ENTECAVIR TEVA 0.5 MG

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

ENTECAVIR AS MONOHYDRATE

Dostępny od:

TEVA ISRAEL LTD

Kod ATC:

J05AF10

Forma farmaceutyczna:

FILM COATED TABLETS

Skład:

ENTECAVIR AS MONOHYDRATE 0.5 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Dziedzina terapeutyczna:

ENTECAVIR

Wskazania:

Entecavir teva is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: - Compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (ALT) levels. - Decompensated liver disease.

Data autoryzacji:

2020-10-31

Ulotka dla pacjenta

•
كيلع فيك يلديصلا لأسا .ةمامقلا ةيواح
يف وأ يحصلا فرصلا هايم يف ةيودلأا
ءاقلإ عنم
ُ
ي
.ةئيبلا ةيامح يف ريبادتلا هذه دعاست
.ةلمعتسملا ريغ ةيودلأا نم صلختلا
6 .
ة
ّ
يفاضإ تامولعم
:ىلع ا
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ضيأ ءاودلا يوتحي ،لا
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ّ
كرملا ىلإ ةفاضإ
:غلم 0.5 عڨيت ريڨاكيتنإ
Mannitol, Cellulose, microcrystalline )Avicel PH 101(, Maize Starch-Rx
1500 Pregelatinized, Crospovidone Type A, Magnesium Stearate,
Poly (vinyl alcohol) partially hydrolysed (E1203), Titanium Dioxide
(E171), Macrogol (polyethylene glycol) MW3350, Talc (E553b).
:غلم 1 عڨيت ريڨاكيتنإ
Mannitol, Cellulose, microcrystalline (Avicel PH 101), Maize Starch-Rx
1500 Pregelatinized, Crospovidone Type A, Magnesium Stearate,
Poly (vinyl alcohol) partially hydrolyzed (E1203), Titanium Dioxide
(E171), Macrogol (polyethylene glycol) MW3350, Talc (E553b), Iron
oxide red (E172).
:ةوبعلا يوحت اذامو ءاودلا ودبي فيك
:غلم 0.5 عڨيت ريڨاكيتنإ
يفو "05" هيلع شوقنم دحاو بناج يف ، )Off-white)
يميرك ىتح ضيبأ هنول ريدتسم صرق
. E" شقنلا هيلع رخلآا بناجلا
:غلم 1 عڨيت ريڨاكيتنإ
"1" هيلع شوقنم دحاو بناج يف ،رطشلل قيمع
طخ عم ،يدرو ىتح حتاف يدرو هنول ريدتسم
صرق
."E/E" شقنلا هيلع رخلآا بناجلا يفو
.ةبوطرلل صامو ايلطم اصرق 30 ىلع ةنينقلا
يوتحت
.ايلطم اصرق 30 وأ 10 ،7 ىلع )رتسيلب(
ةحيوللا يوتحت
.تا
ّ
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ّ
وس
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ت لا دق
:هناونعو ليجستلا بحاصو ج
ِ
تن
ُ
ملا مسا
،.ض.م ةيودلأا ةعانصل عڨيت
اڨكت-حتيپ ،3190 .ب .ص
.ةحصلا ةرازو تاميلعت قفو 2021 طابش يف
ةرشنلا ريرحت مت
:ةح�

Charakterystyka produktu

Entecavir Teva 0.5mg and 1mg Tablets-LC-SPC 02/2021-notification
ENTECAVIR TEVA 0.5 MG AND 1 MG
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Teva 0.5 mg film-coated tablets
Entecavir Teva 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir-Teva 0.5 mg:
Each film coated tablet contains 0.5 mg entecavir (as monohydrate)
Entecavir-Teva 1 mg:
Each film coated tablet contains 1 mg entecavir (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Entecavir- Teva 0.5 mg film-coated tablets:
White to off-white, round-shaped tablet with “05” debossed on one
side of the tablet and “E” on the
other side.
Entecavir - Teva 1 mg film-coated tablets:
Light pink to pink, round-shaped tablet with deep score line, debossed
with "1" on one side of the tablet
and with “E/E” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir Teva is indicated for the treatment of chronic hepatitis B
virus (HBV) infection in adults with:
•
compensated liver disease, evidence of active viral replication, and
persistently elevated serum
alanine aminotransferase (ALT) levels.
•
decompensated liver disease.
_Paediatric population _
Entecavir Teva is not indicated for children and adolescents under 18
years old.
For both compensated and decompensated liver disease, this indication
is based on clinical trial data in
nucleoside naive patients with HBeAg positive and HBeAg negative HBV
infection. With respect to
patients with lamivudine-refractory hepatitis B, see sections 4.4 and
5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B
infection.
Posology
_ _
_Compensated liver disease_
_Nucleoside naive patients:_
the recommended dose in adults is 0.5 mg once daily, with or without
food.
_ _
_Lamivudine-refractory patients_
(i.e. with evidence of viraemia while on lamivudine or the presence of
lamivudine resistance [LV