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

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

TOPOTECAN

Disponible des:

Accord Healthcare Limited

Codi ATC:

L01XX17

Designació comuna internacional (DCI):

TOPOTECAN

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

TOPOTECAN 1 mg/ml

tipo de receta:

POM

Área terapéutica:

ANTINEOPLASTIC AGENTS

Estat d'Autorització:

Authorised

Informació per a l'usuari

Page 1 of 7
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 taking this
medicine because it contains important
information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or your 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 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
WHAT TOPOTECAN ACCORD IS:
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.
WHAT TOPOTECAN ACCORD IS USED FOR:
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 drug 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
DO NOT TAKE TOPOTECAN ACCORD:
-
if you are allergic (hypersensitive) to topotecan or any of the other
ingredients of Topotecan
Accord (listed in section 6).
-
if you are breast feeding
-
if your blood cell counts are too low. Your doctor will tell you,
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

Fitxa tècnica

Page 1 of 14
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
POSOLOGY
When used in combination with cisplatin, the full prescribing
information for cisplatin
should be consulted.
Page 2 of 14
Prior to administration of the first course of topotecan, patients
must have a baseline
neutrophil count of
1.5 x 10
9
/l, and 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 _
_ _
_INITIAL DOSE _
The recommended dose of topotecan is 1.5 mg/m
2
body surface area/day administered by
intravenous infusion over 30 minutes daily for 5 consecutive days with
a 3 week interval
between the start of each course.