DIFTAVAX:

Adsorbed Diphtheria and Tetanus Vaccine for Adults and Adolescents BP.  Pasteur Merieux.

 Presentation:

Sterile aqueous suspension containing purified tetanus and low dose diphtheria toxoids. Each 0.5 ml dose contains not less than 40lU of tetanus toxoid and not less than 4lU of diphtheria toxoid. The toxoids are adsorbed onto aluminium hydroxide; thiomersal is added as preservative.

Indications:

Active immunisation against tetanus and diphtheria for persons over ten years.

Dosage and Administration:

By deep subcutaneous or intramuscular injection.

Primary Immunisation:

Three injections each of 0.5 ml. with an interval of at least 4 weeks between the first and the second doses, and at least 4 weeks between the second and third doses. If a course is interrupted it may be resumed: there is no need to recommence a primary course.

Reinforcing Doses:

A reinforcing dose of 0.5 ml is recommended after 10 years.

Use in Children:

Adsorbed Diphtheria and Tetanus Vaccine for Adults and Adolescents BP would not normally be administered to children under 10 years. Children under this age may receive Adsorbed Diphtheria and Tetanus Vaccine BP (DT/Vac/Ads) which contains a higher amount of diphtheria toxoid.

Use in Elderly:

No special comment.

Contra-indications:

Acute infectious illness. Severe reaction to a previous dose, or known hypersensitivity to any component of the vaccine. lmmunisation with either diphtheria or tetanus toxoid within the preceeding month.

Precautions:

Adults and adolescents over 10 years requiring combined diphtheria and tetanus immunisation must always receive vaccine containing low dose diphtheria (not less than 4lU).

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

Warnings:

Not for intradermal injection.

Schick testing is not necessary prior to immunisatuon.

Primary immunisatuon should only be considered for adults and adolescents who have not received a primary DTP or DT immunisation series in childhood.

Routine reinforcing doses at intervals of less than 10 years are not normally indicated and may be associated with an increased incidence and severity of reactions.

When diphtheria immunisation is indicated for subjects immunised against tetanus within the previous 10 years. the benefits of immunisation should be assessed against the possible risk of reactions.

Adsorbed Diphtheria and Tetanus Vaccine for Adults and Adolescents BP may normally be given to subjects requiring tetanus toxoid for wound management, to help ensure continuing diphtheria immunity, unless they have received a diphtheria toxoid containing vaccine in the last 10 years.

Adverse Reactions:

Local reactions such as transient erythema, swelling, tenderness or pain at the injection site or rarely systemic effects such as fever, headache, malaise and pallor may occur. Acute allergic reactions have been reported after administration of adsorbed diphtheria and tetanus vaccines, including dyspnoea, urticaria, angioneurotic oedema, peripheral neuropathy and rarely, anaphylaxis. A persistent nodule at the site of vaccination may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue.

Use in Pregnancy and Lactation:

No reproductive studies have been conducted in animals. There are no data on the use of thus vaccine in pregnancy or lactation. The vaccine should not normally be used in pregnancy or during lactation unless the benefit outweighs the risk.

Pharmaceutical Precautions:

Store at +2°C to +8°C.

Do not freeze.

Shake before use.

Legal Category

POM.

Package Quantities:

0.5 ml single dose pre-filled syringe unit pack

Product licence number  PL6745/0055 POM

1995

Pasteur Merieux MSD. Berkshire SL6 7BU. Tel  01628 785291

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