VOTUBIA 2 MG

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

EVEROLIMUS

Fáanlegur frá:

NOVARTIS ISRAEL LTD

ATC númer:

L04AA18

Lyfjaform:

TABLETS DISPERSIBLE

Samsetning:

EVEROLIMUS 2 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Lækningarsvæði:

EVEROLIMUS

Ábendingar:

Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory epileptic seizures are associated with tuberous sclerosis complex (TSC).

Leyfisdagur:

2020-06-07

Upplýsingar fylgiseðill

.6
ةيفاضإ تامولعم
:ىلع
ً
اضيأ ءاودلا يوتحي ةلا
ّ
عفلا ةداملا ىلإ ةفاضلإاب
Mannitol, cellulose microcrystalline, crospovidone, hypromellose,
magnesium
stearate,
silica
colloidal
anhydrous,
lactose
monohydrate
and
butylated
hydroxytoluene.
.تارديهونوم زوتكلا غلم 1.96 ىلع يوتحي
غلم 2 ايبوتوڤ صرق لك
.تارديهونوم زوتكلا غلم 2.94 ىلع يوتحي
غلم 3 ايبوتوڤ صرق لك
:ة
ّ
وبعلا يوحت اذامو ءاودلا ودبي فيك
ةحطسم ،ةريدتسم ،
ً
لايلق رفصلأل لئام نول ىتح نوللا ءاضيب
نابوذلل ةلباقلا صارقلأا نوكت
.رطشلل طخ نودبو ةلئام فاوح تاذ
دحاو بناج ىلع "D2" متخ عم اهيلع روفحم
نابوذلل ةلباقلا صارقلأا :غلم 2 ايبوتوڤ
.رخلآا بناجلا ىلع "NVR" -و
دحاو بناج ىلع "D3" متخ عم اهيلع روفحم
نابوذلل ةلباقلا صارقلأا :غلم 3 ايبوتوڤ
.رخلآا بناجلا ىلع "NVR" -و
.ةطرشأ يف ةدوجوم نابوذلل لاباق ا
ً
صرق 30 ىلع يوتحت غلم 2 ايبوتوڤ نم ةوبع لك
.ةطرشأ يف ةدوجوم نابوذلل لاباق ا
ً
صرق 30 ىلع يوتحت غلم 3 ايبوتوڤ ة
ّ
وبع لك
.تا
ّ
وبعلا ماجحأ عيمج قيوست
ّ
متي لا دق
:دروتسملاو ليجستلا بحاص
.بيبأ لت ،7126 .ب.ص ،.ض.م ليئارسإ سيترڤون
.ةحصلا ةرازو تاميلعت قفو 2021 بآ يف
اهريرحت مت
:ة
ّ
حصلا ةرازو يف
ّ
يمسرلا ةيودلأا
ّ
لجس يف ءاودلا ليجست مقر
164-73-35765
غلم 2 ايبوتوڤ
164-74-35766
غلم 3 ايبوتوڤ
لاكل
ّ
دعم ءاودلاف اذه عم .ر
ّ
كذملا ةغيصب
ّ
صنلا درو اهليهستو ةرشنلا هذه ةءارق
طيسبتل
.نيسنجلا
لامعتسلاا تاميلعت ود

Vara einkenni

VOTU API SEP22 V3
1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Votubia 2 mg
Votubia 3 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Votubia 2 mg dispersible tablets
Each dispersible tablet contains 2 mg everolimus.
_Excipient with known effect _
Each dispersible tablet contains 1.96 mg lactose monohydrate.
Votubia 3 mg dispersible tablets
Each dispersible tablet contains 3 mg everolimus.
_Excipient with known effect _
Each dispersible tablet contains 2.94 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablet.
Votubia 2 mg dispersible tablets
White to slightly yellowish, round, flat, with beveled edges, unscored
tablet, with
smooth surface, debossed with “D2” on one side and “NVR” on
the other side
Votubia 3 mg dispersible tablets
White to slightly yellowish, round, flat, with beveled edges, unscored
tablet, with
smooth surface, debossed with“D3” on one side and “NVR” on the
other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Votubia is indicated as adjunctive treatment of patients aged 2 years
and older
whose refractory epileptic seizures are associated with tuberous
sclerosis complex
(TSC)
VOTU API SEP22 V3
2 4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage/Administration
Treatment
with
Votubia
should
be
initiated
by
a
physician
experienced
in
therapeutic drug monitoring and the treatment of patients with
tuberous sclerosis
complex (TSC).
Votubia should be taken orally once daily at the same time every day,
either
consistently with or consistently without food.
The patient should not make up for a missed dose, but should take the
next
prescribed dose as usual.
Treatment
should
continue
as
long
as
a
clinical
benefit
is
observed
or
until
unacceptable toxicity occurs.Votubia dispersible tablets are
recommended only for
the treatment of TSC patients with refractory epileptic seizures who
are undergoing
therapeutic drug monitoring.
Votubia dispersible tablets disintegrate quickly in water, forming a
suspension that