Busilvex
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-08-2023
Charakterystyka produktu
(SPC)
04-08-2023
Sprawozdanie z oceny publicznego
(PAR)
04-08-2023
Składnik aktywny:
busulfan
Dostępny od:
Pierre Fabre Medicament
Kod ATC:
L01AB01
INN (International Nazwa):
busulfan
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Hematopoietic Stem Cell Transplantation
Wskazania:
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Withdrawn
Data autoryzacji:
2003-07-09
Ulotka dla pacjenta
30
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUSILVEX 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION.
busulfan.
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Busilvex is and what it is used for
2.
What you need to know before you use Busilvex
3.
How to use Busilvex
4.
Possible side effects
5
How to store Busilvex
6.
Contents of the pack and other information
1.
WHAT BUSILVEX IS AND WHAT IT IS USED FOR
Busilvex contains the active substance busulfan, which belongs to a
group of medicines called
alkylating agents. Busilvex destroys the original bone marrow before
the transplant.
Busilvex is used in adults, new-born infants, children and adolescents
as a
TREATMENT PRIOR TO
TRANSPLANTATION.
In adults Busilvex is used in combination with cyclophosphamide or
fludarabine.
In new-born infants, children and adolescents, Busilvex is used in
combination with
cyclophosphamide or melphalan.
You will receive this preparative medicine before receiving a
transplant of either bone marrow or
haematopoietic progenitor cell.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUSILVEX
DO NOT USE BUSILVEX:
−
if you are allergic to busulfan or any of the other ingredients of
Busilvex listed in section 6,
−
if you are pregnant, or think you may be pregnant.
WARNINGS AND PRECAUTIONS
Busilvex is a potent cytotoxic medicine that results in profound
decrease of blood cells. At the
recommended dose, this is the desired effect. Therefore careful
monitoring will be performed.
It is possible that use of Busilvex may increase the risk of suffering
another malignancy in the future.
You should tell your doctor:
−
if you have a liver, kidney, heart or lung problem
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Busilvex 6 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
After dilution: 1 ml of solution contains 0.5 mg of busulfan
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Busilvex followed by cyclophosphamide (BuCy2) is indicated as
conditioning treatment prior to
conventional haematopoietic progenitor cell transplantation (HPCT) in
adult patients when the
combination is considered the best available option.
Busilvex following fludarabine (FB) is indicated as conditioning
treatment prior to haematopoietic
progenitor cell transplantation (HPCT) in adult patients who are
candidates for a reduced-intensity
conditioning (RIC) regimen.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is
indicated as conditioning
treatment prior to conventional haematopoietic progenitor cell
transplantation in paediatric patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Busilvex administration should be supervised by a physician
experienced in conditioning treatment
prior to haematopoietic progenitor cell transplantation.
Busilvex is administered prior to the haematopoietic progenitor cell
transplantation (HPCT).
Posology
_Busilvex in combination with cyclophosphamide or melphalan_
_In adults _
The recommended dose and schedule of administration is:
-
0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6
hours over
4 consecutive days for a total of 16 doses,
-
followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for
at least 24 hours
following the 16th dose of Busilvex (see section 4.5).
Medicinal product no longer authorised
3
_Paediatric population (0 to 17 years) _
The recommended dose of Busilvex is as f
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