GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

migalastat hydrochloride, Quantity: 150 mg

থেকে পাওয়া:

Amicus Therapeutics Pty Ltd

INN (আন্তর্জাতিক নাম):

migalastat hydrochloride

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

রচনা:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; indigo carmine; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; Gelatin; sodium lauryl sulfate

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

14 capsules

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Galafold is indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation (see the table in Section 5.1 Pharmacodynamic properties, Mechanism of action).

পণ্য সারাংশ:

Visual Identification: Size 2 hard capsule with an opaque blue cap and opaque white body with A1001 printed in black; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

2017-08-11

তথ্য লিফলেট

Galafold® migalastat 123 mg Hard Capsule
GALAFOLD® MIGALASTAT 123 MG HARD CAPSULES
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak
to your doctor or pharmacist.
1.
WHY AM I USING GALAFOLD?
Galafold contains the active ingredient migalastat. Galafold is used
for the long-term treatment of Fabry disease in adults and
adolescents aged 16 years and older who have certain genetic mutations
(amenable mutations).
For more information, see Section 1. Why am I using Galafold? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GALAFOLD?
Do not use if you have ever had an allergic reaction to Galafold or
any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Galafold? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Galafold and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE GALAFOLD?
Take one capsule every other day at the same time of the day. Swallow
the capsule whole.
Take the GALAFOLD capsule on an empty stomach. Do not eat food at
least 2 hours before and 2 hours after taking your
medicine after taking Galafold to give a minimum 4 hours fast.
More instructions can be found in Section 4. How do I use Galafold? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GALAFOLD?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using Galafold.
•
Tell your doctor if you have any kidney problems.
•
Use effective birth control while taking Galafold.
THINGS YOU SHOULD NOT DO
•
Do not take Galafold if you are also receiving enzyme replacement
therapy.
•
Do not take Galafold if you are allergic to migalastat or any of the
other ingredients i

পণ্য বৈশিষ্ট্য

Galafold Product Information
Page 1
AUSTRALIAN PI
– GALAFOLD
® (MIGALASTAT) HARD CAPSULES
1
NAME OF THE MEDICINE
Migalastat
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION
AND PHARMACEUTICAL FORM
Galafold capsule contains 123 mg migalastat equivalent to 150 mg
migalastat
hydrochloride.
Galafold capsule is a size 2 hard capsule (6.4 x 18.0 mm) with an
opaque blue cap and
opaque white body with “A1001” printed in black.
For the full list of excipients, see Section 6.1 List of excipients.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galafold is indicated for long-term treatment of adult and adolescent
patients 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
Pharmacodynamic
properties, Mechanism of action).
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE (DOSE AND INTERVAL) _
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 ERT.
The recommended dosage regimen in adults and adolescents 16 years and
older is
123 mg migalastat (1 capsule) orally once every other day at the same
time of day.
Galafold should not be taken on 2 consecutive days. Capsules must be
swallowed whole.
The capsules must not be cut, crushed, or chewed.
Missed dose
If the usual dosing time is missed, 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.
_DOSAGE ADJUSTMENT _
Paediatric population
The safety and efficacy of Galafold in children aged 0 to 15 years has
not yet been
established. No data are available.
Use in the elderly
No dosage adjustment is required based on age.
Galafold Product Information
Page 2
Use in renal impairment
Galafold is not recom