Data Sheet

CDT™ VACCINE

Diphtheria and Tetanus Vaccine, Adsorbed

For the active immunisation of infants and children under 8 years of age simultaneously against diphtheria and tetanus.

Composition

CDT™ Vaccine is a vaccine composed of a mixture of diphtheria toxoid and tetanus toxoid. Thiomersal 0.01% w/v is added as a preservative and aluminium phosphate is added as an adjuvant.

Each 0.5 mL dose has a potency of not less than 30 International Units (IU) of diphtheria toxoid and not less than 40 IU of tetanus toxoid.

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.

Actions

Following intramuscular administration, CDT™ Vaccine stimulates production of antibodies against each of the two infective organisms. Effective protection requires the administration of three injections of CDT™ Vaccine. Duration of immunity is believed to be long though it declines over a number of years and booster doses against diphtheria and tetanus are, therefore, considered desirable.

Indications for Use

CDT™ Vaccine is recommended for the simultaneous immunisation of children, between the ages of 2 months and 8 years, against diphtheria and tetanus. CDT™ Vaccine may be substituted for Triple Antigen™ in children under 2 years of age when a severe constitutional reaction has followed a dose of Triple Antigen. CDT™ Vaccine should be used to boost the immunity of children over the age of 2 years immunised primarily with Triple Antigen™.

NOTE: Adults and children 8 years of age and over requiring simultaneous primary or booster immunisation against diphtheria and tetanus should be given ADT^® Vaccine.

Contraindications

• Immunisation should not be carried out during the course of an acute illness.
• History of a severe local or systemic reaction to CDT™ Vaccine.

Precautions

• DO NOT administer by any route other than by deep intramuscular injection. Injections given subcutaneously are believed to increase the risk of local reactions.
• An accurate and detailed history must be sought about a child's reaction to a previous dose of CDT™ Vaccine.
• There should normally be an interval of at least one month between the administration of CDT™ Vaccine and a live vaccine (except Sabin vaccine).
• Caution, on an individual basis, should be exercised in cases with a history of allergy. Such a history is generally not considered to be a contraindication to childhood immunisation. (See CONTRAINDICATIONS)
• Containers should be shaken vigorously immediately before opening and the vaccine should be injected as soon as possible after the syringe is filled.
• When using multi-dose containers a new single dose syringe should be used for each person in order to avoid transmission of infection.
• Partially used multi-dose containers should be discarded at the end of the immunisation session.
• In immunosuppressed patients, antibody responses may be diminished.
• Appropriate medical advice should be obtained prior to routine immunisation of infants with stable neurological disease or family history of neurological disorders (other than due to trauma or infection).
• 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.

Side Effects

Local reactions may occur in about a third of vaccine recipients. Transitory redness and swelling are commonly observed. A small lump, due to the slowly adsorbed mineral carrier, may be felt in the subcutaneous tissues for some weeks; this is more likely to happen if the injection is given too superficially.

General reactions have been noted in 10% of infants receiving CDT™ Vaccine. These are usually mild and transitory. The commonest reported reactions are irritability, malaise and fever. Serious and persisting reactions are extremely rare.

Dosage and Administration

The dose of CDT™ Vaccine is 0.5 mL. Injections should be given by the deep intramuscular route, and alternate limbs should be used for successive injections.

The recommended primary, or basic course consists of three doses of 0.5 mL at intervals of 6 to 12 weeks between the 1st and 2nd doses and 6 to 12 months between the 2nd and 3rd doses. Active immunity against diphtheria and tetanus should be maintained by giving a dose of CDT™ Vaccine at school entry, followed by doses of ADT^® Vaccine at intervals of approximately ten years.

Individuals who sustain an injury likely to result in tetanus should be given a wound booster dose of Tetanus Vaccine, Adsorbed except in the following instances:

1. the injury has occurred less than 2 years after completion of the basic course of any of the standard vaccines which contain tetanus toxoid (i.e. Triple Antigen™, CDT™ Vaccine, ADT^® Vaccine or Tetanus Vaccine, Adsorbed), or
2. the injury has occurred within 5 years of a booster dose of any of these vaccines.

NOTE: If over 10 years have elapsed since the last booster dose of diphtheria toxoid, then ADT^® Vaccine should be substituted for Tetanus Vaccine, Absorbed as a wound booster.

Record of Immunisation

The parent or guardian of any child immunised with CDT™ Vaccine should be given a written statement recording the details of immunisation.

Method of Administration

There is some suggestion in the literature that the injection technique may contribute to the severity of local reactions, including abscess formation at the injection site, as a result of the antigen seeding the needle track. The following precautions have been suggested:

(a) When withdrawing the antigen into the syringe avoid any residue on the outer surface of the needle.

(b) Administer by deep intramuscular injection.

(c) Inject slowly so as to allow the injected material to disperse instead of coming up the needle track.

Presentation

CDT™ Vaccine is issued in 0.5 mL and 5 mL containers.

Storage

Store, protected from light, at 2° to 8° C. Do not freeze.

Medicine Classification

Prescription Medicine.

Reference

Feery, Brian J. Incidence and type of reactions to triple antigen (DTP) and DT (CDT) vaccines. Med J Aust 1982; 2:511-5.

Name and Address

Distributed by:

CSL (New Zealand) Limited
Level 4, Building 10
Central Park
666 Great South Road
Auckland
NEW ZEALAND

Telephone: 09 579 8105

Manufactured by:

CSL Limited ACN 051 588 348
45 Poplar Road
Parkville 3052 VICTORIA AUSTRALIA

Date of Preparation

25 June 1999

CDT™ and Triple Antigen™ are Trademarks of CSL Limited.

ADT^® is a Registered Trademark of CSL Limited.