ZUTECTRA SOLUTION FOR INJECTION 500 IUML

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Human Hepatitis B Immunoglobulin in 150g/l human plasma protein (IgG ≥ 96%)

Διαθέσιμο από:

ESHCOL PHARMACEUTICAL GROUP SINGAPORE PTE LTD

Φαρμακολογική κατηγορία (ATC):

J06BB04

Δοσολογία:

500 iu/ml

Φαρμακοτεχνική μορφή:

INJECTION

Σύνθεση:

Human Hepatitis B Immunoglobulin in 150g/l human plasma protein (IgG ≥ 96%) 500 iu/ml

Οδός χορήγησης:

SUBCUTANEOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Vetter Pharma-Fertigung GmbH Co. KG (filling, packing and labelling)

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2014-10-24

Φύλλο οδηγιών χρήσης

ACTIVE SUBSTANCE
Human  hepatitis  B  immunoglobulin  for  subcutaneous  adminis-
tration
COMPOSITION
One pre-filled syringe of 1ml contains Human hepatitis B immuno-
globulin 500 IU.
Human  protein  150  mg/ml  of  which  at  least  96%  is  IgG,  with  a 
content of antibodies to hepatitis B virus surface antigen (HBs) of
500 IU/ml.
Distribution  of  IgG  subclasses:  IgG1:  59%,  IgG2:  35%,  IgG3:  3%, 
IgG4: 3%
IgA content max. 6,000 micrograms/ml.
Excipients: Glycine, water for injections
PHARMACEUTICAL FORM AND PRESENTATIONS
Solution for injection in pre-filled syringe
Pack size of five syringes in a blistered pack.
PHARMACOTHERAPEUTIC GROUP
Specific immunoglobulins, ATC code: J06BB04
NAME AND ADDRESS OF MANUFACTURER
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Ger-
many
INDICATIONS
Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA nega-
tive patients ≥ 6 months after liver transplantation for hepatitis B 
induced liver failure.
Zutectra is indicated in adults only.
The concomitant use of adequate virostatic agents should be con-
sidered, if appropriate, as standard of hepatitis B re-infection proph-
ylaxis.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In HBV-DNA negative adults ≥ 6 months after
liver transplantation:
- patients with bodyweight < 75 kg: 500 IU (1 ml)/week
- patients with bodyweight ≥ 75 kg: 1,000 IU
(2 times 1 ml)/week
Package Leaflet
500 IU solution for injection in pre-filled syringe
Prior  to  the  initiation  of  subcutaneous  treatment  with  Zutectra, 
anti-HBs  serum  levels  should  be  stabilized  with  an  adequate  in-
travenous hepatitis B immunoglobulin  to levels at or above 300-
500 IU/l. The first Zutectra dose should be administered approxi-
mately 14-21 days after the last intravenous dose at stabilized anti-
HBs serum levels i

Αρχείο Π.Χ.Π.

Package Leaflet
ZUTECTRA®
500 IU solution for injection in pre-filled syringe
ACTIVE SUBSTANCE
Human hepatitis B immunoglobulin for subcutaneous administration
COMPOSITION
One pre-filled syringe of 1ml contains Human hepatitis B
immunoglobulin 500 IU.
Human protein 150 mg/ml of which at least 96% is IgG, with a content
of antibodies to hepatitis B virus
surface antigen (HBs) of 500 IU/ml.
Distribution of IgG subclasses: IgG1: 59%, IgG2: 35%, IgG3: 3%, IgG4:
3%
The maximum IgA content is 6,000 micrograms/ml.
Excipients: Glycine, water for injections
PHARMACEUTICAL FORM AND PRESENTATIONS
Solution for injection in pre-filled syringe
Pack size of five syringes in a blistered pack.
PHARMACOTHERAPEUTIC GROUP
Specific immunoglobulins, ATC code: J06BB04
NAME AND ADDRESS OF MANUFACTURER
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany
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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In HBV-DNA negative adults at least one week after liver
transplantation 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
stabilized 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