Zutectra 500units1ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hepatitis B immunoglobulin human

Available from:

Biotest (UK

INN (International Name):

Hepatitis B immunoglobulin human

Dosage:

500iu/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 04036124018399

Patient Information leaflet

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PACKAGE LEAFLET
2
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.
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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
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if you are allergic to human immunoglobulin or any of the other
ingredients of this medicine (listed
in section 6).
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 the skin) injection only.
Injection into a vein or a blood vessel may
result in allergic shock.
WARNINGS AND PRECAUTIONS
PLEASE TELL YOUR DOCTOR OR HEALTHCARE PROFESSIONAL PRIOR TO TREATMENT
-
if you

Summary of Product characteristics

OBJECT 1
ZUTECTRA
Summary of Product Characteristics Updated 05-Jan-2016 | Biotest (UK)
Ltd
1. Name of the medicinal product
Zutectra 500 IU solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
One pre-filled syringe of 1 ml 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:
IgG2:
IgG3:
IgG4:
59 %
35 %
3 %
3 %
IgA content max. 6,000 micrograms/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
The solution is clear and pale yellow or light brown.
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 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 on a weekly or fortnightly basis,
according to the serum an