Elaprase
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-12-2022
Charakterystyka produktu
(SPC)
15-12-2022
Sprawozdanie z oceny publicznego
(PAR)
26-10-2016
Składnik aktywny:
idursulfase
Dostępny od:
Takeda Pharmaceuticals International AG Ireland Branch
Kod ATC:
A16AB09
INN (International Nazwa):
idursulfase
Grupa terapeutyczna:
Other alimentary tract and metabolism products,
Dziedzina terapeutyczna:
Mucopolysaccharidosis II
Wskazania:
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Podsumowanie produktu:
Revision: 25
Status autoryzacji:
Authorised
Data autoryzacji:
2007-01-08
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELAPRASE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
idursulfase
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Elaprase is and what it is used for
2.
What you need to know before you use Elaprase
3.
How to use Elaprase
4.
Possible side effects
5.
How to store Elaprase
6.
Contents of the pack and other information
1.
WHAT ELAPRASE IS AND WHAT IT IS USED FOR
Elaprase is used as enzyme replacement therapy to treat children and
adults with Hunter syndrome
(Mucopolysaccharidosis II) when the level of the enzyme
iduronate-2-sulfatase in the body is lower
than normal, helping improve the symptoms of the disease. If you
suffer from Hunter syndrome, a
carbohydrate called glycosaminoglycan which is normally broken down by
your body, is not broken
down and slowly accumulates in various organs in your body. This
causes cells to function
abnormally, thereby causing problems for various organs in your body
which can lead to tissue
destruction and organ malfunction and failure. Typical organs where
glycosaminoglycan accumulates
are spleen, liver, lungs, heart, and connective tissue. In some
patients glycosaminoglycan accumulates
also in the brain. Elaprase contains an active substance called
idursulfase
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Charakterystyka produktu
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
Elaprase 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of
idursulfase*.
Excipient with known effect
Each vial contains 0.482 mmol of sodium.
For the full list of excipients, see section 6.1.
* idursulfase is produced by recombinant DNA technology in a
continuous human cell line.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear to slightly opalescent, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Elaprase is indicated for the long-term treatment of patients with
Hunter syndrome
(Mucopolysaccharidosis II, MPS II).
Heterozygous females were not studied in the clinical trials.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This treatment should be supervised by a physician or other healthcare
professional experienced in the
management of patients with MPS II disease or other inherited
metabolic disorders.
Posology
Elaprase is administered at a dose of 0.5 mg/kg body weight every week
by intravenous infusion over
a 3 hour period, which may be gradually reduced to 1 hour if no
infusion-associated reactions are
observed (see section 4.4).
For instructions for use, see section 6.6.
Infusion at home may be considered for patients who have received
several months of treatment in the
clinic and who are tolerating their infusions well. Home infusions
should be performed under the
surveillance of a physician or other healthcare professional.
Special populations
_Elderly patients_
There is no clinical experience in patients over 65 years of age.
3
_Patients with renal or hepatic impairment_
There is no clinical experience in patie
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