INFORMATION FOR HEALTH PROFESSIONALS
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ADT™ Vaccine is a suspension of aluminium-phosphate-adsorbed diphtheria and tetanus toxoids.
Each 0.5mL dose contains no less than 2 International Units (IU) of purified diphtheria toxoid and no less than 20 IU of purified tetanus toxoid. Thiomersal 0.01% w/v is added as a preservative.
Each dose of ADT™ Vaccine also contains the following excipients: aluminium phosphate adjuvant (3.0mg), sodium chloride (4.3mg), sodium phosphate - monobasic (59.5(g), sodium phosphate dibasic (575(g), thiomersal (50(g) and Water for Injections.
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.
Following intramuscular injection, ADT™ Vaccine stimulates production of antibodies that protect against the diseases caused by exposure to Corynebacterium diphtheriae and Clostridium tetani.
ADT™ Vaccine is recommended for adults and children over 8 years of age, for the simultaneous immunisation against diphtheria and tetanus.
In accordance with Australian NHMRC* and New Zealand immunisation guidelines, ADT™ Vaccine is recommended for booster immunisation against diphtheria and tetanus for children and adults who have previously received primary immunisation (3 doses of DTP, DTPa or DTPa-combination vaccine).
ADT™ Vaccine may also be used in those aged 8 years and older who do not have a documented history of a primary vaccination for diphtheria and tetanus.
Individuals who have received a primary course of 3 doses of a tetanus toxoid containing vaccine as adults, should receive booster doses of ADT™ Vaccine 10 and 20 years after the primary course.
All adults who reach the age of 50 without having received a boosting dose of ADT™ Vaccine in the previous 5 years should receive a further boosting dose.
A booster dose of ADT™ Vaccine may also be used in the event of a tetanus-prone injury (see also PRECAUTIONS).
The Vaccine should not be administered to subjects who have previously experienced a serious reaction (e.g. anaphylaxis) to this vaccine or who are known to be hypersensitive to any of the vaccine components.
As with other injectable vaccines, appropriate medical treatment and supervision should always be available in the event of anaphylactic reaction. Adrenaline should always be readily available whenever the injection is given.
Individuals who sustain an injury likely to favour growth of tetanus microorganisms, and to whom diphtheria vaccines are contraindicated, should be given a booster dose of tetanus toxoid vaccine, adsorbed except in the following instances:
Occasionally, persons become sensitised to the tetanus toxoid component of the vaccine as a result of previous administration. In such cases it would be advisable to administer a fractional dose of Tetanus Vaccine, Adsorbed (0.1 mL) under oral antihistamine cover.
Note: if more than 10 years have elapsed since the last booster dose of diphtheria toxoid, then ADT™ Vaccine should be used in place of a tetanus containing vaccine, as a wound booster.
If there is any doubt about the adequacy of prior tetanus immunisation, tetanus immunoglobulin should be given as well a tetanus toxoid.
No increase in frequency of malformations or other direct or indirect harmful effects on the foetus have been observed.
Following vaccination with ADT™ Vaccine, local reactions reported include injection site reaction (including pain, erythema, swelling, inflammation, pruritus and induration). These reactions can be minimised if care is taken to ensure that the injection is given deeply and that no vaccine material is deposited superficially or along the track of the needle.
Systemic reactions reported include pruritus, rash, urticaria and peripheral oedema, anaphylactoid and hypersensitivity reactions, flu-like symptoms (including headache, rigors, asthenia, fatigue, myalgia), pyrexia, nausea, vomiting and dizziness. Postvaccinal neurologic disorders have been reported following the injection of almost all biological products, and the possibility of their occurrence must be considered. Such disorders have included hypoaesthesia, paraesthesia and brachial radiculitis.
The dose of ADT™ Vaccine is 0.5 mL. Injections should be given by the intramuscular route, and alternate limbs should be used for successive injections.
Should ADT™ Vaccine be used for primary vaccination against diphtheria and tetanus, the recommended regimen is three doses of 0.5mL at intervals of 6 to 12 weeks between the first and second dose, and 6 to 12 months between the second and third dose.
ADT™ Vaccine is for single use in one patient only. Discard any residue.
The syringe should be thoroughly shaken before use to ensure adequate dispersion of the mineral carrier and the vaccine should be injected as soon as possible.
The ADT™ Vaccine 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.
ADT™ Vaccine is supplied in a 0.5mL pre-filled syringe, encased within a clear film wrapper.
ADT™ Vaccine should be protected from light and stored at 2°C to 8°C. It must not be frozen.
In Australia:
CSL Limited ABN 99 051 588 348
45 Poplar Road
Parkville VIC 3052 AUSTRALIA
In New Zealand:
CSL (New Zealand) Limited
PO Box 62590
Central Park, Auckland 6
NEW ZEALAND
Prescription Medicine
Date of last amendment: 21 September 2005
7 July 2005
* NHMRC - National Health and Medical Research Council publication "The Australian Immunisation Handbook 8th Edition 2003".
ADT™ is a Trademark of CSL Limited