CISPLATIN 1 Mg/Ml Concentrate for Soln for Inf

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

CISPLATIN

から入手可能:

Hospira UK Limited

ATCコード:

L01XA01

INN（国際名）:

CISPLATIN

投薬量:

1 Mg/Ml

医薬品形態:

Concentrate for Soln for Inf

処方タイプ:

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

治療領域:

Platinum compounds

認証ステータス:

Authorised

承認日:

1986-11-19

情報リーフレット

S10462
PACKAGE LEAFLET:
INFORMATION FOR
THE USER
CISPLATIN 1 MG/ML
CONCENTRATE FOR SOLUTION
FOR INFUSION
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
or pharmacist.
•
If you get any side effects,
talk to your doctor or
pharmacist. This includes
any possible side effects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Cisplatin Concentrate for
Solution for Infusion is and what
it is used for
2. What you need to know before
you use Cisplatin Concentrate
for Solution for Infusion
3. How to use Cisplatin
Concentrate for Solution for
Infusion
4. Possible side effects
5. How to store Cisplatin
Concentrate for Solution for
Infusion
6. Contents of the pack and other
information
1. WHAT CISPLATIN
CONCENTRATE FOR SOLUTION
FOR INFUSION IS AND WHAT
IT IS USED FOR
Cisplatin forms part of a group of
medicines called cytostatics,
which are used in the treatment of
cancer. Cisplatin can be used
alone but more commonly cisplatin
is used in combination with other
cyostatics.
WHAT IS IT USED FOR?
Cisplatin can destroy cells in your
body that may cause certain types
of cancer (tumour of testis, tumour
of ovary, tumour of the bladder,
head and neck epithelial tumour,
lung cancer and for cervical
cancer in combination with
radiotherapy).
Your doctor will be able to provide
you with more information.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE CISPLATIN
CONCENTRATE FOR SOLUTION
FOR INFUSION
DO NOT USE CISPLATIN
CONCENTRATE FOR SOLUTION FOR
INFUSION
•
if you are allergic to cisplatin or
similar anti-cancer medicines in
the past or any of the other
ingredients of this medicine
(see section 6)
•
if you have very low numbers of
blood cells (called
‘myelosuppression’), (your
doctor will check this with a
blood test)
•
if you are pregnant or breast
feeding
•
if you have severe kidney
disease
•
if you have hearing diff

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of concentrate for solution for infusion contains 1mg of
cisplatin.
1 vial of 10 ml concentrate for solution for infusion contains 10 mg
of cisplatin. 1 vial of 50 ml concentrate for solution
for infusion contains 50 mg of cisplatin. 1 vial of 100 ml concentrate
for solution for infusion contains 100 mg of
cisplatin.
Also contains sodium 9mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Solution for Infusion.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisplatin is intended for the treatment of:
Advance or metastasised testicular cancer
Advance or metastasised ovarian cancer
Advance or metastasised bladder carcinoma
Advance or metastasised squamous cell carcinoma of the head and neck
Advance or metastasised non-small cell lung carcinoma
Advance or metastasised small cell lung carcinoma
Cisplatin is indicated in the treatment of cervical carcinoma in
combination with other chemotherapeutics or with
radiotherapy.
Cisplatin can be used as monotherapy and in combination therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cisplatin 1 mg/ml Concentrate for solution for infusion is to be
diluted before administration. For instructions for
dilution of the product before administrate, see section 6.6.
The dilution should be administered only intravenously by infusion
(see below). For administration, any device
containing aluminium that may come in contact with cisplatin (sets for
intravenous infusion, needles, catheters,
syringes) must be avoided.
ADULTS AND CHILDREN
The cisplatin dosage depends on the primary disease, the expected
reaction and on whether cisplatin is used for
monotherapy or as a component of combination chemotherapy.
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