MIGLUSTAT DIPHARMA

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

MIGLUSTAT

から入手可能:

MBI PHARMA LTD., ISRAEL

ATCコード:

A16AX06

医薬品形態:

HARD CAPSULE

構図:

MIGLUSTAT 100 MG

投与経路:

PER OS

処方タイプ:

Required

製:

DOPPEL FARMACEUTICI S.R.L., ITALY

治療領域:

MIGLUSTAT

適応症:

Miglustat Dipharma is indicated for the oral treatment of mild to moderate type I Gaucher disease. Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

承認日:

2020-10-14

情報リーフレット

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MIGLUSTAT DIPHARMA
HARD CAPSULES
NAME AND QUANTITY OF ACTIVE INGREDIENT:
Each capsule contains:
miglustat 100 mg
For list of inactive ingredients in this medicine see section 6
"Additional Information". READ THIS
ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet
contains concise information about
this medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
•
Treatment of mild to moderate type 1 Gaucher disease, in patients who
are considered
unsuitable for treatment with enzyme replacement therapy.
•
Treatment of progressive neurological symptoms in adults and children
who have Niemann-
Pick type C disease.
THERAPEUTIC GROUP: enzyme inhibitor, affects the metabolism.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (miglustat) or
to any of the other
ingredients in this medicine.
•
You are pregnant or breastfeeding.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
BEFORE TREATMENT WITH MIGLUSTAT DIPHARMA TELL YOUR DOCTOR IF:
−
You suffer from kidney disease.
−
You suffer from liver disease.
•
If you have diarrhea, your doctor may recommend a change in your diet
in order to reduce
the amount of lactose and carbohydrates intake (such as sucrose), or
that you not take
Miglustat Dipharma together with food, or temporarily reduce your
dosage.
In certain cases, your doctor may consider prescribing an
anti-diarrheal medicine such as
loperamide. If your diarrhea is not relieved by these measures or if
you have some other
gastrointestinal problem, consult your doctor. If this happens, your
doctor may decide to
conduct a further inquiry.
•
Male pa