CISPLATIN 1 Mg/Ml Concentrate for Soln for Inf

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

CISPLATIN

Sẵn có từ:

Caduceus Pharma Ltd

Mã ATC:

L01XA01

INN (Tên quốc tế):

CISPLATIN

Liều dùng:

1 Mg/Ml

Dạng dược phẩm:

Concentrate for Soln for Inf

Loại thuốc theo toa:

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

Khu trị liệu:

Platinum compounds

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2013-10-25

Tờ rơi thông tin

1
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 TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. 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
CISPLATIN 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 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.
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 USE CISPLATIN:
-
if you are allergic to cisplatin or any of the other ingredients of
this medicine (listed in section
6)
-
if you are allergic to any other medicine that contains platinum
compounds
-
if you have kidney problems (renal dysfunction)
-
if you suffer from dehydration
-
if you suffer from severe suppression of bone marrow functionality,
symptoms may be extreme
tiredness, easy bruising or bleeding, occurrence of infections
-
if your hearing

Đặc tính sản phẩm

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 50 ml concentrate for
solution for infusion contains 50 mg of cisplatin.
Excipient with known effect:
Each ml of solution contains 3.5 mg (< 1mmol) of sodium (see section
4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, slightly yellow solution free from visible particles.
The pH is between 3.5 and 6.5.
The osmolarity is 287 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
Cisplatin 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:_
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
dosage directions are applicable for bot