Cisplatin Mylan Concentrate for Solution for Infusion 1mg/ml (100ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CISPLATIN

Available from:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC code:

L01XA01

INN (International Name):

CISPLATIN 1 mg

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CISPLATIN 1 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-07-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN MYLAN 1 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
Cisplatin
READ ALL OF THIS_ _LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you. Do not
_ _
pass it on to others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Cisplatin Mylan is and what it is used for
2.
Before you use Cisplatin Mylan
3.
How you use Cisplatin Mylan
4.
Possible side effects
5.
How to store Cisplatin Mylan
6.
Further information
CISPLATIN MYLAN CONCENTRATE FOR SOLUTION FOR INFUSION IS GIVEN ONLY BY
HEALTHCARE
PERSONNEL,WHO CAN REPLY TO ANY QUESTIONS, WHICH YOU MAY HAVE AFTER
READING THIS PACKAGE
LEAFLET.
1.
WHAT CISPLATIN MYLAN 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 (tumor of testis,
tumor of ovary, tumor of the bladder, head and neck epithelial tumor,
lung cancer and for cervical
cancer in combination with radiotherapy).
Your doctor will be able to provide you with more information.
_ _
2.
BEFORE YOU USE CISPLATIN MYLAN
DO NOT TAKE CISPLATIN MYLAN IF:
•
you are allergic (hypersensitive) to cisplatin or to any of the other
ingredients of Cisplatin
Mylan;
•
you are allergic (hypersensitive) to any other medicine that contains
platina compounds;
•
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 b

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cisplatin Mylan 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 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 :
Each ml of solution contains 9 mg (< 1mmol) 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 free from visible particles
The pH is between 3,5 and 6,5.
The osmoloarity is between 262 and 363 mOsmol/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisplatin Mylan 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 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
Cisplatin Mylan 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
(see section 6.2.).
ADULTS AND CHILDREN:
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The cisplatin dosage depends on the primary disease, the expected
reaction, and on whether
cisplatin is used for monotherapy or as a component of a combination
chemotherapy. The dos