Cisplatin 1mg/ml Concentrate for Solution for Infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Cisplatin

Saadav alates:

Accord Healthcare Ireland Ltd.

ATC kood:

L01XA; L01XA01

INN (Rahvusvaheline Nimetus):

Cisplatin

Annus:

1 milligram(s)/millilitre

Ravimvorm:

Concentrate for solution for infusion

Terapeutiline ala:

Platinum compounds; cisplatin

Volitamisolek:

Marketed

Loa andmise kuupäev:

2011-10-07

Infovoldik

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 any further questions, ask your doctor, pharmacist or
nurse.
-
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 Injection 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
cytostatics.
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 INJECTION
_ _
DO NOT USE CISPLATIN INJECTION:
•
if you are allergic to cisplatin, similar anti-cancer medicines, other
platinum containing
compounds or to any of the other ingredients of this medicine (listed
in section 6)
•
if you have very low numbers of blood cells (called
‘myelosuppression’), (your doctor will
check this w

Toote omadused

Health Products Regulatory Authority
20 September 2023
CRN00DV1X
Page 1 of 11
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
Posology
_Adults and paediatric population_
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 cis