Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
THIOTEPA
A.L. MEDI-MARKET LTD.
L01AC01
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
THIOTEPA 100 MG/VIAL
I.V
Required
HWI DEVELOPMENT GMBH
THIOTEPA
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.
2022-01-13
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 Διαβάστε το πλήρες έγγραφο