Hycamtin

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

topotecan

Beschikbaar vanaf:

Sandoz Pharmaceuticals d.d.

ATC-code:

L01CE01

INN (Algemene Internationale Benaming):

topotecan

Therapeutische categorie:

Antineoplastic agents

Therapeutisch gebied:

Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

therapeutische indicaties:

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Product samenvatting:

Revision: 39

Autorisatie-status:

Authorised

Autorisatie datum:

1996-11-12

Bijsluiter

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYCAMTIN 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
HYCAMTIN 4 MG POWDER FOR 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.
•
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 Hycamtin is and what it is used for
2.
What you need to know before you are given Hycamtin
3.
How Hycamtin is used
4.
Possible side effects
5.
How to store Hycamtin
6.
Contents of the pack and other information
1.
WHAT HYCAMTIN IS AND WHAT IT IS USED FOR
Hycamtin helps to destroy tumours. A doctor or a nurse will give you
the medicine as an infusion into
a vein in hospital.
HYCAMTIN 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, Hycamtin is combined with another medicine called
cisplatin.
Your doctor will decide with you whether Hycamtin therapy is better
than further treatment with your
initial chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYCAMTIN
YOU SHOULD NOT RECEIVE HYCAMTIN
•
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.
WARNINGS AND PRECAUTIONS
Before you are given this medicine your doctor needs to know:
•
if you have any kidney or liver problems. Your dose of Hycamtin may
need to be adjusted.
•
if you are pregnant or plan to become pregnant. See sect

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HYCAMTIN 1 mg powder for concentrate for solution for infusion
HYCAMTIN 4 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
HYCAMTIN 1 mg powder for concentrate for solution for infusion
Each vial contains 1 mg topotecan (as hydrochloride).
The total content of active substance in the vial provides 1 mg per ml
of active substance when
reconstituted as recommended.
HYCAMTIN 4 mg powder for concentrate for solution for infusion
Each vial contains 4 mg topotecan (as hydrochloride).
The total content of active substance in the vial provides 1 mg per ml
of active substance when
reconstituted as recommended.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Light yellow to greenish powder.
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.
3
Prior to administration of the first course of topotecan,