Enrylaze

البلد: الاتحاد الأوروبي

اللغة: الإنجليزية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

crisantaspase

متاح من:

Jazz Pharmaceuticals Ireland Limited

ATC رمز:

L01XX02

INN (الاسم الدولي):

crisantaspase

المجموعة العلاجية:

Antineoplastic agents

المجال العلاجي:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

الخصائص العلاجية:

Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.

الوضع إذن:

Authorised

تاريخ الترخيص:

2023-09-15

نشرة المعلومات

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENRYLAZE 10 MG/0.5 ML SOLUTION FOR INJECTION/INFUSION
recombinant crisantaspase
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 RECEIVING 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 Enrylaze is and what it is used for
2.
What you need to know before you are given Enrylaze
3.
How Enrylaze is given
4.
Possible side effects
5.
How Enrylaze is stored
6.
Contents of the pack and other information
1.
WHAT ENRYLAZE IS AND WHAT IT IS USED FOR
Enrylaze contains the active substance recombinant crisantaspase. It
is a medicine used alongside
other medicines to treat acute lymphoblastic leukaemia (ALL) and
lymphoblastic lymphoma (LBL).
Enrylaze can be given to patients aged 1 months of age or older.
Enrylaze contains a protein made in the laboratory by recombinant DNA
technology. This protein
works by decreasing the amount of a protein called asparagine. This
protein is needed by the ALL and
LBL cancer cells to survive.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ENRYLAZE
_ _
YOU SHOULD NOT RECEIVE ENRYLAZE
•
if you have a severe allergic reaction to Enrylaze.
•
if you have an allergic reaction to any of the other ingredients of
this medicine (listed in
section 6).
•
if you are currently experiencing severe pancreatitis (inflammation of
the pancreas).
•
i

خصائص المنتج

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
Enrylaze 10 mg/0.5 mL solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 0.5 mL solution of 10 mg of recombinant
crisantaspase*
The amino acid sequence is identical to native L-asparaginase from
_Erwinia chrysanthemi_
(also
known as crisantaspase).
An
_in-vitro_
activity assay demonstrated that 1 mg of recombinant crisantaspase
approximates 1 000 U
of native crisantaspase, consistent with the
_in-vivo_
comparisons from clinical trials. Serum
asparaginase activity (SAA) exposures (C
max
, concentration at 48h & 72h and AUC) have been shown
to be comparable for 25 mg/m
2
recombinant crisantaspase and 25 000 U/m
2
native crisantaspase, when
administered intravenously or intramuscularly in healthy subjects.
*recombinant
_Erwinia chrysanthemi_
L-asparaginase produced in
_Pseudomonas fluorescens_
by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear to opalescent, colourless to slightly yellow solution with a pH
of 7.0 ± 0.5 and an osmolality:
290–350 mOsmol/Kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enrylaze is indicated as a component of a multi-agent chemotherapeutic
regimen for the treatment of
acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL)
in adult and paediatric
patients (1 month and older) who developed hypersensitivity or silent
inactivation to
_E. coli_
-derived
asparaginase.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Enrylaze should be prescribed and administered by physicians and
healthcare personnel experienced in
the use of antineoplastic products. Appropriate resuscitation
equipment and other agents necessary