Galafold
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
25-05-2023
Svojstava lijeka
(SPC)
25-05-2023
Izvješće o ocjeni javnog
(PAR)
27-08-2021
Aktivni sastojci:
Migalastat hydrochloride
Dostupno od:
Amicus Therapeutics Europe Limited
ATC koda:
A16AX
INN (International ime):
migalastat
Terapijska grupa:
migalastat
Područje terapije:
Fabry Disease
Terapijske indikacije:
Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.
Proizvod sažetak:
Revision: 16
Status autorizacije:
Authorised
Datum autorizacije:
2016-05-25
Uputa o lijeku
50
B.
PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GALAFOLD 123 MG HARD CAPSULES
migalastat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Galafold is and what it is used for
2.
What you need to know before you take Galafold
3.
How to take Galafold
4.
Possible side effects
5.
How to store Galafold
6.
Contents of the pack and other information
1.
WHAT GALAFOLD IS AND WHAT IT IS USED FOR
Galafold
contains the active substance migalastat.
This medicine is used for the long-term treatment of Fabry disease in
adults
and adolescents aged
12 years and older who have certain genetic mutations (changes).
Fabry disease is caused by the lack of or a faulty enzyme called
alpha-galactosidase A (α-Gal A).
Depending upon the kind of mutation (change) in the gene that produces
α-Gal A, the enzyme does
not work properly or is completely absent. This enzyme defect leads to
abnormal deposits of a fatty
substance known as globotriaosylceramide (GL-3) in kidneys, heart, and
other organs, leading to the
symptoms of Fabry disease.
This medicine works by stabilising the enzyme that your body produces
naturally, so that it can work
better to reduce the amount of GL-3 that has accumulated in your cells
and tissues.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALAFOLD
DO NOT TAKE GALAFOLD IF YOU:
•
are allergic to migalastat or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
123 mg migalastat capsules are not for children (≥12 years) weig
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Galafold 123 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains migalastat hydrochloride equivalent to 123 mg
migalastat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque
white body with “A1001”
printed in black, containing white to pale brown powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galafold is indicated for long-term treatment of adults and
adolescents aged 12 years and older with a
confirmed diagnosis of Fabry disease (α-galactosidase A deficiency)
and who have an amenable
mutation (see the tables in section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Galafold should be initiated and supervised by
specialist physicians experienced in the
diagnosis and treatment of Fabry disease. Galafold is not intended for
concomitant use with enzyme
replacement therapy (see section 4.4).
Posology
The recommended dosage regimen is 123 mg migalastat (1 capsule) taken
once every other day at the
same time of the day.
_ _
_Missed dose _
Galafold should not be taken on 2 consecutive days. If a dose is
missed entirely for the day, the patient
should take the missed dose of Galafold only if it is within 12 hours
of the normal time the dose is
taken. If more than 12 hours has passed the patient should resume
taking Galafold at the next planned
dosing day and time according to the every other day dosing schedule.
3
Special populations
_ _
_Elderly population _
No dosage adjustment is required based on age (see section 5.2).
_ _
_ _
_Renal impairment _
Galafold is not recommended for use in patients with Fabry disease who
have estimated GFR less than
30 mL/min/1.73 m
2
(see section 5.2).
_ _
_Hepatic impairment_
No dosage adjustment of Galafold is required in patients with hepatic
impairment (see section 5.2).
_Paediatric population _
_Adolescents aged ≥ 12 to < 18 years and
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