Cisplatin 1 mg/ml concentrate for solution for infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Cisplatin

可用日期:

Fresenius Kabi Deutschland GmbH

ATC代码:

L01XA; L01XA01

INN（国际名称）:

Cisplatin

剂量:

1 milligram(s)/millilitre

药物剂型:

Concentrate for solution for infusion

治疗领域:

Platinum compounds; cisplatin

授权状态:

Not marketed

授权日期:

2014-05-02

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 1 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
•
Simultaneous use of medicines that inhibit the BONE MARROW
function or radiation can potentiate the adverse effects of
FERTILITY
MALE PATIENTS treated with cisplatin are advised not to father a child
during treatment and for up to 6 months after treatment. Further,
male patients should seek advice regarding cryoconservation of
sperm prior to treatment with Cisplatin.
The following side effects may occur:
VERY COMMON: MAY AFFECT MORE THAN 1 IN 10 PEOPLE
•
reduction in the number of white blood cells which makes
infections more likely (leukopenia)
THE FOLLOWING INFORMATION IS
INTENDED FOR HEALTHCARE PROFESSIONALS
ONLY:
PREPARATION AND HANDLING OF THE
PRODUCT
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
cisplatin on the bone marrow.
If you are pregnant or breast-feeding, think you may be pregnant
•
reduction in blood platelets which increases the risk of bruising
− 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

产品特点

Health Products Regulatory Authority
05 April 2019
CRN008RV3
Page 1 of 12
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 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.