Topotecan Accord 1mg/ml concentrate for solution for infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Topotecan (as hydrochloride)

Διαθέσιμο από:

Accord Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

L01XX; L01XX17

INN (Διεθνής Όνομα):

Topotecan (as hydrochloride)

Δοσολογία:

1 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Concentrate for solution for infusion

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Other antineoplastic agents; topotecan

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2012-05-04

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN 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,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 1 mg/ml concentrate for
solution for infusion is and what it is used for
2. What you need to know before you are given
Topotecan 1 mg/ml concentrate for solution for
infusion
3. How to use Topotecan 1 mg/ml concentrate for
solution for infusion
4. Possible side effects
5. How to store Topotecan 1 mg/ml concentrate
for solution for infusion
6. Contents of the pack and other information 1.
WHAT TOPOTECAN 1 MG/ML
CONCENTRATE FOR SOLUTION FOR
INFUSION IS AND WHAT IT IS
USED FOR
Topotecan 1 mg/ml concentrate for solution for
infusion 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 1 mg/ml concentrate for solution for
infusion 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 1 mg/ml
concentrate for solution for infusion is combined
with another medicine called cisplatin.
Your doctor will decide with you whether
Topotecan 1 mg/ml concentrate for solution for
infusion therapy is better than further treatment
with your initial chemotherapy. 2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN TOPOTECAN
1 MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
YOU SHOULD NOT RECEIVE TOPOTECAN 1 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION:
-
if you are allergic to topotecan or any of the
other ingredients of this medicine (listed in
section 6).
-
i

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topotecan Accord 1mg/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.
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).
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