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

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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.  HAT HUMAN VARICELLA-ZOSTER
W
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.
Human Varicella-Zoster Immunoglobulin is given by injection into a muscle
(intramuscular) such as the buttock or thigh. 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.
2.  EFORE YOU ARE GIVEN HUMAN VARICELLA-ZOSTER
B
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.



3.  OW TO USE HUMAN VARICELLA-ZOSTER
H
IMMUNOGLOBULIN
This product must always be injected by a doctor or nurse. Human Varicella-Zoster
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 EFFECTS
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, and the testing of each donation and pools of plasma for
signs of virus/infections. Manufacturers of these products also include 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. The measures
taken may be of limited value against 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.
It is strongly recommended that every time you receive a dose of Human VaricellaZoster Immunoglobulin the name and batch number of the product are recorded in
order to maintain a record of the batches used.
Please remember
Since chicken pox in pregnancy, in newborn babies or in patients whose immune
system is not working fully can have serious effects on health, the expected benefits
of your medicine will usually be greater than the risks of suffering any harmful side
effects.
5.  OW TO STORE HUMAN VARICELLA-ZOSTER
H
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 November 2012
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.


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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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