MIGLUSTAT G.L. 100 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

MIGLUSTAT

Dostupné s:

A.L. MEDI-MARKET LTD.

ATC kód:

A16AX06

Léková forma:

CAPSULES

Složení:

MIGLUSTAT 100 MG

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

G.L. PHARMA GMBH, AUSTRIA

Terapeutické oblasti:

MIGLUSTAT

Terapeutické indikace:

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

Datum autorizace:

2023-06-14

Informace pro uživatele

Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations)
- 1986
This medicine is dispensed with a doctor's prescription only
Miglustat G.L. 100 mg
Capsules
Active ingredient and quantity
Each capsule contains: miglustat 100 mg
For a list of the inactive ingredients in this medicine: see section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start 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.
This medicine is not intended for children and adolescents under the
age of 18
years with type 1 Gaucher disease.
1.
What is this medicine intended for?
•
Treatment of mild to moderate type 1 Gaucher disease in patients who
have
been found unsuitable for enzyme replacement therapy.
•
Treatment of progressive neurological symptoms in adults and children
who
suffer from Niemann-Pick type C disease.
Therapeutic group: An enzyme inhibitor that affects 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 (see section 6 – ‘Additional
information’).
•
You are pregnant or breastfeeding.
Special warnings about using this medicine
•
Before using Miglustat G.L. 100 mg, tell your doctor if:
-
You suffer from kidney disease.
-
You suffer from liver disease.
-
You are sensitive to any food or medicine.
•
If you suffer from diarrhea, your doctor may recommend a change in
your diet to
lower the amount of lactose and carbohydrates consumed (such as
sucrose), or
not to take Miglustat G.L. 100 mg together with food, or to
temporarily reduce
your dose. In some cases,