Krystexxa
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-07-2016
Charakterystyka produktu
(SPC)
22-07-2016
Sprawozdanie z oceny publicznego
(PAR)
22-07-2016
Składnik aktywny:
pegloticase
Dostępny od:
Crealta Pharmaceuticals Ireland Limited
Kod ATC:
M04AX02
INN (International Nazwa):
pegloticase
Grupa terapeutyczna:
Antigout preparations
Dziedzina terapeutyczna:
Gout
Wskazania:
Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
Podsumowanie produktu:
Revision: 3
Status autoryzacji:
Withdrawn
Data autoryzacji:
2013-01-08
Ulotka dla pacjenta
20
B. PACKAGE LEAFLET
Medicinal product no longer authorised
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
KRYSTEXXA 8 MG CONCENTRATE FOR SOLUTION FOR INFUSION
pegloticase
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.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What KRYSTEXXA is and what it is used for
2.
What you need to know before you receive KRYSTEXXA
3.
How to use KRYSTEXXA
4.
Possible side effects
5.
How to store KRYSTEXXA
6.
Contents of the pack and other information
1.
WHAT KRYSTEXXA IS AND WHAT IT IS USED FOR
KRYSTEXXA contains the active substance pegloticase. Pegloticase
belongs to the class anti-gout
medicines.
Pegloticase is used to treat severe long-term gout in adult patients
who also have one or more painful
deposits of uric acid crystals under the skin that cause difficulty in
carrying out daily activities and
who do not respond or cannot take other anti-gout medicines.
HOW KRYSTEXXA WORKS
People with gout have too much uric acid in their body. Uric acid
deposits as crystals in joints,
kidneys, and other organs which may cause profound pain, redness and
swelling (inflammation).
KRYSTEXXA contains an enzyme called uricase that transforms the uric
acid into a substance called
allantoin, which can be removed easily in the urine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE KRYSTEXXA
DO NOT USE KRYSTEXXA
•
If you are allergic to pegloticase, or other uricases or any of the
other ingredients of this
medicine (listed in section 6).
•
If you have a rare blood problem called glucose 6-phosphate
dehydrogenase (G6PD) deficiency
or favism. Your doctor may test you for G6PD before you start
KRYSTEXXA.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE USING KRYSTEXXA:
-
IF Y
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
KRYSTEXXA 8 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 8 mg of pegloticase (8 mg/ml concentrate). The
strength indicates the quantity of
the uricase moiety of pegloticase without consideration of the
PEGylation.
The active substance pegloticase is a covalent conjugate of uricase
produced by a genetically modified
strain of Escherichia coli and monomethoxypoly (ethylene glycol).
The potency of this product should not be compared to the one of
another pegylated or non-pegylated
protein of the same therapeutic class.
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KRYSTEXXA is indicated for the treatment of severe debilitating
chronic tophaceous gout in adult
patients who may also have erosive joint involvement and who have
failed to normalize serum uric
acid with xanthine oxidase inhibitors at the maximum medically
appropriate dose or for whom these
medicines are contraindicated (see section 4.4).
The decision to treat with KRYSTEXXA should be based on an on-going
assessment of the benefits
and risks for the individual patient (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialist physicians
experienced in the diagnosis and
treatment of severe refractory chronic gout.
The medicinal product should be administered in a healthcare setting
and by healthcare professionals
prepared to manage anaphylaxis and infusion reactions. Close
monitoring is required during the
infusion and for at least 2 hours after the end of the infusion.
Availability of resuscitation equipment
must be ensured. Delayed-type hypersensitivity reactions have also
been reported.
Posology
The recommended dose is 8 mg pegloticase given
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