Data Sheet

DIPHTHERIA VACCINE, CHILD (ADSORBED)

For the active immunization of children against diphtheria

This vaccine contains purified diphtheria toxoid adsorbed on to a mineral carrier, aluminium phosphate. Thiomersal 0.01% w/v is added as a preservative.

Before issue, each batch of vaccine is tested for potency, safety and sterility, and conforms to the requirements of the British Pharmacopoeia.

Indications for Use

The use of this product should be confined to persons above two months and below eight years of age. Experience has shown that severe hypersensitivity reactions are likely to occur if this product is given to older children and adults.

For the active immunization of persons eight years of age and over, the following Adult vaccines, containing a reduced concentration of diphtheria toxoid, are available.

• Diphtheria Vaccine, Adsorbed (Diluted for Adult Use),
• ADT^® Vaccine [Diphtheria and Tetanus Vaccine, Adsorbed (Diluted for Adult Use) for simultaneous immunization against diphtheria and tetanus (see separate leaflets).

Dosage and Administration

Injections should be given intramuscularly into alternate limbs.

Primary Immunisation

Three doses, each of 0.5 mL, should be given at an interval of 6 to 12 weeks between the first two doses and 6 to 12 months between the second and third.

Booster Immunisation

All children who have been immunised against diphtheria in infancy or early childhood should be given a single booster dose of 0.5 mL on entering school (4 to 5 years of age) or at any time up to the age of eight years. If the child has also been immunised previously with tetanus toxoid and is due for a tetanus booster as well, CDT™ Vaccine should be used.

For routine boosting of immunity to diphtheria and tetanus, CDT™ Vaccine should be used up to the age of eight years, and ADT^® Vaccine thereafter.

For routine boosting of immunity to diphtheria only, after the age of eight years, Diphtheria Vaccine, Adsorbed (Diluted for Adult Use) should be used.

Side Effects

Some transitory redness and swelling may occur at the site of injection. A small lump, due to the slowly absorbed mineral carrier may be felt in the subcutaneous tissue for some weeks, especially if the injection is given too superficially.

General reactions are very uncommon.

Precaution

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.

The container should be thoroughly shaken before use until even dispersion of the toxoid is obtained.

Mode of Issue

Diphtheria Vaccine, Adsorbed is issued in 0.5 mL containers.

Storage

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

Medicine Classification

Prescription Medicine.

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

ADT^® is a Registered Trademark of CSL Limited

CDT™ is a Trademark of CSL Limited