GALAFOLD 123 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MIGALASTAT AS HYDROCHLORIDE

Fáanlegur frá:

TRUEMED LTD, ISRAEL

Lyfjaform:

HARD CAPSULE

Samsetning:

MIGALASTAT AS HYDROCHLORIDE 123 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

AMICUS THERAPEUTICS UK LTD, UK

Ábendingar:

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.

Leyfisdagur:

2022-05-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
GALAFOLD 123 MG
HARD CAPSULES
Each hard capsule contains the
ACTIVE INGREDIENT
:
Migalastat 123 mg (as migalastat hydrochloride 150 mg). The list of
inactive and allergenic ingredients is
detailed in section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist. This
medicine has been prescribed to treat your ailment. Do not pass it on
to others. It may harm them even if
it seems to you that their medical condition is similar.
The medicine is intended for adults and adolescents aged 16 years and
older with certain genetic changes
(mutations).
1. WHAT IS THE MEDICINE INTENDED FOR?
Galafold 123 mg is intended for the long-term treatment of adults and
adolescents aged 16 years and
older, with a confirmed diagnosis of Fabry disease (impaired
alpha-galactosidase A enzyme activity) and
who have “amenable mutations”.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient migalastat or to
any of the additional
ingredients contained in the medicine (see section 6 in the leaflet).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
BEFORE TREATMENT WITH GALAFOLD 123 MG, TELL YOUR DOCTOR
if you are currently taking enzyme
replacement therapy. Do not use Galafold 123 mg if you are currently
receiving enzyme replacement
therapy.
While you are being treated with Galafold 123 mg, every 6 months your
doctor will monitor your medical
condition and whether the medicine is working. If your condition
worsens, your doctor may perform an
additional evaluation or may stop your treatment with Galafold 123 mg.
Talk to your doctor before taking Galafold if you have severely
reduced kidney function as Galafold is
not recommended for use in patients with severe renal insufficiency
(

Vara einkenni

1
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 with an opaque blue cap and opaque white body printed
with “A1001”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galafold 123 mg 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 (see the table in section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Galafold 123mg should be initiated and supervised by
specialist physicians
experienced in the diagnosis and treatment of Fabry disease. Galafold
123mg is not intended for
concomitant use with enzyme replacement therapy (see section 4.4).
Posology
The recommended dosage regimen in adults and adolescents 16 years and
older is 123 mg migalastat
(1 capsule) once every other day at the same time of day.
_Missed dose _
_ _
Galafold 123mg 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 123mg 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 123mg
at the next planned dosing day and time according to the every other
day dosing schedule.
Special populations
_ _
_Elderly population _
_ _
No dosage adjustment is required based on age (see section 5.2).
_Renal impairment _
_ _
Galafold 123mg 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).
2
_Hepatic impairment _
_ _
No dosage adjustment of Galafold 123mg is required in patients with
hepatic impairment (see
section 5.2).
_Paediatric population _
_ _
The safety and efficacy of Galafold 123mg in children aged less than
16 years have