Brineura
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
12-12-2023
Данни за продукта
(SPC)
12-12-2023
Доклад обществена оценка
(PAR)
22-06-2017
Активна съставка:
cerliponase alfa
Предлага се от:
BioMarin International Limited
АТС код:
A16AB
INN (Международно Name):
cerliponase alfa
Терапевтична група:
Other alimentary tract and metabolism products,
Терапевтична област:
Neuronal Ceroid-Lipofuscinoses
Терапевтични показания:
Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency,
Каталог на резюме:
Revision: 6
Статус Оторизация:
Authorised
Дата Оторизация:
2017-05-30
Листовка
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRINEURA 150 MG SOLUTION FOR INFUSION
cerliponase alfa
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 OR YOUR CHILD IS 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 or your child 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 Brineura is and what it is used for
2.
What you need to know before you or your child is given Brineura
3.
How Brineura is given
4.
Possible side effects
5.
How to store Brineura
6.
Contents of the pack and other information
1.
WHAT BRINEURA IS AND WHAT IT IS USED FOR
Brineura contains the active substance cerliponase alfa, which belongs
to a group of medicines known
as enzyme replacement therapies. It is used to treat patients with
neuronal ceroid lipofuscinosis type 2
(CLN2) disease, also known as tripeptidyl peptidase-1 (TPP1)
deficiency.
People with CLN2 disease do not have any enzyme called TPP1 or they
have too little of it and this
causes a build-up of substances called lysosomal storage materials. In
people with CLN2 disease,
these materials build-up in certain parts of the body, mainly the
brain.
HOW BRINEURA WORKS
This medicine replaces the missing enzyme, TPP1, which minimises the
build-up of the lysosomal
storage materials. This medicine works to slow the progression of the
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD IS GIVEN BRINEURA
YOU MUST NOT RECEIVE BRINEURA
-
If you or your child has had life-threatening allergic reactions to
cerliponase alfa or any of the
other ingredients of this medicine (listed in section 6), and the
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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
Brineura 150 mg solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of
solution.
Each ml of solution for infusion contains 30 mg of cerliponase alfa.
*Produced in mammalian Chinese Hamster Ovary cells.
Excipient with known effect:
Each vial contains 17.4 mg of sodium in 5 ml of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear to slightly opalescent and colourless to pale yellow solution,
that may occasionally contain thin
translucent fibres or opaque particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brineura is indicated for the treatment of neuronal ceroid
lipofuscinosis type 2 (CLN2) disease, also
known as tripeptidyl peptidase 1 (TPP1) deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Brineura must only be administered by a trained healthcare
professional knowledgeable in
intracerebroventricular administration in a healthcare setting.
Posology
The recommended dose is 300 mg cerliponase alfa administered once
every other week by
intracerebroventricular infusion.
In patients less than 2 years of age, lower doses are recommended, see
paediatric population section.
Pre-treatment of patients with antihistamines with or without
antipyretics is recommended 30 to
60 minutes prior to the start of infusion.
Continuation of long-term treatment should be subject to regular
clinical evaluation whether the
benefits are considered to outweigh the potential risks to individual
patients.
3
_ _
_Dose adjustments _
Consideration of dose adjustments may be necessary for patients who
may not tolerate the infusion.
The dose may be reduced by 50%
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