Zutectra

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

human hepatitis B immunoglobulin

Saatavilla:

Biotest Pharma GmbH

ATC-koodi:

J06BB04

INN (Kansainvälinen yleisnimi):

human hepatitis B immunoglobulin

Terapeuttinen ryhmä:

Immune sera and immunoglobulins,

Terapeuttinen alue:

Immunization, Passive; Hepatitis B; Liver Transplantation

Käyttöaiheet:

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.,

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-11-30

Pakkausseloste

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZUTECTRA 500 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Human hepatitis B immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zutectra is and what it is used for
2.
What you need to know before you use Zutectra
3.
How to use Zutectra
4.
Possible side effects
5.
How to store Zutectra
6.
Contents of the pack and other information
7.
How to inject Zutectra by yourself or by caregiver
1.
WHAT ZUTECTRA
IS AND WHAT IT IS USED FOR
WHAT ZUTECTRA IS
Zutectra contains antibodies against the hepatitis B virus which are
the body's own defensive
substances to protect you from hepatitis B. Hepatitis B is an
inflammation of the liver caused by the
hepatitis B virus.
WHAT ZUTECTRA IS USED FOR
Zutectra is used to prevent re-infection of hepatitis B in adults who
have had a liver transplant at least
1 week ago because they had liver failure caused by hepatitis B.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZUTECTRA
DO NOT USE ZUTECTRA
-
if you are allergic to human immunoglobulin or any of the other
ingredients of this medicine (listed
in section 6). In particular, in very rare cases of insufficient
amount of immunoglobulin A (IgA),
when you have antibodies against IgA in your blood. This might lead to
severe allergic reaction
(anaphylaxis).
An allergic reaction may include sudden wheeziness, difficulty in
breathing, fast pulse, swelling of the
eyelids, face, lips, throat or tongue, rash or itching.
Zutectra is for subcutaneous (under

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zutectra 500 IU solution for injection in pre-filled syringe
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 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
3
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 5