Страна: Израиль
Язык: английский
Источник: Ministry of Health
LAMIVUDINE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF05
TABLETS
LAMIVUDINE 100 MG
PER OS
Required
GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND
LAMIVUDINE
LAMIVUDINE
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.
2014-05-31
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 Прочитать полный документ
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 Прочитать полный документ