DT

Evans Medical

DATA SHEET      Adsorbed Diptheria & Tetanus Vaccine, BP (DT/Vac/Ads)

Presentation

Adsorbed Diphtheria and Tetanus Vaccine is a mixture of purified diphtheria and tetanus toxoids which are prepared by formalin detoxification of Corynebacterium diphtheriae and Clostridium tetani exotoxins. The toxoids are adsorbed onto Aluminium Hydroxide. The aluminium content does not exceed 1.25mg/dose. Thiomersal BP is added as a preservative to a concentration of 0.01 % w/v. The vaccine also contains Sodium Borate, Succinic Acid, Sodium Chloride and Water for Injections. Each 0.5ml dose contains not less than 30 IU diphtheria toxoid and not less than 40 IU tetanus toxoid. The vaccine conforms to the requirements of the World Health Organisation.

Uses

For active immunisation against diphtheria and tetanus.

Adsorbed Diphtheria and Tetanus Vaccine is used for the primary immunisation of infants and children under ten years of age against tetanus and diphtheria where the use of pertussis-containing vaccines TRIVAX or TRIVAX-AD (DTPer/Vac, DTPer/Vac/Ads) is contra-indicated or not required. It is also given to reinforce immunity in children under 10 years of age immunised in infancy with Diphtheria and Tetanus Vaccine, TRIVAX or TRIVAX-AD (DT/Vac/Ads, DTPer/Vac, DTPerNac/Ads).

For primary immunisation two or three intramuscular or deep subcutaneous injections separated by an interval of at least four weeks are recommended. Children under 10 years: Three doses of 0.5ml Adults, elderly and children over 10 years: Not recommended. In adults, elderly and children over 1 years of age, reinforcement of immunity to tetanus can be achieved by administering one dose of plain or Adsorbed Tetanus Vaccine (Tet/Vac/FT or Tet/Vac/Ads) and for diphtheria, the DoH currently recommend the use of Diphtheria Vaccine for adults (low dose).

Immunisation is a public health measure and recommended schedules are published by national health authorities. These take into account many parameters and may vary from country to country. In England, Wales and Eire, current recommendations indicate that the primary course for Adsorbed Diphtheria and Tetanus vaccine should start at 2 months of age, with an interval of one month between each dose. This accelerated schedule has been introduced to provide uniformity of dosing regimens, facilitate earlier protection and, by shortening intervals between immunisations, to enhance patient compliance.

The intervals between immunisations may be exceeded without need to repeat the full course immunisation. Indeed, it is believed that immune response is better, if the interval between the first and second dose is extended to six to eight weeks and the interval between the second and third dose to four to six months. Such intervals form the basis of the well established extended schedule for triple vaccine recommended by the manufacturer where primary vaccination is administered at 3 months age, between 4.5 - 5 months and 9 - 11 months age.

A reinforcing dose of 0.5m1 of adsorbed diphtheria and tetanus vaccines should be administered at about five years of age to children immunised in infancy with Diphtheria and Tetanus Vaccine or combined Diphtheria, Tetanus and Pertussis Vaccine (DT/Vac/Ads, DTPer/Vac/Ads, DTPer,Vac).

Poliomyelitis Vaccine (Oral) may be given at the same time as Diphtheria and Tetanus Vaccine. Shake thoroughly before withdrawing each dose. It is good practice to record the title, dose and lot numbers of all vaccines and the dates of administration. Any untoward reactions should b reported to the regulatory authorities and to the manufacturer.

Contra-indications, warnings etc

Adsorbed Diphtheria and Tetanus Vaccine should not be administered intradermally. Adsorbed Diphtheria and Tetanus Vaccine should not be administered to adults, elderly and children over 10 years of age.

The vaccine should not be administered to a subject who has experienced a serious reaction (eg anaphylaxis) to a previous dose of this vaccine or who is known to be hypersensitive to any component thereof. It is advisable to avoid vaccination during an acute infection.

Precautions: Although anaphylaxis is rare, facilities for its management should always be available during vaccination.

Side and adverse effects: Local reactions to diphtheria and tetanus vaccines are uncommon in young children. Local reactions consist of swelling, redness and tenderness at the injection site and may occasionally be severe.

General reactions consisting of transient fever, malaise and headache occur infrequently. Acute allergic reaction - anaphylaxis, urticaria, pallor, cyanosis and polyradiculoneuritis have been reported very rarely after diphtheria/tetanus vaccines.

Angioneurotic oedema, dyspnoea, serum sickness, peripheral neuropathy, neuropathy and polyneuritis have followed the administration of tetanus vaccine.

A small painless nodule may form at the injection site, but usually disappears without sequelae. Occasionally these nodules persist, especially if the inoculation is introduced into the superficial layers of subcutaneous tissue. Very rarely, circumscribed hypertrichosis and eczema are associated with such nodules.

Transverse myelitis has been reported after simultaneous administration of dipnthena and tetanus vaccine and oral polio vaccine, but a cause and effect relationship has not been established.

Use in pregnancy and lactation: Accurate information is not available on the safety of Adsorbed Diptheria and Tetanus Vaccine in pregnancy. The component toxoids have been available for use for many years without apparent ill-consequence.

No information on the immunisation of lactating women is available.

Pharmaceutical Precautions:

Store between 2 and 8C. Protect from light. Vaccine which has been frozen should not be used. It is good practice to discard any partly used vaccine vials at the end of the vaccinating session. Disposal should be by incineration at a temperature not less than 1100C at a registered waste disposal contractor.

DO NOT USE THIS VACCINE AFTER THE EXPIRY DATE ON THE LABEL

Legal Category: POM

Package Quantities: Pack of 5 x 0.5ml ampoules; vial of 5ml

Further In formation: Nil

Product Licence Number: 0039/0467

 

Product Licence Holder: Evans Medical Limited,  Leatherhead,

England.

Manufacturer: The Wellcome Foundation Limited, London, NW1 2BP

Preparation Date:September 1994