Topotecan Accord 1 mg/ml concentrate for solution for infusion (4ml vial)

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

TOPOTECAN

متاح من:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC رمز:

L01XX17

INN (الاسم الدولي):

TOPOTECAN 1 mg/ml

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

TOPOTECAN 1 mg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTINEOPLASTIC AGENTS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2012-03-02

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN ACCORD 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
TOPOTECAN
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 or your pharmacist.
-
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 Topotecan Accord is and what it is used for
2.
What you need to know before you are given Topotecan Accord
3.
How to use Topotecan Accord
4.
Possible side effects
5.
How to store Topotecan Accord
6.
Contents of the pack and other information
1.
WHAT TOPOTECAN ACCORD IS AND WHAT IT IS USED FOR
Topotecan Accord helps to destroy tumours. A doctor or a nurse will
give you the medicine as an
infusion into a vein (a drip) in hospital.
Topotecan Accord is used to treat:
-
ovarian cancer or small cell lung cancer that has come back after
chemotherapy
-
advanced cervical cancer if surgery or radiotherapy treatment is not
possible. When treating
cervical cancer, Topotecan Accord is combined with another medicine
called cisplatin.
Your doctor will decide with you whether Topotecan Accord therapy is
better than further treatment
with your initial chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TOPOTECAN ACCORD
YOU SHOULD NOT RECEIVE TOPOTECAN ACCORD:
-
if you are allergic to topotecan or any of the other ingredients of
this medicine (listed in section
6).
-
if you are breast feeding
-
if your blood cell counts are too low. Your doctor will tell you
whether this is the case, based on
the results of your last blood test.
TELL YOUR DOCTOR
if any of these applies to you.
WARNING AND PRECAUTIONS
Talk to you doctor or pharmacist or nurse before you are given this
medicine:
-
if you have any kidney or liver problems. Your dose of Topotecan
Accord may need to be
adjusted.
-
if you

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topotecan Accord 1 mg/ml concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg topotecan
(as hydrochloride).
Each 1 ml vial of concentrate contains 1 mg topotecan (as
hydrochloride)
Each 4 ml vial of concentrate contains 4 mg topotecan (as
hydrochloride)
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear yellow colour solution free from visible foreign particles. pH
in the range of 1.5 to
2.5 and Osmolarity in the range of approximately 100 to 40 mOsm/Litre.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topotecan monotherapy is indicated for the treatment of:
• Patients with metastatic carcinoma of the ovary after failure of
first-line or subsequent
therapy.
• Patients with relapsed small cell lung cancer [SCLC] for whom
re-treatment with the first-
line regimen is not considered appropriate (see section 5.1).
Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the
cervix recurrent after radiotherapy and for patients with Stage IVB
disease. Patients with
prior exposure to cisplatin require a sustained treatment free
interval to justify treatment
with the combination (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of topotecan should be confined to units specialised in the
administration of
cytotoxic chemotherapy. Topotecan should only be administered under
the supervision of a
physician experienced in the use of chemotherapy (see section 6.6).
POSOLOGY
When topotecan is used in combination with cisplatin, the full
prescribing information for
cisplatin should be consulted.
2
Prior to administration of the first course of topotecan, patients
must have a baseline
neutrophil count of
1.5 x 10
9
/l, a platelet count of
100 x 109/l and a haemoglobin level of
≥ 9 g/dl (after transfusion if necessary).
_OVARIAN AND SMALL CELL LUNG CARCINOMA