TEPADINA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 15MGVIAL

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

Thiotepa

Inapatikana kutoka:

AXXESSBIO PTE. LTD.

ATC kanuni:

L01AC01

Dawa fomu:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Tungo:

Thiotepa 15mg/vial

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

Prescription Only

Viwandani na:

BSP Pharmaceuticals S.p.A

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2022-07-18

Tabia za bidhaa

Tepadina 15-100 mg
ISTRUZIONE
330001630
10
NERO
1
360 x 735
Tipo di materiale
Descrizione
Formato
N°. colori
Colore 2
GRAMMATURA CARTA
TACCHE LAETUS
DATA IMPIANTO
Corpo
Colore 1
PELLICOLA DI PROPRIETÀ
VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA
27-07-22
Cod. 00359/1
Destinazione
Paese
Codice:
Helvetica
Neue LT Std
FONT
SINGAPORE
SUMMARY OF PRODUCT CHARACTERISTICS
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 breast cancer in adult patients and
CNS tumours in 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 soli