TEPADINA 100 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

THIOTEPA

Prieinama:

MBI PHARMA LTD., ISRAEL

ATC kodas:

L01AC01

Vaisto forma:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

THIOTEPA 100 MG

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

RIEMSER PHARMA GMBH, GERMANY

Gydymo sritis:

THIOTEPA

Terapinės indikacijos:

TEPADINA is indicated, in combination with other chemotherapy medicinal products:1. 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;2. when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Leidimo data:

2015-07-28

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Prekės savybės

The format of this leaflet was determined by the Ministry of Health
and its content was
checked and approved by it on 09.03.2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TEPADINA 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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:
1. 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;
2. 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 _
_ _
The recommended dose in haematological diseases ranges from 125 mg/m
2
/day (3.38
mg/kg/day) to
300 mg/m
2
/day (8.10 mg/kg/day) as a single daily infusion, administered from 2
up to 4
consecutive days before autologous HPCT depending on the combination
with other
chemotherapeutic medicinal products, without exceeding the total
maximum cumulative dose of
900 mg/m