ZAVESCA

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

MIGLUSTAT

Dostupné z:

J-C HEALTH CARE LTD

ATC kód:

A16AX06

Forma lieku:

CAPSULES

Zloženie:

MIGLUSTAT 100 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ACTELION PHARMACEUTICALS LTD., SWITZERLAND

Terapeutické skupiny:

MIGLUSTAT

Terapeutické oblasti:

MIGLUSTAT

Terapeutické indikácie:

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

Dátum Autorizácia:

2023-05-31

Príbalový leták

ىلإ
ً
لااح هجوت ،ءاودلا نم أطخلاب لفط علب
اذإ وأ
ً
اطرفم
ً
ارادقم أطخلاب تلوانت اذإ
.ءاودلا ةبلع كعم رضحأو ،ىفشتسملا يف
ئراوطلا ةفرغ ىلإ وأ بيبطلا
دهوش ،غلم 3000 ىتح ةيئاود ريداقمبو
ةيريرسلا ثاحبلأا يف اكسيڤاز لامعتسإ
للاخ
ةرقفلا يف ةروكذملا كلت هبشت ةيفاضإ
ةيبناج ضارعأو ءاضيبلا مدلا تايرك يف
ضافخنإ
.ةرشنلا هذه نم 4
تقولا يف يلاتلا يئاودلا رادقملا لوانت
،بولطملا تقولا يف ءاودلا اذه لوانت
تيسن اذإ
.يسنملا رادقملا نع ضيوعتلل
ً
افعاضم
ً
ارادقم لوانت زوجي لا .بيبطلا رشتساو
يدايتعلإا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
ءاودلا لوانت نع تفقوت اذإ
.بيبطلا ةراشتسإ نود نم جلاعلا نع
فقوتلا زوجي لا رادقملا نم دكأتلاو ءاودلا عباط صيخشت
بجي !ةمتعلا يف ةيودأ لوانت زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت ةرم لك يف يئاودلا
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا اذه
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
ةيبناجلا ضارعلأا )4
.نيلمعتسملا ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق اكسيڤاز لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا
:ةيلاتلا ةيبناجلا ضارعلأا ىدحإ ترهظ
اذإ يروف لكشب بيبطلا ىلإ ه
ّ
جوت
:ةروطخ رثكلأا ةيبناجلا ضارعلأا
●
تدهوش( نيمدقلا يتحارو نيديلا يف
ليمنتلاب وأ زخ

Súhrn charakteristických

1
Zavesca PI_Oct-2021
ZAVESCA®
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Zavesca®
Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg miglustat.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard
White capsules with “OGT 918” printed in black on the cap and
“100” printed in black on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zavesca is indicated for the oral treatment of mild to moderate type 1
Gaucher disease. Zavesca may
be used only in the treatment of patients for whom enzyme replacement
therapy is unsuitable (see
sections 4.4 and 5.1).
Zavesca is indicated for the treatment of progressive neurological
manifestations in adult patients
and paediatric patients with Niemann-Pick type C disease (see sections
4.4, and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be directed by physicians who are knowledgeable in the
management of Gaucher
disease or Niemann-Pick type C disease, as appropriate.
Posology
_Dosage in type 1 Gaucher disease _
Adults
The recommended starting dose for the treatment of patients with type
1 Gaucher disease is
100 mg three times a day.
Temporary dose reduction to 100 mg once or twice a day may be
necessary in some patients
because of diarrhoea.
Paediatric population
The efficacy of Zavesca in children and adolescents aged 0-17 years
with type 1 Gaucher disease has
not been established. No data are available.
_Dosage in Niemann-Pick type C disease _
Adult
The recommended dose for the treatment of adult patients with
Niemann-Pick type C disease is
200 mg three times a day.
Paediatric population
The recommended dose for the treatment of adolescent patients (12
years of age and above) with
Niemann-Pick type C disease is 200 mg three times a day.
2
Zavesca PI_Oct-2021
Dosing in patients under the age of 12 years should be adjusted on the
basis of body surface area as
illustrated below:
Body surface area (m
2
)
Recommended dose
>
1.25
200mg three times a day
>
0.88 - 1.25