CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

País: Chipre

Língua: grego

Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes ativos:

CISPLATIN

Disponível em:

PFIZER HELLAS AE (0000003442) 243 MESSOGHION AVENUE, NEO PSYCHIKO, ATHENS, 15451

Código ATC:

L01XA01

DCI (Denominação Comum Internacional):

CISPLATIN

Dosagem:

1MG/ML

Forma farmacêutica:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composição:

CISPLATIN (0015663271) 1MG

Via de administração:

INTRAVENOUS USE

Tipo de prescrição:

Εθνική Διαδικασία

Área terapêutica:

CISPLATIN

Resumo do produto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 50ML (880049302) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML STERILE CONCENTRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTUSING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Cisplatin Sterile Concentrate is and what it is used for
2.
Before you use Cisplatin Sterile Concentrate
3.
How to use Cisplatin Sterile Concentrate
4.
Possible side effects
5.
How to store Cisplatin Sterile Concentrate
6.
Further information
1. WHAT CISPLATIN STERILE CONCENTRATEIS AND WHAT IT IS
USED FOR
Cisplatin Sterile Concentrate is an anti-cancer medicine. Treatment
with an anti-
cancer medicine is sometimes called cancer chemotherapy.
Cisplatin is used in the treatment of some types of cancer, for
example ovarian cancer,
testicular cancer, bladder cancer and cancer of the head and neck.
Cisplatin may be
used in combination with other anti-cancer medicines.
2. BEFORE YOU USE CISPLATIN STERILE CONCENTRATE
DO NOT USE CISPLATIN STERILE CONCENTRATE

if you have shown signs of hypersensitivity (severe allergy) to
cisplatin or
similar anti-cancer medicines in the past

if you have severe kidney disease

if you have hearing difficulties

if you have very low numbers of blood cells (called
‘myelosuppression’),
(your doctor will check this with a blood test)

if you are dehydrated

if you are breast-feeding

if you need to have a vaccine for ‘yellow fever’
Tell your doctorif the above applies to you before this medicine is
used.
TAKE SPECIAL CARE WITH CISPLATIN STERILE CONCENTRATE

if you have any symptoms of nerve damage (peripheral neuropathy)such
as
pins and needles, numbness or poor sense of touch

if you have had radiation therapy to your head
Tell your doctorifeither of the above applies to you before this
medicine is used.
TAKING/USING OTHER MEDICINE

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml Sterile Concentrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
cisplatin.
1 vial of 10 ml concentrate for solution for infusion contains 10 mg
of cisplatin. 1 vial
of 50 ml concentrate for solution for infusion contains 50 mg of
cisplatin. 1 vial of
100 ml concentrate for solution for infusion contains 100 mg of
cisplatin.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Infusion.
Vials containing a clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cisplatin is indicated in metastatic, non-seminomatous germ cell
carcinoma, advanced
stage and refractory ovarian carcinoma, advanced stages and refractory
bladder
carcinoma and squamous cell carcinoma of head and neck.
Cisplatin is indicated in combination with other antineoplastic agents
for the treatment
of metastatic testicular tumours. The combination of cisplatin,
vinblastine and
bleomycin is reported to be highly effective.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN
Cisplatin should be administered by IV infusion over a 6-8 hour
period. The
recommended dose of cisplatin in adults and children is 50 to 100 mg/m
2
as a single
IV dose every 3 to 4 weeks, or 15 to 20 mg/m
2
intravenously daily for 5 days every 3
to 4 weeks.
INTERACTION WITH ALUMINIUM:
Cisplatin may interact with metal aluminium to form a black
precipitate of platinum.
All aluminium-containing IV sets, needles, catheters and syringes
should be avoided.
(1)
Pretreatment Hydration:
Pretreatment hydration is required to induce diuresis during (and
after)
cisplatin administration. This hydration is achieved by giving 2
litres of either
0.9% sodium chloride or dextrose 4% in one-fifth normal saline (0.18%)
over
a 2-hour period.
During the last 30 minutes of the pre-treatment hydration or after the
hydration, administer by side arm drip 37.5 g of mannitol (i.e., 375