Busulfan Fresenius Kabi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-05-2021
Valmisteyhteenveto
(SPC)
18-05-2021
Julkisesta arviointikertomuksesta
(PAR)
21-04-2015
Aktiivinen ainesosa:
busulfan
Saatavilla:
Fresenius Kabi Deutschland GmbH
ATC-koodi:
L01AB01
INN (Kansainvälinen yleisnimi):
busulfan
Terapeuttinen ryhmä:
Alkyl sulfonates
Terapeuttinen alue:
Hematopoietic Stem Cell Transplantation
Käyttöaiheet:
Busulfan Fresenius Kabi 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.Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Tuoteyhteenveto:
Revision: 9
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-09-22
Pakkausseloste
29
B.
PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUSULFAN FRESENIUS KABI 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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Busulfan Fresenius Kabi is and what it is used for
2.
What you need to know before you use Busulfan Fresenius Kabi
3.
How to use Busulfan Fresenius Kabi
4.
Possible side effects
5
How to store Busulfan Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT BUSULFAN FRESENIUS KABI IS AND WHAT IT IS USED FOR
This medicine contains the active substance busulfan, which belongs to
a group of medicines called
alkylating agents. Busulfan Fresenius Kabi destroys the original bone
marrow before the transplant.
Busulfan Fresenius Kabi is used in adults, new-born infants, children
and adolescents as a
TREATMENT
PRIOR TO TRANSPLANTATION.
In adults Busulfan Fresenius Kabi is used in combination with
cyclophosphamide or fludarabine.
In new-born infants, children and adolescents, this medicine 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 BUSULFAN
FRESENIUS KABI
DO NOT USE
BUSULFAN FRESENIUS KABI:
-
if you are allergic to busulfan or any of the other ingredients of
this medicine listed in section 6.
-
if you are pregnant, or think you may be pregnant.
WARNINGS AND PRECAUTIONS
Busulfan Fresenius Kabi 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
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Busulfan Fresenius Kabi 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 viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Busulfan 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.
Busulfan 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.
Busulfan 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
Busulfan administration should be supervised by a physician
experienced in conditioning treatment
prior to haematopoietic progenitor cell transplantation.
Busulfan is administered prior to the haematopoietic progenitor cell
transplantation (HPCT).
Posology
_Busulfan 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 16
th
dose of busulfan (see section 4.5).
_Paediatric population (0 to 17 years)_
The recommended dose of busulfan is as follows:
3
Actual body weight (kg)
Busulfan dose (mg/kg)
<
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