THIOTEPA RIEMSER 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

THIOTEPA

متاح من:

A.L. MEDI-MARKET LTD.

ATC رمز:

L01AC01

الشكل الصيدلاني:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

THIOTEPA 100 MG/VIAL

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HWI DEVELOPMENT GMBH

المجال العلاجي:

THIOTEPA

الخصائص العلاجية:

THIOTEPA RIEMSER 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.

تاريخ الترخيص:

2022-01-13

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thiotepa Riemser 15 mg powder for concentrate for solution for
infusion
Thiotepa Riemser 100 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiotepa Riemser 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).
Thiotepa Riemser 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
Thiotepa Riemser 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
Thiotepa Riemser administration must be supervised by a physician
experienced in conditioning
treatment prior to haematopoietic progenitor cell transplantation.
Posology
Thiotepa Riemser is administered at different doses, in combination
with other chemotherapeutic
medicinal products, in patients with haematological diseases or solid
tumours prior to HPCT.
Thiotepa Riemser 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