Naglazyme
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-04-2022
Charakterystyka produktu
(SPC)
26-04-2022
Sprawozdanie z oceny publicznego
(PAR)
01-04-2011
Składnik aktywny:
galsulfase
Dostępny od:
BioMarin International Limited
Kod ATC:
A16AB
INN (International Nazwa):
galsulfase
Grupa terapeutyczna:
Other alimentary tract and metabolism products,
Dziedzina terapeutyczna:
Mucopolysaccharidosis VI
Wskazania:
Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Authorised
Data autoryzacji:
2006-01-23
Ulotka dla pacjenta
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAGLAZYME 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Galsulfase
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
WHAT IS IN THIS LEAFLET
:
1.
What this medicine is and what it is used for
2.
What you need to know before you are given this medicine
3.
How this medicine is given
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Naglazyme is used to treat patients with MPS VI disease
(Mucopolysaccharidosis VI).
People with MPS VI disease have either a low level, or no level, of an
enzyme called
N-acetylgalactosamine 4-sulfatase, which breaks down specific
substances (glycosaminoglycans) in
the body. As a result, these substances do not get broken down and
processed by the body as they
should. They accumulate in many tissues in the body, which causes the
symptoms of MPS VI.
HOW THIS MEDICINE WORKS
This medicine contains a recombinant enzyme called galsulfase. This
can replace the natural enzyme
which is lacking in MPS VI patients. Treatment has been shown to
improve walking and stair-
climbing ability, and to reduce the levels of glycosaminoglycans in
the body. This medicine may
improve the symptoms of MPS VI.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN THIS MEDICINE
YOU MUST NOT RECEIVE THIS MEDICINE
-
If you have experienced severe or life-threatening allergic
(hypersensitive) reactions to
galsulfase or any of the other ingredients of Naglazyme and
re-administration of the medicine
was not successful.
WARNINGS AND PRECAUTIONS
-
If you are treated with Naglazyme, you may develop infusion-associated
reactions. An infusion
associated reaction is
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Naglazyme 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg galsulfase. One vial of 5 ml
contains 5 mg galsulfase.
Galsulfase is a recombinant form of human N-acetylgalactosamine
4-sulfatase and is produced by
recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO)
cell culture.
_Excipients _
Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear to slightly opalescent, and colourless to pale yellow
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naglazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine
4-sulfatase deficiency;
Maroteaux-Lamy syndrome) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
As for all lysosomal genetic disorders, it is of primary importance,
especially in severe forms, to
initiate treatment as early as possible, before appearance of
non-reversible clinical manifestations of
the disease.
Naglazyme treatment should be supervised by a physician experienced in
the management of patients
with MPS VI or other inherited metabolic diseases. Administration of
Naglazyme should be carried
out in an appropriate clinical setting where resuscitation equipment
to manage medical emergencies
would be readily available
_. _
_ _
Posology
The recommended dose regimen for galsulfase is 1 mg/kg body weight
administered once every week
as an intravenous infusion over 4 hours.
_Special populations _
_ _
_Elderly _
The safety and efficacy of Naglazyme in patients older than 65 years
has not been established, and no
alternative dose regimen can be recommended in these patients.
_Renal and hepatic impairment _
3
The safety and efficacy of Naglazyme in patients with renal or hepatic
insufficiency have n
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