ZEFFIX TABLETS

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

LAMIVUDINE

Sẵn có từ:

GLAXO SMITH KLINE (ISRAEL) LTD

Mã ATC:

J05AF05

Dạng dược phẩm:

TABLETS

Thành phần:

LAMIVUDINE 100 MG

Tuyến hành chính:

PER OS

Loại thuốc theo toa:

Required

Sản xuất bởi:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Nhóm trị liệu:

LAMIVUDINE

Khu trị liệu:

LAMIVUDINE

Chỉ dẫn điều trị:

Zeffix is indicated for the treatment of chronic hepatitis B associated with the evidence of hepatitis B viral (HBV) replication and active liver inflammation in adults and also in children and adolescents aged 2 to 17 years old.

Ngày ủy quyền:

2014-05-31

Tờ rơi thông tin

The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved by the Ministry of Health in
December 2017, and was updated in accordance with the Ministry of
Health
guidelines in February 2019
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
ZEFFIX TABLETS
Each tablet contains 100 mg lamivudine.
The list of additional ingredients is detailed in section 6. Note
important
information about some of the ingredients of the medicine in Section
2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
This medicine is intended for adults and children above the age of 2
years.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Zeffix is a medicine used to treat chronic hepatitis B virus (HBV) in
adults and
children above the age of 2
years
(there is an oral solution for children).
It is not known if Zeffix is safe and effective for:
∙ people with chronic HBV who have a severely damaged liver that is
unable to
work properly (decompensated liver disease)
∙ people with HIV-1, hepatitis C virus or hepatitis D (delta) virus
∙ people who have had a liver transplant
THERAPEUTIC GROUP: Nucleoside analogue reverse transcriptase
inhibitors
(NRTIs).
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
you are sensitive (allergic) to lamivudine or to any of the additional
ingredients contained in the medicine (listed in section 6).
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE
BEFORE BEGINNING TREATMENT WITH ZEFFIX, TELL YOUR PHYSICIAN ABOUT ALL
OF
YOUR HEALTH CONDITIONS, INCLUDING IF:
∙ You have an HIV-1 infection
∙ You have kidney problems
∙ You are pregnant or plan to become

Đặc tính sản phẩm

Page 1 of
20
טמרופ
ןולע
הז
עבקנ
ע
"
י
דרשמ
תואירבה
ונכותו
קדבנ
רשואו
ע
"
י
דרשמ
תואירבה
:ךיראתב
רבמצד
2017
,
ןכדועו
םאתהב
תוארוהל
דרשמ
תואירבה
ךיראתב
ראורבפ
2019
_ _
ZEFFIX
TABLETS ZEFFIX ORAL SOLUTION
WARNING:
EXACERBATIONS
OF
HEPATITIS
B
AND
RISK
OF
HIV-1
RESISTANCE IF
ZEFFIX
IS USED IN PATIENTS WITH UNRECOGNIZED
OR
UNTREATED HIV-1
INFECTION
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO
HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY (INCLUDING ZEFFIX). HEPATIC
FUNCTION
SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY
FOLLOW-UP FOR AT
LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE ANTI-HEPATITIS B
THERAPY. IF
APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED
_[SEE _
_WARNINGS AND PRECAUTIONS (5.1)]. _
ZEFFIX IS NOT APPROVED FOR THE TREATMENT OF HIV-1 INFECTION BECAUSE
THE
LAMIVUDINE DOSAGE IN ZEFFIX IS SUBTHERAPEUTIC AND MONOTHERAPY IS
INAPPROPRIATE
FOR THE TREATMENT OF HIV-1 INFECTION. HIV-1 RESISTANCE MAY EMERGE IN
CHRONIC
HEPATITIS B-INFECTED PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1
INFECTION.
HIV COUNSELING AND TESTING SHOULD BE OFFERED TO ALL PATIENTS BEFORE
BEGINNING
TREATMENT WITH ZEFFIX AND PERIODICALLY DURING TREATMENT _[SEE WARNINGS
AND _
_PRECAUTIONS (5.2)]_.
1
INDICATIONS AND USAGE
ZEFFIX is indicated for the treatment of chronic hepatitis B virus
(HBV) infection associated
with evidence of hepatitis B viral replication and active liver
inflammation in adults and also
in children and adolescents aged 2 to 17 years old.
_See Clinical Studies (14.1, 14.2)_
.
_ _
The following points should be considered when initiating therapy with
ZEFFIX:
•
Due to high rates of resistance development in treated patients,
initiation of
treatment with
ZEFFIX
should only be considered when the use of an alternative
antiviral agent with a higher genetic barrier to resistance is not
available or
appropriate.
•
ZEFFIX
has not been evaluated in patie