Contraindications
Hypersensitivity.
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Special Precautions
Patient with bleeding disorders (including thrombocytopenia), multiple sclerosis. Immunocompromised patients (e.g. patients receiving chemotherapy, radiation, or immunosuppressant therapy). This vaccine may be available in multiple formulations which may contain different HBsAg concentrations; certain formulations may be specifically used only for neonates, children, or adults, refer to specific product guidelines prior to administration. Defer vaccine administration in patients with moderate or severe acute illness (with or without fever). Renal impairment. Neonates, children, and elderly. Pregnancy and lactation. Monitoring Parameters Assess for signs of anaphylaxis and syncope for 15 minutes after administration. May consider monitoring of respiratory function for 48-72 hours after administration in preterm infants. Perform serologic testing for those patients who may be at risk of not achieving seroprotection after a complete course of the vaccine (refer to specific product or local country guidelines).
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Adverse Reactions
Significant: Shoulder injury (e.g. shoulder bursitis or tendinopathy) due to vaccine administration; syncope, bleeding or haematoma (in patients with bleeding disorders); exacerbation of multiple sclerosis, anaphylactoid and/or hypersensitivity reactions; apnoea (particularly in premature infants).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Inj site pain, redness, swelling and induration; fever, malaise.
Metabolism and nutrition disorders: Appetite loss.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache, drowsiness, dizziness.
Psychiatric disorders: Irritability, insomnia, nervousness.
Skin and subcutaneous tissue disorders: Rash.
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Drug Interactions
Diminished therapeutic effect with immunosuppressants. Increased risk of bleeding with anticoagulants.
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CIMS Class
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