Cisplatin 50mg/50ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cisplatin

Available from:

Accord-UK Ltd

ATC code:

L01XA01

INN (International Name):

Cisplatin

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5060149313404

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1MG/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

Summary of Product characteristics

OBJECT 1
CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 09-Jan-2015 | Accord
Healthcare Limited
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.
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
100 ml 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