Oncaspar
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
28-11-2018
Данни за продукта
(SPC)
28-11-2018
Доклад обществена оценка
(PAR)
15-12-2017
Активна съставка:
pegaspargase
Предлага се от:
Baxalta Innovations GmbH
АТС код:
L01XX24
INN (Международно Name):
pegaspargase
Терапевтична група:
Antineoplastic agents,
Терапевтична област:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Терапевтични показания:
Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.,
Каталог на резюме:
Revision: 6
Статус Оторизация:
Authorised
Дата Оторизация:
2016-01-14
Листовка
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONCASPAR 750 U/ML SOLUTION FOR INJECTION/INFUSION
pegaspargase
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 ARE GIVEN 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 Oncaspar is and what it is used for
2.
What you need to know before you are given Oncaspar
3.
How Oncaspar is given
4.
Possible side effects
5.
How to store Oncaspar
6.
Contents of the pack and other information
1.
WHAT ONCASPAR IS AND WHAT IT IS USED FOR
Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that
breaks down asparagine, an
important building block of proteins without which cells cannot
survive. Normal cells can make
asparagine for themselves, while some cancer cells cannot. Oncaspar
lowers asparagine level in blood
cancer cells and stops the cancer cells growing.
Oncaspar is used to treat acute lymphoblastic leukaemia (ALL) in
children from birth to 18 years and
adults. ALL is a white blood cell cancer type in which certain
immature white cells (named
lymphoblasts) start growing out of control thus preventing the
production of functional blood cells.
Oncaspar is used together with other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ONCASPAR
DO NOT USE ONCASPAR:
-
if you are allergic to pegaspargase or to any of the other ingredients
of this medicine (listed in
section 6).
-
if you ever had pancreatitis.
-
if you ever had severe bleeding following asparaginase therapy.
-
if you ever had blood clots following asparaginase therapy.
Tell yo
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Данни за продукта
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
Oncaspar 750 U/ml solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 750 Units (U)** of pegaspargase*.
One vial of 5 ml solution contains 3,750 Units.
* The active substance is a covalent conjugate of
_Escherichia coli_
-derived L-asparaginase with
monomethoxypolyethylene glycol
**One unit is defined as the quantity of enzyme required to liberate 1
µmol ammonia per minute at
pH 7.3 and 37°C
The potency of this medicinal product should not be compared to the
one of another pegylated or
non-pegylated protein of the same therapeutic class. For more
information, see section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oncaspar is indicated as a component of antineoplastic combination
therapy in acute lymphoblastic
leukaemia (ALL) in paediatric patients from birth to 18 years, and
adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oncaspar should be prescribed and administered by physicians and/or
health care personnel
experienced in the use of antineoplastic products. It should only be
given in a hospital setting where
appropriate resuscitation equipment is available. Patients should be
closely monitored and carefully
observed for any adverse reactions throughout the administration
period (see section 4.4).
Posology
Oncaspar is usually administered as part of combination chemotherapy
protocols with other
antineoplastic agents (see also section 4.5).
_Paediatric patients and adults ≤21 years _
The recommended dose in patients with a body surface area (BSA) ≥0.6
m
2
and who are ≤
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