Cisplatin 1 mg/ml Concentrate for Solution for Infusion (50ml vial)

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

CISPLATIN

から入手可能:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATCコード:

L01XA01

INN（国際名）:

CISPLATIN 1 mg/ml

医薬品形態:

CONCENTRATE FOR SOLUTION FOR INFUSION

構図:

CISPLATIN 1 mg/ml

処方タイプ:

POM

治療領域:

ANTINEOPLASTIC AGENTS

認証ステータス:

Authorised

承認日:

2006-12-28

情報リーフレット

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
cisplatin
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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
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 1mg/ml Concentrate for Solution for Infusion is and
what it is used
for
2.
What you need to know before you use Cisplatin 1mg/ml Concentrate for
Solution for
Infusion
3.
How to use Cisplatin 1mg/ml Concentrate for Solution for Infusion
4.
Possible side effects
5.
How to store Cisplatin 1mg/ml Concentrate for Solution for Infusion
6.
Contents of the pack and other information
1. WHAT CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS USED
FOR
Cisplatin 1mg/ml Concentrate for Solution for Infusion contains the
active substance cisplatin
which 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISPLATIN 1MG/ML CONCENTRATE
FOR SOLUTION FOR
INFUSION
DO NOT USE CISPLATIN
•
if you are allerg

製品の特徴

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg 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.
Excipients with known effect:
Cisplatin 10 mg/10 ml (1 mg/ ml) concentrate for
solution for infusion contains 35.4 mg of
sodium in each 10 ml vial.
Cisplatin 50 mg/50 ml (1 mg/ ml) concentrate for solution for infusion
contains 177 mg of
sodium in each 50 ml vial.
Cisplatin 100 mg/100 ml (1 mg/ ml) concentrate for solution for
infusion contains 354 mg of
sodium in each 100 ml vial.
For the full list of excipients, see 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
Posology
ADULTS AND CHILDREN
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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. The
dosage directions are applicable for both adults and children.
Method of administration
For monotherapy, the following two dosag