Cisplatin 1mg/ml Sterile Concentrate (100mL)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CISPLATIN

Available from:

Hospira UK Limited

ATC code:

L01AX01

INN (International Name):

CISPLATIN

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CISPLATIN 1 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-12-28

Patient Information leaflet

Page 1 of 8 2016-0018324
PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML STERILE CONCENTRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Cisplatin Sterile Concentrate is and what it is used for
2.
Before you use Cisplatin Sterile Concentrate
3.
How to use Cisplatin Sterile Concentrate
4.
Possible side effects
5.
How to store Cisplatin Sterile Concentrate
6.
Further information
1. WHAT CISPLATIN STERILE CONCENTRATE 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).
2. BEFORE YOU USE CISPLATIN STERILE CONCENTRATE
DO NOT USE CISPLATIN STERILE CONCENTRATE

if you have shown signs of hypersensitivity (severe allergy) to
cisplatin or
similar anti-cancer medicines in the past

if you have severe kidney disease

if you have hearing difficulties

if you have very low numbers of blood cells (called
‘myelosuppression’),
(your doctor will check this with a blood test)

if you are dehydrated

if you are breast-feeding

if you need to have a vaccine for ‘yellow fever’
Tell your doctor if the above applies to you before this medicine is
used.
TAKE SPECIAL CARE WITH CISPLATIN STERILE CONCENTRATE
Page 2 of 8 2016-0018324

if you have any symptoms of nerve damage (peripheral neuropathy) such
as
pins and needles, numbness or poor sense of touc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml Sterile Concentrate
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.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Infusion.
Vials containing a clear, colourless to pale yellow solution.
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 Sterile Concentrate is to be diluted before
administration. For
instructions for dilution of the product before administrate, 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.
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. The dosage directions are applicable for both adults and
children.
For monotherapy, the following two dosage regimens are recommended:
<< Single dose of 50 to 120 mg