TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Treosulfan

Dostępny od:

LINK HEALTHCARE SINGAPORE PTE LTD

Kod ATC:

L01AB02

Forma farmaceutyczna:

INJECTION, POWDER, FOR SOLUTION

Skład:

Treosulfan 1 g / vial

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Oncotec Pharma Produktion GmbH

Status autoryzacji:

ACTIVE

Data autoryzacji:

2023-12-26

Charakterystyka produktu

spc
multiple (SG-English) Trecondi 1 g/ 5 g powder for solution for
infusion
National Version: 12/2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trecondi 1 g powder for solution for infusion
Trecondi 5 g powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trecondi 1 g powder for solution for infusion
One vial contains 1 g of treosulfan.
Trecondi 5 g powder for solution for infusion
One vial contains 5 g of treosulfan.
When reconstituted according to section 6.6, 1 mL of the solution for
infusion contains 50 mg
treosulfan.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treosulfan in combination with fludarabine is indicated as part of
conditioning treatment prior to
allogeneic haematopoietic stem cell transplantation (alloHSCT) in
adult patients with acute myeloid
leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk of
toxicity with standard
conditioning therapies, and in paediatric patients older than one
month with malignant diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of treosulfan should be supervised by a physician
experienced in conditioning
treatment followed by alloHSCT.
Posology
_ _
_Adults with AML and MDS _
_ _
Treosulfan is given in combination with fludarabine.
The recommended dose and schedule of administration is:
•
Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour
intravenous infusion, given
on three consecutive days (day -4, -3, -2) before stem cell infusion
(day 0). The total treosulfan
dose is 30 g/m²;
•
Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion,
given on five
consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion
(day 0). The total fludarabine
dose is 150 mg/m²;
•
Treosulfan should be administered before fludarabine on days -4, -3,
-2 (FT
10
regimen).
spc
multiple (SG-English) Trecondi 1 g/ 5 g powder for solution for
infusion
National Version: 12/2023
_Elder