INFORMATION FOR HEALTH PROFESSIONALS
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For active immunization against tetanus
Each 0.5mL dose of the vaccine has a potency of not less than 40 International Units (IU) of highly purified tetanus toxoid adsorbed to the mineral carrier aluminium phosphate. The aluminium salt has an adjuvant effect, thereby increasing the level and duration of the immunity afforded by the toxoid. Tet-Tox™ conforms to all requirements of the British Pharmacopoeia relating to potency, safety and sterility. Thiomersal 0.01% w/v is added as a preservative.
The potency of this vaccine is now expressed in International Units in accordance with the Australian labelling requirements and the European Pharmacopoeia. These units measure the immunising activity of the vaccine, whereas the previously used Lf units, expressed the quantity of toxoid present. No change has been made to the potency, although the potency is now expressed in IU.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product.
Tet-Tox™ is indicated for the active immunisation against tetanus in adults and children two months of age or older when protection is desired specifically against tetanus.
Note
Prior systemic allergic reaction to Tetanus Toxoid.
An acute respiratory infection or other active infection is reason for deferring administration of routine primary immunising or recall (booster) doses, but not emergency wound recall (booster) doses. Prolonging the interval between primary immunising doses for six months or longer dose not interfere with the final immunity. Regard any dose of tetanus toxoid an individual has received, even a decade earlier, as an immunising injection.
The occurrence of any type of neurological symptoms or signs following administration absolutely contra-indicates further use.
Under no circumstances should tetanus toxoid be used to treat actual tetanus infections, or for immediate prophylaxis of unimmunised individuals. Tetanus Immunoglobulin (Human) is used for this purpose.
There is no convincing evidence of risk to the foetus from immunisation of pregnant women using tetanus toxoid.
Concomitant immunosuppressive therapy: Avoid or postpone tetanus toxoid in persons receiving effective immunosuppressive therapy. The use of toxoid in such cases or in agammaglobulinaemia may not initiate adequate antibody response.
Allergic reactions: Take every precaution to prevent and arrest allergic and other untoward reactions. A careful history should review possible sensitivity to the type of protein to be injected. As with other injectable vaccines, appropriate medical treatment and supervision should always be available in case of anaphylactic reactions. Adrenalin should always be readily available whenever the injection is given.
Only healthy individuals should be injected.
Avoid injecting vaccine into a blood vessel.
The syringe should be thoroughly shaken before use to ensure adequate dispersion of the mineral carrier and the injection should be administered as soon as possible.
Therapeutic doses of chloramphenicol may interfere with the response to tetanus toxoid. Concomitant administration of this antibiotic should be avoided.
Local Reactions: A small area of erythema, local redness and induration surrounding the injection site, persisting for a few days, is not unusual. A nodule may be palpable at the site of injection for a few weeks. These reactions can be minimised if care is taken to ensure that the injection is given deeply and that none of the toxoid is deposited superficially or along the track of the needle. Occasionally, the reaction may be due to persons having become sensitised to the toxoid as a result of previous administration. In these cases, it has been shown that adequate boosting of the tetanus antibody titre will occur with a dose of 0.1mL. An oral antihistamine may be given (2).
Facilities should be at hand in the event of a severe allergic reaction occurring. The majority of the extensive delayed type local responses have occurred in adults following booster doses and in children who have received several doses of tetanus toxoid in the past. The increasing incidence of extensive local reactions is one reason a ten year interval between routine booster doses is recommended. Arthus-type hypersensitivity reactions, characterised by severe local reactions (generally starting 2 to 8 hours after injection), may occur, particularly in those who have received multiple prior boosters. Although their cause is unknown, hypersensitivity to the toxin or bacillary protein of the tetanus organism itself is assumed to be a possibility in some; in others, interaction between the injected antigen and high levels of pre-existing tetanus antibody (antitoxin) from prior booster doses seems to be the most likely cause of the Arthus-type response.
General reactions are very uncommon after injections of tetanus toxoid.
Postvaccinal neurologic disorders have been reported following the injection of almost all biological products, and the possibility of their occurrence must be considered.
To establish active immunity a full course of three injections of Tet-Tox™ must be given. Two basic doses of 0.5 mL vaccine are administered by intramuscular injection at an interval of 6 to 12 weeks. Immunity conferred by these two doses lasts for about 12 months. The third (reinforcing) dose of 0.5 mL is given 6 to 12 months after the second dose. This will ensure a sound and durable immunity. The course need not be recommended if either of these intervals has been exceeded. ADT® Vaccine should be substituted for Tet-Tox™ where simultaneous primary immunisation against diphtheria and tetanus is required in persons over 8 years of age.
Every opportunity should be taken to institute the course of active immunisation in the unimmunised, for example, whenever a non-immune person presents with an injury. Even if it is considered necessary to provide immediate protection with Tetanus Immunoglobulin (Human), a dose of Tet-Tox™ should be given at the same time, but with a separate syringe and in the opposite limb. Arrangements should be made to have the full course of vaccine completed later.
Routine Booster: In order to maintain an adequate level of immunity throughout life, a dose of 0.5 mL should be given at approximately 10 year intervals in accordance with the NHMRC guidelines. If more than 10 but less than 20 years have elapsed, a single dose would be adequate for boosting purposes. If more than 20 years have elapsed, two doses separated by an interval of 4 to 6 weeks should be given to ensure adequate boosting. Where routine boosting against both diphtheria and tetanus is required. ADT® Vaccine should be substituted for Tet-Tox™.
Wound Boosters. An additional booster dose of 0.5 mL Tet-Tox™ should be given whenever a previously actively immunised person sustains a wound likely to support the growth of CI. tetani, unless there is reliable evidence that the injury occurred (a) less than 5 years after completion of the primary course of any of the standard vaccines containing tetanus toxoid (ADT®, or Tet-Tox™) or (b) within 5 years of a routine booster dose. If more than 20 years have elapsed since the last dose of vaccine containing tetanus toxoid, the wound booster should be followed by an additional dose of Tet-Tox™ 4 to 6 weeks later to ensure that durable immunity is restored. If more than 10 years have elapsed since the last dose of diphtheria toxoid, then ADT® Vaccine may be substituted as a wound booster.
In addition to Tet-Tox™, a prophylactic dose of tetanus antitoxin, i.e. 250 Units of Tetanus Immunoglobulin (Human), must be given to ensure immediate protection when a tetanus prone wound occurs in the following individuals:
RECORD OF IMMUNIZATION
Every patient immunised against tetanus should be given a written statement or card recording the details of immunisation.
Tet-Tox™ is supplied in a 0.5 mL pre-filled syringe and 0.5 mL ampoule (not marketed).
Tet-Tox™ is for single use in one patient only. Discard any residue.
The Tet-Tox™ syringe is supplied encased within a clear film wrapper. The presence of the film wrapper provides assurance that the product has not been opened. Do not use if the film wrap is damaged or missing.
Store, protected from light, at 2° to 8°C (Refrigerate. Do not freeze)
REFERENCES
Tet-Tox™, CDT™ and Triple Antigen™ are trademarks of CSL Limited.
ADT® is a Registered Trademark of CSL Limited.
Prescription Medicine.
CSL (New Zealand Ltd)
Level 9, Building 5
666 Great South Road
Penrose
AUCKLAND
Manufactured by:
CSL Limited ACN 051 588 348
45 Poplar Road
Parkville 3052
Victoria
AUSTRALIA
January 27, 2005