BRAZAVES CAPSULES 100mg (ブレーザベスカプセル100mg)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Miglustat

Available from:

JANSSEN PHARMACEUTICAL K.K.

INN (International Name):

Miglustat

Pharmaceutical form:

white capsules, major axis: 14 mm, minor axis: 6.5 mm

Product summary:

Print on wrapping: (back) ブレーザベス カプセル 100mg, BRAZAVES capsules 100mg

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 03/2021
The information on this sheet is based on approvals granted by the
Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks)
as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To
obtain a better therapeutic response,
patients should understand their medication and cooperate with the
treatment.
BRAND NAME:
BRAZAVES CAPSULES 100MG
ACTIVE INGREDIENT:
Miglustat
DOSAGE FORM:
white capsules, major axis: 14 mm, minor axis: 6.5 mm
IMPRINT OR PRINT ON WRAPPING:
(back) ブレーザベス カプセル 100mg,
BRAZAVES capsules 100mg
EFFECTS OF THIS MEDICINE
This medicine blocks glucosylceramide synthesis and suppresses
excessive accumulation of
lipid in the brain. It consequently improves disorders of eye
movement, food swallowing,
walking and mental ability.
It is usually used to treat Niemann-Pick disease type C.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN USING THIS
MEDICINE.BE SURE TO TELL YOUR DOCTOR
AND PHARMACIST.
・If you have previously experienced any allergic reactions (itch,
rash, etc.) to any medicines
or foods.
If you have gastrointestinal disorder, renal disorder or liver
disorder.
・If you are pregnant, possibly pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may
interact to enhance or
diminish medicinal effects. Beware of over-the-counter medicines and
dietary supplements
as well as other prescription medicines.)
DOSING SCHEDULE (HOW TO TAKE THIS MEDICINE)
・
Your dosing schedule prescribed by your doctor is((         

to be written by a healthcare
professional
))
・In general, for adults, take 2 capsules (200 mg of the active
ingredient) at a time, 3 times a
day. For children, for patients with under 0.47 m
2
of BSA (body surface area), take 1 capsule
at a time, once a day, for patients with over 0.47 m
2
to 0.73 m
2
of BSA, take 1 capsule at a
tim