Vimizim
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-02-2019
Fachinformation
(SPC)
08-02-2019
Öffentlichen Beurteilungsberichts
(PAR)
26-06-2014
Wirkstoff:
recombinant human n-acetylgalactosamine-6-sulfatase
Verfügbar ab:
BioMarin International Limited
ATC-Code:
A16AB12
INN (Internationale Bezeichnung):
elosulfase alfa
Therapiegruppe:
Other alimentary tract and metabolism products,
Therapiebereich:
Mucopolysaccharidosis IV
Anwendungsgebiete:
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Produktbesonderheiten:
Revision: 13
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2014-04-27
Gebrauchsinformation
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIMIZIM 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
elosulfase 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 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.
-
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 Vimizim is and what it is used for
2.
What you need to know before you are given Vimizim
3.
How Vimizim is given
4.
Possible side effects
5.
How to store Vimizim
6.
Contents of the pack and other information
1.
WHAT VIMIZIM IS AND WHAT IT IS USED FOR
Vimizim contains an enzyme called elosulfase alfa, which belongs to a
group of medicines known as
enzyme replacement therapies. It is used to treat adults and children
with mucopolysaccharidosis
type IVA (MPS IVA disease, also known as Morquio A Syndrome).
People with MPS IVA disease either lack completely or do not have
enough N-acetylgalactosamine-6-
sulfatase, an enzyme which breaks down specific substances in the body
such as keratan sulphate,
which are found in many tissues of the body, including cartilage and
bone. As a result, these
substances do not get broken down and processed by the body as they
should. They accumulate in the
tissues interfering with their normal function and causing the
symptoms of MPS IVA, such as
difficulty walking, trouble breathing, short height, and hearing loss.
HOW VIMIZIM WORKS
This medicine replaces the natural enzyme
N-acetylgalactosamine-6-sulfatase which is lacking in
MPS IVA patients. Treatment has been shown to improve walking and to
reduce the levels of keratan
sulphate in t
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Fachinformation
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
Vimizim 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml
contains 5 mg elosulfase alfa.
*Elosulfase alfa is a recombinant form of human
N-acetylgalactosamine-6-sulfatase (rhGALNS) and
is produced in Chinese Hamster Ovary cell culture by recombinant DNA
technology.
Excipients with known effect:
Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (Sterile concentrate).
A clear to slightly opalescent and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimizim is indicated for the treatment of mucopolysaccharidosis, type
IVA (Morquio A Syndrome,
MPS IVA) in patients of all ages.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be supervised by a physician experienced in the
management of patients with
MPS IVA or other inherited metabolic diseases. Administration of
Vimizim should be carried out by
an appropriately trained healthcare professional with the ability to
manage medical emergencies.
Home administration under the supervision of an appropriately trained
healthcare professional may be
considered for patients who are tolerating their infusions well.
_ _
Posology
The recommended dose of elosulfase alfa is 2 mg/kg of body weight
administered once a week. The
total volume of the infusion should be delivered over approximately 4
hours (see Table 1).
Because of the potential for hypersensitivity reactions with
elosulfase alfa, patients should receive
antihistamines with or without antipyretics 30 to 60 min
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