Cisplatin 1 mg/ml (100ml vial) concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CISPLATIN

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

L01XA01

INN (International Name):

CISPLATIN 1 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CISPLATIN 1 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-04-29

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
cisplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
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”.
WHAT IS IN THIS LEAFLET
1.
What Cisplatin Injection is and what it is used for
2.
What you need to know before you are given Cisplatin Injection
3.
How you are given 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.
Cisplatin is used to treat cancers of the testis, ovary, urinary
bladder, head and neck, and
lung.
Cisplatin is used to treat 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 ARE GIVEN CISPLATIN INJECTION
_ _
DO NOT TAKE CISPLATIN INJECTION:

If you are allergic (hypersensitive) to cisplatin or other platinum
compounds or to any
of the other ingredients of this medicine (listed in section 6),

If you have kidney problems (renal dysfunction)

If you suffer from dehydration

you suffer from severe suppression of bone m

Summary of Product characteristics

Page 1 of 16
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.
One vial of 10 ml of concentrate for solution for infusion contains 10
mg of cisplatin
One vial of 50 ml of concentrate for solution for infusion contains 50
mg of cisplatin
One vial of 100 ml of concentrate for solution for infusion contains
100 mg of cisplatin
Excipient with known effect:
Each ml of solution contains 3.5 mg of sodium.
For a 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.
The pH is between 3.5 to 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisplatin is intended for the treatment of:

advanced or metastatic testicular cancer

advanced or metastatic ovarian cancer

advanced or metastatic bladder carcinoma

advanced or metastatic squamous cell carcinoma of the head and neck

advanced or metastatic non-small cell lung carcinoma

advanced or metastatic small cell lung carcinoma
Cisplatin is indicated in combination with radiotherapy in the
treatment of cervical carcinoma.
Cisplatin can be used as monotherapy and in combination therapy
Page 2 of 16
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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/m² body surface every 3 to 4 weeks;

15 to 20 mg/m²/day for five days, every 3 to 4 weeks.
If cisplatin is used in combination chemotherapy, the dose of
cisplatin must be reduced. A
typical dose is 20 mg/m²