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HUMAN VARICELLA-ZOSTER IMMUNOGLOBULIN 250MG SOLUTION FOR INJECTION

Active substance: HUMAN VARICELLA ZOSTER IMMUNOGLOBULIN

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PATIENT INFORMATION LEAFLET
HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN 250MG
SOLUTION FOR INJECTION

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 Varicella-Zoster Immunoglobulin is and what it is used for
2. Before you use Human Varicella-Zoster Immunoglobulin
3. How to use Human Varicella-Zoster Immunoglobulin
4. Possible side effects
5. How to store Human Varicella-Zoster Immunoglobulin
6. Further information

1. WHAT HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN IS AND WHAT IT IS USED FOR
Varicella-zoster is a virus which causes chicken pox (varicella) and shingles.
This product is a solution containing a large quantity of varicella-zoster
immunoglobulin (antibodies) which the body produces to provide protection
against infection with this virus. It is prepared from blood plasma from
screened donors and virally-inactivated during manufacture.
It is used to protect against infection by the varicella-zoster virus (VZV). Your
doctor will explain further why this medicine has been given to you.
This product is usually given to:
• newborn babies whose mothers develop chickenpox (varicella) within 7 days
before and 7 days after baby’s birth
It is also given to the following individuals who have come into contact with a
person who has chickenpox or shingles:
• pregnant women with no antibodies to VZV especially up to about 30 weeks
of pregnancy
• newborn babies whose mother has never had chickenpox (varicella) and/or
is not immune
• premature infants less than 28 weeks of gestation or newborns with low
birth weight
• adults and children who have never had chickenpox (varicella) and/or are not
immune, and whose immune response is reduced by certain medicines such
as steroids, anti-cancer drugs or by certain treatments such as radiotherapy
or recent stem cell transplantation
• adults and children who have a reduced immune system which makes them
more likely to have infections such as chicken pox or shingles unless they are
receiving other types of regular immunoglobulin treatment.
Human Varicella-Zoster Immunoglobulin is given by injection into a muscle
(intramuscular) such as the buttock or thigh.

2. BEFORE YOU ARE GIVEN HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN
You must not be given this medicine if you are:
• allergic to human immunoglobulins
• 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 Varicella-Zoster 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.

MyGPS Europe Limited

Tel: 020 8863 9700

Job No: 1905

Laura Ambrose

Client Order No.

P13280

10/12/2014

Proof No.

3

Hema Joshi

Doc. Size:

90 x 290mm

Project Name:

Human Varicella Zoster PIL UK

Contact:
Date:
Operator:

uman Varicella Zoster PIL UK3.indd 1

10/12/2014

3. HOW TO USE HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN
This product must always be injected by a doctor or nurse. Human VaricellaZoster Immunoglobulin must never be injected into a vein and must be injected
slowly into a large muscle such as the buttock or thigh.
Human Varicella-Zoster Immunoglobulin may be injected just under the skin,
your doctor will advise on this or may use an alternative intravenous product.
Doses
At least 15 IU/kg body weight should be given as soon as possible, ideally
within 3 days but certainly within 10 days of a contact with a person who has
chickenpox or shingles.
As a guide, alternative dose levels for treatment are as follows:
0 - 5 years
250 mg (1 vial)
6 - 10 years
500 mg (2 vials)
11 - 14 years 750 mg (3 vials) 15 years and older 1,000 mg (4 vials)
If a second contact with a person who has chickenpox or shingles occurs three
weeks or more after the first dose, a second dose must be given.

4. POSSIBLE SIDE EFECTS
As with all medicines, Human Varicella-Zoster Immunoglobulin may cause side
effects, although not everybody gets them.
There may be some short term swelling, warmth, pain, redness, wound itching or
rash at the injection site.
A hardened area may develop where the injection was given.
The following may also occur after injection:
• allergic reactions, which may be serious with difficulty in breathing or dizziness
• lightheaded, fainting or feeling faint • rapid heart beat
• headache
• feeling or being sick
• chills, fever
• joint pains
• itching, redness of the skin
if you get any of these or notice any side-effects not listed in this leaflet, 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. 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 VARICELLA-ZOSTER
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 Varicella-Zoster Immunoglobulin contains
The active substance is immunoglobulin containing a high concentration of
antibodies to varicella-zoster virus.
The other ingredients are: glycine, sodium chloride, sodium acetate and sodium
hydroxide.
What Human Varicella-Zoster Immunoglobulin looks like and the contents of
the pack
Human Varicella-Zoster Immunoglobulin is a clear to slightly cloudy, colourless
to pale yellow sterile solution, available as single dose glass vials containing
250 mg. 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 08801/0013
This leaflet was last approved in December 2014
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.
Version SZDNL3

MyGPS Europe Limited

Tel: 020 8863 9700

Job No: 1905

Laura Ambrose

Client Order No.

P13280

10/12/2014

Proof No.

3

Hema Joshi

Doc. Size:

90 x 290mm

Project Name:

Human Varicella Zoster PIL UK

Contact:
Date:
Operator:

uman Varicella Zoster PIL UK3.indd 2

10/12/2014

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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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