ZUTECTRA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HUMAN HEPATITIS B IMMUNOGLOBULIN

Available from:

KAMADA LTD, ISRAEL

ATC code:

J06BB04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HUMAN HEPATITIS B IMMUNOGLOBULIN 500 IU

Administration route:

S.C

Prescription type:

Required

Manufactured by:

BIOTEST PHARMA GMBH, GERMANY

Therapeutic group:

HEPATITIS B IMMUNOGLOBULIN

Therapeutic area:

HEPATITIS B IMMUNOGLOBULIN

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.

Authorization date:

2018-06-30

Patient Information leaflet

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

Summary of Product characteristics

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