourless liquid, 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 (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.
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in
250 to 500 ml of glucose 5 % (50 mg/ml) solution
to give a concentration between 0.20 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 inf