Evoltra

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

clofarabine

Διαθέσιμο από:

Sanofi B.V.

Φαρμακολογική κατηγορία (ATC):

L01BB06

INN (Διεθνής Όνομα):

clofarabine

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Θεραπευτικές ενδείξεις:

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.

Περίληψη προϊόντος:

Revision: 33

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-05-29

Φύλλο οδηγιών χρήσης

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOLTRA 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
clofarabine
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.
•
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Evoltra is and what it is used for
2.
What you need to know before you use Evoltra
3.
How to use Evoltra
4.
Possible side effects
5.
How to store Evoltra
6.
Contents of the pack and other information
1.
WHAT EVOLTRA IS AND WHAT IT IS USED FOR
Evoltra contains the active substance clofarabine. Clofarabine is one
of a family of medicines called
anticancer medicines. It works by hindering the growth of abnormal
white blood cells, and eventually
kills them. It works best against cells which are multiplying quickly
– such as cancer cells.
Evoltra is used to treat children (≥ 1 year old), teenagers and
young adults up to 21 years old with
acute lymphoblastic leukaemia (ALL) when previous treatments have not
worked or have stopped
working. Acute lymphoblastic leukaemia is caused by abnormal growth of
some types of white blood
cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EVOLTRA
DO NOT USE EVOLTRA
-
IF YOU ARE ALLERGIC
to clofarabine or any of the other ingredients of this medicine
(listed in
section 6);
-
IF YOU ARE BREAST-FEEDING
(please read the section “Pregnancy and breast-feeding” below);
-
IF YOU HAVE SEVE

Αρχείο Π.Χ.Π.

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
Evoltra 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 1 mg of clofarabine.
Each 20 ml vial contains 20 mg of clofarabine.
Excipient
with known effect
Each 20 ml vial contains 180 mg of sodium chloride, which is
equivalent to 3.6 mg of sodium per ml
(0.2 mmol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, practically colourless solution with a pH of 4.5 to 7.5 and an
osmolarity of 270 to 310 mOsm/l.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric
patients who have relapsed or are
refractory after receiving at least two prior regimens and where there
is no other treatment option
anticipated to result in a durable response. Safety and efficacy have
been assessed in studies of
patients ≤ 21 years old at initial diagnosis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy must be initiated and supervised by a physician experienced in
the management of patients
with acute leukaemias.
Posology
_ _
_Adult population (_
_including elderly) _
There are currently insufficient data to establish the safety and
efficacy of clofarabine in adult patients
(see section 5.2).
_Paediatric population _
_ _
_Children and adolescents (≥ 1 year old) _
The recommended dose in monotherapy is 52 mg/m
2
of body surface area administered by intravenous
infusion over 2 hours daily for 5 consecutive days. Body surface area
must be calculated using the
actual height and weight of the patient before the start of each
cycle. Treatment cycles should be
repeated every 2 to 6 weeks