Contraindications
Hypersensitivity (when used for pre-exposure prophylaxis).
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Special Precautions
Patient with history of bleeding disorders (e.g. thrombocytopenia, haemophilia) and those receiving anticoagulant therapy. Immunocompromised patients (e.g. patients receiving chemotherapy or radiation therapy, including high-dose corticosteroids). Consider to defer vaccination during periods of severe immunosuppression. Delay pre-exposure prophylaxis in patients with febrile illness until the fever has resolved. Not for use in patients with a confirmed diagnosis of rabies. Premature infants and children. Pregnancy and lactation. Monitoring Parameters Monitor for anaphylaxis and syncope for at least 15 minutes after administration. Consider respiratory monitoring when giving primary immunisation series in very premature infants (≤28 weeks gestation) and those with history of respiratory immaturity. Perform serologic testing to detect the presence of rabies virus-neutralising antibodies in high-risk patients, including immunocompromised patients (refer to specific product or local country guidelines).
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Adverse Reactions
Significant: Hypersensitivity reactions, including anaphylaxis; serum sickness, syncope; apnoea (particularly in premature infants); meningitis, neuroparalytic events (e.g. encephalitis, transient paralysis), retrobulbar neuritis, multiple sclerosis. Rarely, Guillain-Barre syndrome.
Blood and lymphatic system disorders: Lymphadenopathy.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Inj site pain, erythema, swelling/induration, pruritus, and haematoma; malaise, fever, fatigue, asthenia, chills, influenza-like symptoms.
Immune system disorders: Angioedema.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Dizziness, headache, somnolence, paraesthesia, convulsion.
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Drug Interactions
Diminished efficacy with radiation therapy, antimalarials, corticosteroids, and other immunosuppressive agents. Increased risk of bleeding or haematoma with anticoagulants.
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CIMS Class
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