Trecondi

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Treosulfan

Saatavilla:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC-koodi:

L01AB02

INN (Kansainvälinen yleisnimi):

treosulfan

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Hematopoietic Stem Cell Transplantation

Käyttöaiheet:

Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-06-20

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRECONDI 1 G POWDER FOR SOLUTION FOR INFUSION
TRECONDI 5 G POWDER FOR SOLUTION FOR INFUSION
treosulfan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trecondi is and what it is used for
2.
What you need to know before you are given Trecondi
3.
How to use Trecondi
4.
Possible side effects
5.
How to store Trecondi
6.
Contents of the pack and other information
1.
WHAT TRECONDI IS AND WHAT IT IS USED FOR
Trecondi contains the active substance treosulfan, which belongs to a
group of medicines called
alkylating agents. Treosulfan is used to prepare patients for bone
marrow transplant (haematopoietic
stem cell transplantation). Treosulfan destroys the bone marrow cells
and enables the transplant of new
bone marrow cells which leads to the production of healthy blood
cells.
Trecondi is used as a
TREATMENT BEFORE BLOOD STEM CELL TRANSPLANTATION
in adults and in adolescents
and children older than one month with cancer and non-cancerous
disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRECONDI
TRECONDI MUST NOT BE GIVEN TO YOU

if you are allergic to treosulfan,

if you suffer from an active uncontrolled infection,

if you suffer from severe heart, lung, liver or kidney diseases,

if you suffer from hereditary DNA repair disorder, a condition that
reduces the ability to repair
DNA (which carries your genetic information),

if you are pregnant, or think you may be pregnant.
WARNINGS AND PRECAUTIONS
Trecondi is a cell-killing (cytotoxic) medicine that is used to
decrease the number of blood cells. At
the recommended dose, this is the desired effec

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 of powder contains 1 g of treosulfan.
Trecondi 5 g powder for solution for infusion
One vial of powder 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 and in paediatric
patients older than one month with malignant and non-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 malignant disease _
_ _
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).
_Adults with non-malignant disease _
_ _
Treosulfan is given in combination with fludarabine with or without
thiotepa.
The recommended dose and schedule of administration is:
3
•
Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour
intravenous infusion, given
on three consecuti