Potactasol

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

topotecan

Available from:

Actavis Group PTC ehf

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

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).

Product summary:

Revision: 11

Authorization status:

Authorised

Authorization date:

2011-01-06

Patient Information leaflet

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
POTACTASOL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
POTACTASOL 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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Potactasol is and what it is used for
2.
What you need to know before you use Potactasol
3.
How to use Potactasol
4.
Possible side effects
5.
How to store Potactasol
6.
Contents of the pack and other information
1.
WHAT POTACTASOL IS AND WHAT IT IS USED FOR
Potactasol contains the active substance topotecan which helps to kill
tumour cells.
Potactasol is used to treat:
-
ovarian cancer or small cell lung cancer that has come back after
chemotherapy
-
advanced cervical cancer if surgery or radiotherapy is not possible.
In this case Potactasol
treatment is combined with medicines containing cisplatin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE POTACTASOL
DO NOT USE POTACTASOL
-
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 YOU DOCTOR
if you think any of these could apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Potactasol:
-
if you have any kidney problems. Your dose of Potactasol may need to
be adjusted. Potactasol is
not recommended in case of severe kidney impairment;
-
if you have liver problems. Potactasol is not recommended in case of
severe liver impairment;
-
if you suffer from lung inflammation with signs such as cough, fever
and difficulties in

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Potactasol 1 mg powder for concentrate for solution for infusion
Potactasol 4 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Potactasol 1 mg powder for concentrate for solution for infusion
Each vial contains 1 mg topotecan (as hydrochloride).
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Excipient with known effect
Each vial contains 0.52 mg (0.0225 mmol) sodium.
Potactasol 4 mg powder for concentrate for solution for infusion
Each vial contains 4 mg topotecan (as hydrochloride).
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Excipient with known effect
Each vial contains 2.07 mg (0.09 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Yellow lyophilisate.
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 firs