BARACLUDE 0.5 MG

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

ENTECAVIR; ENTECAVIR

Sẵn có từ:

BRISTOL - MYERS SQUIBB, ISRAEL

Mã ATC:

J05AF10

Dạng dược phẩm:

FILM COATED TABLETS

Thành phần:

ENTECAVIR 0.5 MG; ENTECAVIR 0.5 MG

Tuyến hành chính:

PER OS, PER OS

Loại thuốc theo toa:

Required

Sản xuất bởi:

BRISTOL MYERS SQUIBB S.R.L, ITALY

Nhóm trị liệu:

ENTECAVIR

Khu trị liệu:

ENTECAVIR

Chỉ dẫn điều trị:

Baraclude 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. Baraclude 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.

Ngày ủy quyền:

2014-01-31

Tờ rơi thông tin

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ןכרצל
ןכרצל
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
5.1.2014
םש
רישכת
תילגנאב
רפסמו
םושירה
BARACLUDE 0.5 MG 140 13 31922 00; BARACLUDE 1 MG 140 14 31923 00
םש
לעב
םושירה
BRISTOL-MYERS SQUIBB ISRAEL LTD
.
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
ןיא יתמ
שמתשהל
?
רישכתב
ליגל תחתמ םירגבתמו םידליב שומישל
תדעוימ הניא הפורתה
18
ינש
ם
.וז ליג תצובקב וחכוה םרט הפורתה
תוליעיו תוחיטבש ןוויכמ
:
הקנהו ןוירה
ץעוויהל שי ,וז הפורתב לופיטה תפוקתב
ןוירהל סנכיהל ןיא
תאז לכב םא .םיתואנ העינמ יעצמאב שומישל
רשאב אפורב
לופיטה קיספהל שי ,הפורתה תליטנ ךלהמב
ןוירהל תסנכנ
.אפורל דיימ תונפלו הפורתב
םירחא תקבדה לש תורשפא תענומ הניא
הפורתה תליטנ
בושח ןכ לע ,)עוגנ םד ןוגכ ( ףוג ילזונ וא
ינימ עגמ תועצמאב
דגנכ ןוסיח םייק :ךתעידיל .םימיאתמ
תוריהז יעצמאב טוקנל
סיטיטפה
B
םיאצמנ רשא םישנא לע הנגהב עייסל יושע
רשא
.הקבדהל הובג ןוכיסבו ךתיא בורק עגמב
רשאב אפורב ץעוויהל שי ,וז הפורתב
לופיטה תפוקתב ןוירהל סנכיהל ןיא
םיתואנ העינמ יעצמאב שומישל
.
לופיטה קיספהל שי ,הפורתה תליטנ ךלהמב
ןוירהל תסנכנ תאז לכב םא
אפורל דימ תונפלו הפורתב
.
חכוה םרט .ןוירהל סנכיהל תננכתמ וא
ןויריהב תא םא אפורה תא עדייל שי
.ןוירהה ךלהמ

Đặc tính sản phẩm

_ _
_ _
_ _
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and _
_ approved by it in Nov 2016 _
_ _
BARACLUDE 0.5 MG AND 1 MG
PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Baraclude 0.5 mg film-coated tablets
Baraclude 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
U
Baraclude 0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir
U
Baraclude 1 mg film-coated tablets
Each tablet contains 1 mg entecavir
Excipients with known effect:
Each 0.5 mg tablet contains 120.5 mg lactose.
Each 1 mg tablet contains 241 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
U
Baraclude 0.5 mg film-coated tablets
white to off-white and triangular-shaped tablet with “BMS”
debossed on one side and “1611” on the
other.
U
Baraclude 1 mg film-coated tablets
pink and triangular-shaped tablet with “BMS” debossed on one side
and “1612” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baraclude 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
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.
U
Posology
_Compensated liver disease _
_Nucleoside naïve 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 [LVDr] mutations) (se