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HUMAN RABIES IMMUNOGLOBULIN NOT LESS THAN 150 IU/ML SOLUTION FOR INJECTION

Active substance(s): RABIES IMMUNOGLOBULIN

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SRCNL4

PATIENT INFORMATION LEAFLET
HUMAN RABIES
IMMUNOGLOBULIN
NOT LESS THAN 150 IU/mL 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 Rabies Immunoglobulin is and what it is used for
2. Before you are given Human Rabies Immunoglobulin
3. How you are given Human Rabies Immunoglobulin
4. Possible side effects
5. How to store Human Rabies Immunoglobulin
6. Further information

1. WHAT HUMAN RABIES IMMUNOGLOBULIN IS
AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of rabies antibodies. It
is prepared from blood plasma from screened donors and virally-inactivated
during manufacture.
It is used to protect you against rabies and is given with first dose of rabies
vaccine, or not more than 7 days later. Your doctor will explain further why this
medicine has been given to you.
This product is usually given to you if:
• you have been bitten, scratched or received any other injury from a
suspected rabid animal or you may have swallowed or breathed in tissue
such as saliva from a suspected rabid animal.
Human Rabies Immunoglobulin is given by injection around the wound and
into the muscle at the side of the thigh (intramuscular). Your doctor or nurse
will give you the injection.

2. BEFORE YOU ARE GIVEN
HUMAN RABIES IMMUNOGLOBULIN
Special care must be taken with Human Rabies 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. Inform your doctor if this is the case.
• have already had this product recently. Tell your doctor as the previous
injection may interfere with rabies vaccine.
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 RABIES IMMUNOGLOBULIN
This product must be injected by a doctor or nurse. Human Rabies
Immunoglobulin must not be injected into a vein. It is for injecting around the
bite wound and the rest of the dose into the side of the thigh.
Doses
20 IU/kg body weight at the same time as the first dose of rabies vaccine or not
more than 7 days later.
Your doctor will advise you on the dose for you.

4. POSSIBLE SIDE EFFECTS
As with all medicines, Human Rabies Immunoglobulin may cause side effects,
although not everybody gets them.
Allergic reactions can occur, which may include tightening in the throat or
chest, tongue swelling, swelling beneath the skin particularly around the lips
and eyes, hives (urticaria), wheezing or flushing. These can progress to shock.
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.
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 RABIES 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, dispose of any solution that remains,
along with used syringes, needles and containers. Your doctor will do this.
Medicines should not be disposed of via wastewater or household waste.

6. FURTHER INFORMATION
What Human Rabies Immunoglobulin contains
The active substance is immunoglobulin containing a specifically high
concentration of antibodies (not less than 150 IU/mL) to the rabies virus.
The other ingredients are: glycine, sodium chloride, sodium acetate and a
small quantity of sodium hydroxide.
What Human Rabies Immunoglobulin looks like and the contents of the pack
Human Rabies Immunoglobulin is a clear to slightly cloudy, colourless to pale
yellow sterile solution, available as single dose vials containing 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 08801/0014
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

Version: SRCNL4

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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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