Cisplatin 1 mg/ml concentrate for solution for infusion

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Cisplatin

Beszerezhető a:

Fresenius Kabi Oncology Plc

ATC-kód:

L01XA; L01XA01

INN (nemzetközi neve):

Cisplatin

Adagolás:

1 milligram(s)/millilitre

Gyógyszerészeti forma:

Concentrate for solution for infusion

Recept típusa:

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

Terápiás terület:

Platinum compounds; cisplatin

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2014-05-02

Betegtájékoztató

Ver 005, July 2014
PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Cisplatin
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 is and what it is used for
2.
What you need to know before you use Cisplatin
3.
How to use Cisplatin
4.
Possible side effects
5.
How to store Cisplatin
6.
Contents of the pack and other information
1.
WHAT CISPLATIN 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 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 USE CISPLATIN
DO NOT TAKE CISPLATIN IF:
•
if you are allergic (hypersensitive) to cisplatin or other platinum
compounds or any of the other
ingredients of this medicine (listed in section 6)
•
you have kidney problems (renal dysfunction)
•
you suffer from dehydration
•
you suffer from severe suppression of bone marrow functionality,
symptoms may be: extreme
tiredness, easy bruising or bleeding, occurrence of infections
•
your hearing is impaired
•
you suffer from nervous disorders caused by cisplatin
•
you are breast-feeding
•
combined with yellow vaccine and phenytoin (see

Termékjellemzők

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 concentrate for solution for infusion contains 10 mg
of cisplatin.
One vial of 20 ml concentrate for solution for infusion contains 20 mg
of cisplatin.
One vial of 50 ml concentrate for solution for infusion contains 50 mg
of cisplatin.
One vial of 100 ml concentrate for solution for infusion contains 100
mg of cisplatin.
Excipient(s) with known effect:
Each ml of solution contains 0.1 to 0.2 millimoles per ml 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.
The pH is between 3.5 to 6.5.
The osmolarity is between 250 to 400 mOsmol/L.
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.
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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___