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HUMAN HEPATITIS B IMMUNOGLOBULIN 100 IU/ML STERILE SOLUTION

Active substance(s): HUMAN HEPATITIS B IMMUNOGLOBULIN

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PATIENT INFORMATION LEAFLET
HUMAN HEPATITIS B
IMMUNOGLOBULIN
100 IU/mL STERILE SOLUTION

Please read all of this leaflet carefully before using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for you personally.
Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
Is this leaflet hard to see or read? Phone +44 (0)20 8957 2200.
In this leaflet:
1. What Human Hepatitis B Immunoglobulin is and what it is used for
2. Before you are given Human Hepatitis B Immunoglobulin
3. How you are given Human Hepatitis B Immunoglobulin
4. Possible side effects
5. How to store Human Hepatitis B Immunoglobulin
6. Further information

1. WHAT HUMAN HEPATITIS B IMMUNOGLOBULIN
IS AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of hepatitis B antibodies.
It is prepared from blood plasma from screened donors and virally-inactivated
during manufacture. It is used to protect against infection by the hepatitis B
virus and is normally given with hepatitis B vaccine. Your doctor will explain
further why this medicine has been given to you.
This product is usually given to you if:
• you have not had previous vaccination, or have not been properly
vaccinated, to hepatitis B and have been accidentally exposed to infection
by skin pricks, cuts, spillage into the eye or mouth, from infectious material
such as blood, or from bites.
• you are having kidney dialysis while waiting for vaccination to be fully
effective.
• you have not responded to hepatitis B vaccination, but you remain at risk of
infection, perhaps because of your job.
• you are within seven days of sexual contact with someone who has hepatitis B.
The product can also be given to newborn babies whose mother has hepatitis B.
Human Hepatitis B Immunoglobulin does not work if you already have hepatitis
B. A blood test to see whether you have the infection may be done before
injection. However, the injection should not be delayed for more than 48 hours
after you have been exposed to a possible hepatitis B infection. In any case,
the dose should be given within one week after exposure to the infection.
Human Hepatitis B Immunoglobulin is given by injection into a muscle
(intramuscular) such as the buttock or thigh. Your doctor or nurse will give you
the injection.

2. BEFORE YOU ARE GIVEN
HUMAN HEPATITIS B IMMUNOGLOBULIN
You must not be given this medicine if you are:
• suffering from any blood disorders which interfere with clotting
• allergic to any of the ingredients in this product (see Section 6 ‘Further
Information’ for a list of these).
Special care must be taken with Human Hepatitis B Immunoglobulin if you:
• develop an allergic reaction (see Section 4 ‘Possible Side Effects’ for a list of
these). If you suffer from any of these, or just feel unwell, tell your doctor.
• suffer from a blood disorder. Inform your doctor before this medicine is
injected. Your doctor or nurse may inject this product just under the skin
under these circumstances.
• have had any vaccinations recently or know you are about to have any
vaccinations. Tell your doctor if this is the case.
• have had this product recently as it may give misleading results if you have
a blood test. Tell your doctor if this is the case.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other
medicines, including those obtained without a prescription.
This solution for injection must not be mixed with other medicinal products for
injection.
Your doctor will advise you about any vaccinations you may need in addition to
giving you this product.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or are
breastfeeding before this medicine is injected.
Driving and using machines
There are no known effects of this product on your ability to drive or operate
machinery.

3. HOW YOU ARE GIVEN HUMAN HEPATITIS B
IMMUNOGLOBULIN
This product must always be injected by a doctor or nurse. Human Hepatitis B
Immunoglobulin must never be injected into a vein; it must be injected slowly
into a large muscle such as the buttock or thigh.
Doses
After accidental exposure to possible hepatitis B infection:
Adults:
The dose is at least 500 IU.
Children:
10 years and older: 500 IU (as adult);
5 to 9 years: 300 IU;
Birth to 4 years: 200 IU.
A second dose is usually given 4 weeks later. Your doctor will advise you on the
dose for you and whether you need a second dose.
On kidney dialysis a dose of 8 to 12 IU/kg body weight (maximum 500 IU) is
given every 2 months while waiting for vaccination to become fully effective.
Newborns whose mother has hepatitis B a dose of 30 to 100 IU/kg is given,
preferably within 24 hours of birth. Further doses may be necessary until
vaccination has become fully effective.
Within one week of sexual contact with a person with hepatitis B, the dose is
at least 500 IU.

4. POSSIBLE SIDE EFFECTS
As with all medicines, Human Hepatitis B Immunoglobulin may cause side
effects, although not everybody gets them.
There may be some short term discomfort at the site of injection. Very rarely a
hardened area may develop where the injection was given. The following have
been reported after injection:
chest pain,
shortness of breath,
shaking,
dizziness,
swelling of the face,
coating of the tongue,
mouth ulcers,
joint pains,
slight fever.
If you get any of these or continuous pain, itching, rash or any other reaction or
just feel unwell, you must tell your doctor.
Please note
When medicines are made from human blood or plasma, certain measures
are put in place to prevent infections being passed on to patients. These
include: – careful selection of blood and plasma donors to make sure those
at risk of carrying infections are excluded, – the testing of each donation
and pools of plasma for signs of virus/infections, – the inclusion of steps in
the processing of the blood or plasma that can inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or
plasma are administered, the possibility of passing on infection cannot be
totally excluded. This also applies to any unknown or emerging viruses or other
types of infections. The measures taken are considered effective for enveloped
viruses such as human immunodeficiency virus (HIV), hepatitis B virus and
hepatitis C virus, and for the nonenveloped hepatitis A and parvovirus B19
viruses. The measures taken are considered effective for enveloped viruses
such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis
C virus and for the non-enveloped viruses such as hepatitis A and parvovirus
B19. Immunoglobulins have not been associated with hepatitis A or parvovirus
B19 infections possibly because the antibodies against these infections, which
are contained in the product, are protective.

5. HOW TO STORE HUMAN HEPATITIS B IMMUNOGLOBULIN
• Keep out of the reach and sight of children.
• You should store the medicine in its carton to protect it from light, in the
refrigerator (2-8°C). Do not freeze. Short periods (up to one week) of storage
at room temperature (25°C), in the dark, will not damage the product.
• Do not use the medicine after the expiry date which is printed as “EXP” on
the containers (the expiry date refers to the last day of the month stated).
• Do not use the medicine if it is cloudy or any small bits can be seen in it.
Disposal
After injection of the correct dose, your doctor or nurse will dispose of any
solution that remains, along with used syringes, needles and containers.
Medicines should not be disposed of via wastewater or household waste.

6. FURTHER INFORMATION
What Human Hepatitis B Immunoglobulin contains
The active substance is immunoglobulin containing a high concentration of
antibodies (not less than 100 IU/mL) to hepatitis B.
The other ingredients are: glycine, sodium chloride, sodium acetate and a
small quantity of sodium hydroxide.
What Human Hepatitis B Immunoglobulin looks like and the contents of the pack
Human Hepatitis B Immunoglobulin is a clear to slightly cloudy, colourless to
pale yellow sterile solution, available as single dose vials containing either
200 IU or 500 IU in glass vials. These vials are closed with a synthetic rubber
stopper, held on by an aluminium ring and flip off cover.
Marketing Authorisation Holder and manufacturer
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire,
WD6 3BX, United Kingdom
Marketing Authorisation Number PL 08801/0012
For further information or if you have any questions about the use of this
product, please contact BPL via the Marketing Department at the address
above or through info@bpl.co.uk
December 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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