japanese encephalitis vaccine (inactivated, adsorbed): clinical use

Prescribing considerations

• Base use on individual travel or occupational exposure risk; vaccination does not replace mosquito-bite prevention.
• Immune responses may be inadequate in immunodeficiency or during immunosuppressive treatment.
• Postpone administration during an acute severe febrile illness.
• Consider injection-route implications in thrombocytopenia, haemophilia or other bleeding disorders.
• Protection is not universal and does not extend to encephalitis caused by other organisms.

Contraindications and cautions

• Hypersensitivity to the active substance, an excipient or listed manufacturing residues, including protamine sulphate, formaldehyde, bovine serum albumin, host-cell material or sodium metabisulphite
• A hypersensitivity reaction following a previous administration

Monitoring

• Ensure immediate treatment and supervision are available for anaphylaxis.
• Record the product name and batch number for traceability.
• Check the suspension after shaking; do not use if discoloured, damaged or containing persistent particles.

Clinical pharmacology

An inactivated SA14-14-2 Japanese encephalitis virus vaccine produced in Vero cells and adsorbed onto hydrated aluminium hydroxide. Protection is associated with virus-neutralising antibodies; pharmacokinetic assessment is not applicable.

Formulation and product differences

• The product is a suspension in a single-use pre-filled syringe.
• The suspension separates during storage and must be shaken until white, opaque and homogeneous.
• Syringe preparation differs for children younger than 3 years and must follow the product instructions.
• The product is essentially sodium-free and potassium-free but may contain trace residual sodium metabisulphite.