TRIVAX-AD

EVANS MEDICAL Adsorbed Diphtheria, Tetanus and Pertussis Vaccine, BP (Trivax-AD) (DT Per/Vac/Ads)

TRIVAX-AD is a sterile preparation consisting of a mixture of diphtheria and tetanus toxoids and killed whole Bordetella pertussis.

Each 0.5m1 of vaccine has an immunising potency of not less than 30 International Units (IU) purified diphtheria toxoid and not less than 60 IU (mouse assay) purified tetanus toxoid, with not more than 20,000 million chemically killed Bordetella pertussis organisms with a potency of not less than 4 IU adsorbed onto aluminium hydroxide in an isotonic buffer solution. The aluminium content does not exceed 1.25mg per dose. Organisms bearing all three pertussis agglutinogens are included. Vaccine of this composition has been shown to provide adequate immunising potency against each of the three diseases. Thiomersal is added as a preservative to a final concentration of 0.01% w/v. The vaccine also contains Sodium Borate, Succinic Acid, Sodium Chloride and Water for Injections.

The vaccine conforms to the requirements of the British Pharmacopoeia, the European Pharmacopoeia and the World Health Organisation.

Uses:

TRIVAX-AD is indicated for active immunisation against diphtheria, tetanus and whooping cough in infants and children under 6 years of age.

It is not recommended that pertussis-containing vaccines be used in older children except in areas where whooping cough s a serious problem.

Dosage and administration:

Adults and elderly: Not recommended.

Children up to 6 years: Each dose is 0.5ml. given by deep subcutaneous or intramuscular injection. The primary course consists of 3 doses of vaccine at intervals of not less than four weeks.

Since whooping cough can often be a serious disease in babies, the primary course should preferably be started in the early months of life. 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 triple 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 of 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 the 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 of age, between 4.5-5 months and 9-11 months of age.

Available data comparing antibody levels of diphtheria, pertussis and tetanus one year after the third dose indicate adequate levels of antibodies following either accelerated or extended schedules.

A single dose of TRIVAX-AD is recommenaed as the initial dose of a primary pertussis vaccination course for children aged 4 to 6 years who also require simultaneous reinforcement of immunity to diphtheria and tetanus. Vaccination against pertussis should be completed using monovalent pertussis vaccine.

Reinforcing doses: Where primary immunisation was completed during the first six to eight months of life one reinforcing dose of 0.5ml Adsorbed Diphtheria and Tetanus Vaccine (DT/Vac/Ads) should be given about 12 months later in order to boost immunity.

Children who have received diphtheria/tetanus/ pertussis vaccine (DTPer/Vac or DTPer/Vac/Ads) in an extended primary course (intervals 6 to 8 weeks and 4 to 6 months) do not require further immunisation against pertussis. Reinforcement of immunity against diphtheria and tetanus is necessary. This can be achieved by giving one dose (0.5ml) Adsorbed Diphtheria and Tetanus Vaccine (DT/Vac/Ads) to children before school entry or during the first year at school (up to 6 years) and one dose (0.5m1) of adsorbed or plain Tetanus Vaccine (Tet/Vac/Ads or Tet/Vac/FT) at 15 to 19 years of age or on leaving school. Shake well before withdrawing a dose. It is good practice to record the title, dose and lot numbers of all vaccines and dates of administration. Any untoward reactions should be reported to the regulatory authorities and to the manufacturer.

Contra–indications and warnings

Contra -indications: Not for intradermal use. The administration of pertussis-containing vaccine is contra-indicated in children with a personal, or family history in parents or siblings of idiopathic epilepsy or other familial or hereditary diseases of the central nervous system. Administration of pertussis vaccine is also contra-indicated in children with a history of seizures, convulsions, cerebral irritation in the neonatal period, developmental neurological defect or other disorder of the central nervous system.

Children with acute infection or illness, particularly those with respiratory symptoms, should not be immunised until they are fully recovered. Any child exhibiting a severe local or significant general reaction to a previous dose of a pertussis-containing vaccine should not be given a further dose. However, protection against diptheria and tetanus is advisable and can be accomplished by giving Adsorbed Diphtheria and Tetanus Vaccine (DT/VAC/Ads).

Precautions: Since combined diphtheria, tetanus and pertussis vaccines are widely used in a population in which sudden illnesses of undefined origin are not uncommon, concurrent illness bearing a temporal but not a causal relationship to vaccination may be expected.

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

Side and adverse effects Local reactions, particularly erythema at the site of injection, are commonly seen during the 24 hours following vaccination. They normally subside without treatment. A nodule may be found at the site of injection, especially if the inoculation is introduced into the superficial levels of subcutaneous tissue: this occurs less frequently and is less persistent following the administration of plain vaccine.

A transient rise in temperature, restlessness, irritability, crying or loss of appetite may sometimes occur a few hours after vaccination, but does not generally call for treatment. Systemic reactions such as headache, malaise and somnolence have been reported. The incidence of these systemic reactions is lower following the administration of adsorbed vaccine. Allergic manifestations including pallor, dyspnoea and collapse nave been observed rarely. Neurological events have occasionally been observed following the administration of pertussis-containing vaccines. The events reported do not appear to constitute a single, identifiable clinical syndrome but include isolated febrile convulsions, infantile spasms, episodes of persistent screaming and severe encephalopathy resulting in permanent brain damage or death. These events cannot be distinguished from those occurring in unvaccinated children of similar age. In the absence of a common, identifiable pathological mechanism, it is not possible to produce reliable estimates of the incidence of neurological events attributable to pertussis vaccination per Se.

An increased incidence of reactions may occur due to failure to shake the container and re-suspend the vaccine before withdrawing a dose, to inadvertent intravenous administration, or to an over-rapid injection.

Studies undertaken to monitor adverse events associated with the accelerated schedule have shown that there are fewer adverse events when compared to the extended schedules

Use in pregnancy and lactation: Since simultaneous vaccination against diphtheria, tetanus and pertussis in adults is uncommon there is no accurate information on the safety of this vaccine in pregnancy.

Store upright between 2 and 8°C protected from light. Vaccine which has been frozen should not be used. When multi-dose containers are employed, t is good practice to discard any partly used vaccine vials at the end of the vaccination session.

Disposal should be by incineration at a temperature not less than 1100°C at a registered waste disposal contractor.

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

Legal catagory POM

Package Quantities: Pack of 5 x O.5m1 ampoules. Pack of 1 x 0.5m1 ampoule. Vial of 5ml.

Product licence number 0039/0474

Manufacturer: The Wellcome Foundation Limited, London NW1 2BP

Licence holder: Evans Medical Limited, Leatherhead, England

Preparation date: July 1994

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