Atriance
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
08-12-2023
Produktets egenskaber
(SPC)
08-12-2023
Offentlige vurderingsrapport
(PAR)
22-01-2020
Aktiv bestanddel:
nelarabine
Tilgængelig fra:
Sandoz Pharmaceuticals d.d.
ATC-kode:
L01BB07
INN (International Name):
nelarabine
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Terapeutiske indikationer:
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.,
Produkt oversigt:
Revision: 26
Autorisation status:
Authorised
Autorisation dato:
2007-08-22
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATRIANCE 5 MG/ML SOLUTION FOR INFUSION
nelarabine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Atriance is and what it is used for
2.
What you need to know before you are given Atriance
3.
How Atriance is given
4.
Possible side effects
5.
How to store Atriance
6.
Contents of the pack and other information
1.
WHAT ATRIANCE IS AND WHAT IT IS USED FOR
Atriance contains nelarabine which belongs to a group of medicines
known as
_antineoplastic agents,_
used in chemotherapy to kill some types of cancer cells.
ATRIANCE IS USED TO TREAT PATIENTS WITH:
•
a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Leukaemia causes an
abnormal increase in the number of white blood cells. The abnormal
high number of white
blood cells can appear in the blood and other parts of the body. The
type of leukaemia relates to
the type of white blood cell mainly involved. In this case, its cells
are called lymphoblasts.
•
a type of lymphoma, called T-cell lymphoblastic lymphoma. This
lymphoma is caused by a
mass of lymphoblasts, a type of white blood cell.
If you have any questions about your illness, talk to your doctor
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ATRIANCE
YOU (OR YOUR CHILD, IF HE/SHE IS BE
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Atriance 5 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 5 mg of nelarabine.
Each vial contains 250 mg of nelarabine.
Excipient with known effect
Each ml of solution contains 1.770 mg (77 micromols) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nelarabine is indicated for the treatment of patients with T-cell
acute lymphoblastic leukaemia
(T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has
not responded to or has
relapsed following treatment with at least two chemotherapy regimens.
Due to the small patient populations in these disease settings, the
information to support these
indications is based on limited data.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nelarabine must only be administered under the supervision of a
physician experienced in the use of
cytotoxic agents.
Posology
Complete blood counts including platelets must be monitored regularly
(see sections 4.4 and 4.8).
_Adults and adolescents (aged 16 years and older) _
The recommended dose of nelarabine for adults and adolescents aged 16
years and older is
1,500 mg/m
2
administered intravenously over two hours on days 1, 3 and 5 and
repeated every
21 days.
_Children and adolescents (aged 21 y_
_ears and younger) _
The recommended dose of nelarabine for children and adolescents (aged
21 years and younger) is
650 mg/m
2
administered intravenously over one hour daily for 5 consecutive days,
repeated every
3
21 days.
In clinical studies, the 650 mg/m
2
and 1,500 mg/m
2
dose have both been used in patients in the age
range
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