Hepatitis b vaccine

Intramuscular
Active immunisation against hepatitis B
Adult: Primary immunisation: As recombinant HBsAg vaccine 18-19 years 10 mcg/0.5 mL for 3 doses given at 0, 1, and 6 months; ≥20 years 20 mcg/mL for 3 doses given at 0, 1, and 6 months. An accelerated immunisation schedule given at 0, 1, 2, and 12 months may be followed. As recombinant, adjuvanted HBsAg vaccine: 20 mcg/0.5 mL for 2 doses given at least 1 month apart. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).
Child: Primary immunisation: Recombinant HBsAg vaccine: Infants HBsAg-negative mothers: 1st dose: 10 mcg/0.5 mL within 24 hours of birth; 2nd dose: 1-2 months of age; 3rd dose: 6-18 months of age; Birthweight <2 kg: Initial dose at 30 days of chronological age or at hospital discharge (whichever is 1st). HBsAg-positive mothers: 1st dose: 10 mcg/0.5 mL within 1st 12 hours of life, with HBIG at separate inj site; 2nd dose: Birthweight <2 kg: 10 mcg/0.5 mL at 1 month of age; ≥2 kg: 10 mcg/0.5 mL at 1-2 months of age; 3rd dose: Birthweight <2 kg: 10 mcg/0.5 mL at 2-3 months of age; ≥2 kg: 10 mcg/0.5 mL at 6 months of age; 4th dose: Birthweight <2 kg: 10 mcg/0.5 mL at least 6 months of age (24 weeks). Unknown HBsAg status: Follow vaccination schedule of those born to HBsAg-positive mothers, then once maternal status is determined follow the applicable vaccination schedule. ≤17 years 10 mcg/0.5 mL for 3 dose at 0, 1, and 6 months.
Renal impairment: As recombinant HBsAg vaccine: Haemodialysis patient: 40 mcg/2 mL given at 0, 1, 2, and 6 months. Dosage and vaccination schedule recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).

Hypersensitivity.

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).

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.

Diminished therapeutic effect with immunosuppressants. Increased risk of bleeding with anticoagulants.

Hepatitis B vaccine is a noninfectious viral vaccine which induces formation of anti-hepatitis B antibodies, leading to active immunity against hepatitis B virus (HBV) infection.

Intramuscular: Store between 2-8°C. Do not freeze. Storage recommendations may vary according to individual products and between countries (refer to specific product or official country guidelines).

Vaccines, Antisera & Immunologicals