Tetanus Immunoglobulin (IM)

Presentation
Single vials containing 250 IU human tetanus antitoxin.

Indications for Use

• Passive protection of individuals who have sustained a tetanus-prone wound and who have
either not been actively immunised against tetanus or whose immunisation history is doubtful.
• Passive protection of fully immunised individuals with a tetanus prone wound if more than 10
years have elapsed since the last dose of toxoid or vaccine. In the above instances, active
immunisation with tetanus vaccine should be commenced simultaneously. Types of wounds
likely to favour the growth of tetanus organisms are compound fractures, deep penetrating
wounds, wounds containing foreign bodies (especially wood splinters), wounds complicated by
pyogenic infections, wounds with extensive tissue damage, any superficial wound contaminated
with soil, dust or horse manure, especially if topical disinfection is delayed more than 4 hours.

Contraindications
Individuals with:
• IgA deficiency – unless they have no circulating anti IgA antibodies.
• Severe thrombycytopenia or coagulation disorder that would contraindicate IM injections.

Precautions
Administer by intramuscular injection. MUST NOT be administered intravenously.
Care should be taken to draw back plunger of syringe before injection to be certain needle is not in a
vessel.
Give with caution to patients with a history of prior systemic allergic reactions to human
immunoglobulin preparations.

Availability
Requests to ARCBS.

Dosage and Administration

Tetanus Immunoglobulin for adults and children is given by slow intramuscular injection.
Bring to room temperature prior to administration.
Dosage – minimum routine prophylactic dose is 250IU for adults and children.
The dose should be doubled if the wound is grossly contaminated or if more than 24 hours have elapsed
between wounding and seeking of medical attention.
The product s does not contain antimicrobial preservative; it must be used immediately after opening
the vial.
Refer to the current product information sheet for further information.

Human Tetanus immunoglobulin Q & A

What has caused the shortage?

The one manufacturer had production problems with the product.

How long is the shortage expected to last?

Supplies may not be restored until the end of August 2007.

Is stock available for emergency treatment of Tetanus cases?

Yes. Stock is available for emergency treatment of tetanus infection and can be ordered by
telephoning Bio Products Laboratory Customer Services on 020 8258 2251. (This is a 24-hour
service).

What is tetanus?
Tetanus is a painful disease that affects the muscles and can cause breathing problems. In
some situations, it can cause death. It is caused when germs that are found in soil and manure
get into the body through open cuts or burns.

Is tetanus a fatal disease?

Tetanus is rare in the UK because of the effectiveness of the immunisation programme; however, the
bacteria that causes the disease are always present in soil. They cannot be eradicated from our
environment. Consequently, anyone who is not fully protected against tetanus is at risk from the
disease, which if it is not treated, can kill.

What is tetanus immunoglobulin?

Tetanus immunoglobulin is a solution that contains antibodies which provides immediate protection
against tetanus. It is given as a protective measure, to stop people from getting tetanus or as a
treatment for cases of tetanus.

How is tetanus immunoglobulin different from tetanus vaccine?

The difference between tetanus vaccine and immunoglobulin is that the vaccine produces an immune
response that allows the recipient to make their own antibodies. It takes several months for protective
antibodies to be generated if you have never been vaccinated, and up to a week if you have been
vaccinated in the past. Tetanus immunoglobulin provides immediate protection against tetanus, but
the protection is only temporary because the body gradually loses the antibodies in tetanus
immunoglobulin naturally and does not make its own antibodies.
 © What is tetanus immunoglobulin used for?
Tetanus immunoglobulin is recommended when an individual has a tetanus prone wound and is not
up to date with their vaccinations. It is recommended in this case as it provides immediate protection.
Individuals will also be given a dose of vaccine, as their vaccinations are incomplete, to protect them
in the future.

Tetanus immunoglobulin may also be recommended for individuals who are fully vaccinated but who
have a tetanus prone wound which is also heavily contaminated i.e. a wound contaminated with
manure/soil or an abscess in an injection site. In a highly contaminated wound, toxin production can
outpace the capacity of the individual to produce their own antibodies to neutralise the toxins, thus
additional ‘immediate’ antibodies are required.

What should hospitals do for non-emergency cases during the shortage and is this
treatment as effective?
The Department of Health recommends the use of combined tetanus, low dose diphtheria and
polio vaccine (Revaxis), (or the equivalent age appropriate vaccine for young children). This should
be used where tetanus immunoglobulin would normally have been indicated, although this may not
generate a response quickly enough to prevent tetanus at the beginning of the incubation period.

If preferred, hospitals can import tetanus immunoglobulin on the basis of a Clinical Emergency
after the approval by the Medicines and Healthcare products Regulatory Agency.

Where do hospitals get their supplies of Revaxis from?

Supplies of Revaxis for this use should be obtained direct from the manufacturer, Sanofi Pasteur, or
place an order direct with hospital branches of AAH, Unichem and Mawdsley Brooks.

How many people get tetanus each year?

Over the last ten years, the number of cases of tetanus in the general population has been low,
with less than ten cases each year.

Before 2003 tetanus generally occurred in older unvaccinated people. Since July 2003 however
cases of tetanus have been occurring in injecting drug users, either due to contaminated drugs or to
contaminated sites of injection and abscesses. Eight cases were officially notified in 2003, 12 in
2004 and 3 in 2005; some additional cases are known to have occurred but were not reported to the
relevant authorities.