HUMAN TETANUS IMMUNOGLOBULIN 100 IU/ML SOLUTION FOR INJECTION
Active substance(s): HUMAN TETANUS IMMUNOGLOBULIN / HUMAN TETANUS IMMUNOGLOBULIN / HUMAN TETANUS IMMUNOGLOBULIN
PATIENT INFORMATION LEAFLET
100 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 Tetanus Immunoglobulin is and what it is used for
2. Before you are given Human Tetanus Immunoglobulin
3. How you are given Human Tetanus Immunoglobulin
4. Possible side effects
5. How to store Human Tetanus Immunoglobulin
6. Further information
1. WHAT HUMAN TETANUS IMMUNOGLOBULIN IS
AND WHAT IT IS USED FOR
This product is a solution containing a large quantity of tetanus antibodies.
It is prepared from blood plasma from screened donors and virally-inactivated
during manufacture. It is used to protect you against tetanus and is normally
given with tetanus 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 to tetanus, or have not been properly
vaccinated, or do not know whether you have been vaccinated to tetanus but
may have recently been exposed to tetanus because you have been wounded
e.g by a cut, bite or pierced by a foreign body
• you have had a full course of vaccination to tetanus but have recently had a
severe injury with a high risk of being infected by tetanus germs
Human Tetanus Immunoglobulin is given by injection into a muscle
(intramuscular) such as the buttock or thigh. Your doctor or nurse will give you
2. BEFORE YOU ARE GIVEN
HUMAN TETANUS 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 Tetanus 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
• 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
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
3. HOW YOU ARE GIVEN
HUMAN TETANUS IMMUNOGLOBULIN
This product must always be injected by a doctor or nurse. Human Tetanus
Immunoglobulin must never be injected into a vein; it must be injected slowly
into a large muscle such as the buttock or thigh.
As a precaution 250 IU will be given (this is the contents of one vial) and this
may be increased to 500 IU (two vials) if your wound is more serious.
Your doctor will advise you on the dose for you.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Human Tetanus 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 may also occur after injection:
shortness of breath,
swelling of the face,
coating of the tongue,
If you get any of these or continuous pain, itching, rash or any other reaction
or just feel unwell, you must tell your doctor.
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 TETANUS 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.
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 Tetanus Immunoglobulin contains
The active substance is immunoglobulin containing a speciﬁcally high
concentration of antibodies (not less than 100 IU/mL) to the poison produced
by the germ which causes tetanus.
The other ingredients are: glycine, sodium chloride, sodium acetate and a
small quantity of sodium hydroxide.
What Human Tetanus Immunoglobulin looks like and the contents of the pack
Human Tetanus Immunoglobulin is a clear to slightly cloudy, colourless to pale
yellow sterile solution, available as single dose vials containing 250 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 08801/0011
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 email@example.com.
This leaﬂet was last revised in December 2014
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.