TEPADINA 15 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

THIOTEPA

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

L01AC01

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

THIOTEPA 15 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

RIEMSER PHARMA GMBH, GERMANY

Therapeutic area:

THIOTEPA

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.

Authorization date:

2015-07-28

Patient Information leaflet

.תשפיחש המ תא ונאצמ אל
הנוכנ תנזהש תבותכה םא קודבל יאדכ
תבותכב עייסל חמשנ
[e-mail]
(
1
)

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
TEPADINA 15 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
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.
2
_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
2
(24.32 mg/kg), during
the time of the entire conditioning treatment.
_ _
LYMPHOMA
The recommended dose ranges from 125