Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
HUMAN HEPATITIS B IMMUNOGLOBULIN
KAMADA LTD, ISRAEL
J06BB04
SOLUTION FOR INJECTION
HUMAN HEPATITIS B IMMUNOGLOBULIN 500 IU
S.C
Required
BIOTEST PHARMA GMBH, GERMANY
HEPATITIS B IMMUNOGLOBULIN
HEPATITIS B IMMUNOGLOBULIN
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure.HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start.The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.
2018-06-30
هيف وأ اركع لولحملا نأب كتظحلام لاح يف ارتكتوز لامعتسإ زوجي لا ● .تائيزج يلديصلا لأسإ .ةيلزنملا ةمامقلا يف وأ يراجملا يف ةيودأ يمر زوجي لا ● لئاسولا هذه دعاست .لامعتسلإا ديق دعت مل ةيودأ نم صلختلا ةيفيك لوح .ةئيبلا ىلع ظافحلا يف ةيجاجزلا ةيعولأاو نقاحملا ،ربلإا ةفاك يمر بجي ،نقحلا ةيلمع مامتإ دعب .ةداحلا ءايشلأاب صاخ ءاعو ىلإ ً لااح ةغرافلا ةيفاضإ تامولعم )6 : ً اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي ● . Glycine and water for injections :ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك ● ةنقحم( نقحلل ةزهاج ةنقحم نمض نقحلل لولحم لكش ىلع رفوتم ارتكتوز رفوتم ارتكتوز .) IU 500 يوحت ارتكتوز للم 1 تاذ نقحلل ةزهاج ةدحاو .)رتسيلب( ةحيول ةوبع نمض ،نقحلل ةزهاج نقاحم 5 يوحت ةبلع نمض .بحاش رفصأ ىلإ نوللا ميدع نيب امو عملا ىلإ فافش نيب وه لولحملا نول .اماك تيب ،.ض.م عداماك :زايتملإا بحاص ● .ايناملأ ، Biotest Pharma GmbH :جتنملا ● .ةحصلا ةرازو تاميلعت بجومب 2022 ناسين يف اهدادعإ مت ● :ةحصلا ةرازو يف يموكحلا ةــيودلأا لجس يف ءاودــلا لجس مقر ● 1502633639 ج ِ لاعم لبق نم وأ يتاذلا نقحلاب ارتكتوز نقحت فيك ةءارق بجي .ارتكتوز ءاودلا نقح ةيفيك حرشل ةصصخم ةيلاتلا تاميلعتلا مقاطلا وأ بيبطلا موقي .ىرخلأا ولت ةوطخ اهقفو فرصتلاو نعمتب تاميلعتلا .ءاطعلإا ةريسم لوح كداشرإب يبطلا لولحم ريضحت Olvassa el a teljes dokumentumot
1 ZUTECTRA 1. NAME OF THE MEDICINAL PRODUCT Zutectra 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin One mL contains: Human hepatitis B immunoglobulin 500 IU (purity of at least 96% IgG) Each pre-filled syringe of 1 mL solution contains: 150 mg of human protein, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU. Distribution of IgG subclasses (approx. values): IgG1: 59 % IgG2: 35 % IgG3: 3 % IgG4: 3 % The maximum IgA content is 6,000 micrograms /mL. Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear to opalescent and colourless to pale yellow with a pH of 5.0-5.6 and an osmolality of 300-400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re- infection prophylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology In HBV-DNA negative adults at least one week after liver transplantation: 2 - subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels. Prior to the initiation of subcutaneous treatment with Zutectra, adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/L in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing. Antibody levels >100 IU/L should be maintained in HBsAg and HBV-DNA negative patients. The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections o Olvassa el a teljes dokumentumot