Tepadina

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

thiotepa

Saatavilla:

ADIENNE S.r.l. S.U.

ATC-koodi:

L01AC01

INN (Kansainvälinen yleisnimi):

thiotepa

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Hematopoietic Stem Cell Transplantation

Käyttöaiheet:

In combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-03-15

Pakkausseloste

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEPADINA 15 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
thiotepa
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 TEPADINA is and what it is used for
2.
What you need to know before you use TEPADINA
3.
How to use TEPADINA
4.
Possible side effects
5.
How to store TEPADINA
6.
Contents of the pack and other information
1.
WHAT TEPADINA IS AND WHAT IT IS USED FOR
TEPADINA contains the active substance thiotepa, which belongs to a
group of medicines called
alkylating agents.
TEPADINA is used to prepare patients for bone marrow transplantation.
It works by destroying bone
marrow cells. This enables the transplantation of new bone marrow
cells (haematopoietic progenitor
cells), which in turn enable the body to produce healthy blood cells.
TEPADINA can be used in adults and children and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TEPADINA
DO NOT USE TEPADINA
-
if you are allergic to thiotepa,
-
if you are pregnant or think you may be pregnant,
-
if you are breast-feeding,
-
if you are receiving yellow fever vaccination, live virus and
bacterial vaccines.
WARNING AND PRECAUTIONS
You should tell your doctor if you have:
-
liver or kidney problems,
-
heart or lung problems,
-
seizures/fits (epilepsy) or have had them in the past (if treated with
phenytoin or fosphenytoin).
Because TEPADINA destroys bone marrow cells responsible for producing
blood cells, regular blood
tests will be taken during treatment to check your blood cell counts.
In order to prevent and manage infections, you will be given
anti-infectives.
TEPADINA may cause another type of cancer in the future. Your doctor
will discuss this ri

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
TEPADINA 15 mg powder for concentrate for solution for infusion
TEPADINA 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TEPADINA 15 mg powder for concentrate for solution for infusion
One vial of powder contains 15 mg thiotepa.
After reconstitution with 1.5 mL of water for injections, each mL of
solution contains 10 mg thiotepa
(10 mg/mL).
TEPADINA 100 mg powder for concentrate for solution for infusion
One vial of powder contains 100 mg thiotepa.
After reconstitution with 10 mL of water for injections, each mL of
solution contains 10 mg thiotepa
(10 mg/mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White crystalline powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TEPADINA is indicated, in combination with other chemotherapy
medicinal products:
•
with or without total body irradiation (TBI), as conditioning
treatment prior to allogeneic or
autologous haematopoietic progenitor cell transplantation (HPCT) in
haematological diseases in adult
and paediatric patients;
•
when high dose chemotherapy with HPCT support is appropriate for the
treatment of solid
tumours in adult and paediatric patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TEPADINA administration must be supervised by a physician experienced
in conditioning treatment
prior to haematopoietic progenitor cell transplantation.
Posology
TEPADINA is administered at different doses, in combination with other
chemotherapeutic medicinal
products, in patients with haematological diseases or solid tumours
prior to HPCT.
TEPADINA posology is reported, in adult and paediatric patients,
according to the type of HPCT
(autologous or allogeneic) and disease.
_ _
_Adults _
_ _
_AUTOLOGOUS HPCT _
_ _
_Haematological diseases _
3
_ _
The recommended dose in haematological diseases ranges from 125 mg/m
2
/day (3.38 mg/kg/day) to
300 mg/m
2
/da