Cisplatin 1mg/ml Concentrate for Solution for Infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Cisplatin

可用日期:

Accord Healthcare Limited

ATC代码:

L01XA; L01XA01

INN（国际名称）:

Cisplatin

剂量:

1 milligram(s)/millilitre

药物剂型:

Concentrate for solution for infusion

处方类型:

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

治疗领域:

Platinum compounds; cisplatin

授权状态:

Marketed

授权日期:

2011-10-07

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
Cisplatin
The name of your medicine is ‘Cisplatin 1 mg/ml Concentrate for
Solution
for Infusion’ but in the rest of the leaflet it will be called
“Cisplatin
Injection”.
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 further questions, ask your doctor,pharmacist or nurse.
•
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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Cisplatin Injection is and what it is used for
2. What you need to know before you use Cisplatin Injection
3. How to use Cisplatin Injection
4. Possible side effects
5. How to store Cisplatin Injection
6. Contents of the pack and other information 1. WHAT CISPLATIN INJECTION 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 cytostatics.
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 INJECTION
DO NOT TAKE CISPLATIN IF:
•
you are allergic to cisplatin or to any of the other ingredients of
this
medicine (listed in section 6
•
you are allergic (hypersensitive) to any other medicine that contains
platina compounds
•
you have kidney problems (renal dysfunction)
•
y

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisplatin 1mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
Cisplatin.
10 ml of concentrate for solution for infusion contains 10 mg of
Cisplatin
25 ml of concentrate for solution for infusion contains 25 mg of
Cisplatin
50 ml of concentrate for solution for infusion contains 50 mg of
Cisplatin
100ml of concentrate for solution for infusion contains 100 mg of
Cisplatin.
Excipients with known effect: Each ml of solution contains 3.5 mg of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to pale yellow solution in an amber glass vial,
which is practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisplatin is intended for the treatment of:
advanced or metastasised testicular cancer
advanced or metastasised ovarian cancer
advanced or metastasised bladder carcinoma
advanced or metastasised squamous cell carcinoma of the head and neck
advanced or metastasised non-small cell lung carcinoma
advanced 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 on
dilution of the product before administration (see section 6.6).
The diluted solution 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 (see section 6.2.).
ADULTS AND CHILDREN:
The cisplatin dosage depends on the primary disease, the expected
reaction, and on whether cisplati