ZEFFIX ORAL SOLUTION

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

LAMIVUDINE

Prieinama:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kodas:

J05AF05

Vaisto forma:

SOLUTION (ORAL)

Sudėtis:

LAMIVUDINE 5 MG/ML

Vartojimo būdas:

PER OS

Recepto tipas:

Required

Pagaminta:

GLAXO SMITH KLINE INC., CANADA

Farmakoterapinė grupė:

LAMIVUDINE

Gydymo sritis:

LAMIVUDINE

Terapinės indikacijos:

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.

Leidimo data:

2013-10-31

Pakuotės lapelis

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
ZEFFIX ORAL SOLUTION
Each 1 ml of oral solution contains 5 mg lamivudine.
For the list of inactive and allergenic ingredients, see section 2 -
“Important
information about some of the ingredients of the medicine” and
section 6 -
“Further information”.
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.
THERAPEUTIC GROUP: Nucleoside analogue reverse transcriptase
inhibitors (_NRTIs_).
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
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 have diabetes. Each 20 ml (100 mg) dose of Zeffix Oral Solution
contains 4 grams sucrose.
∙
You are pregnant or plan to become pregnant. It is not known
whether Zeffix will harm your unborn baby.
∙
You are breastfeeding or plan to breastfeed. Ze

Prekės savybės

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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 HUMAN IMMUNODEFICIENCY
VIRUS TYPE
1 (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 patients co-infected with human
immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis
delta virus.
•
ZEFFIX has not been evaluated in liver transplant recipients or in
patients with
chronic hepatitis B virus infe