Genvac-B Dosage/Direction for Use

Pediatric dose vaccine: 10 mcg dose (in 0.5 mL suspension) is recommended for neonates, infants, children and adolescents up to 19 years of age.
Adult dose vaccine: 20 mcg dose (1.0 mL suspension) is recommended for adults aged 20 years and above.
Immunisation Schedule: Primary Immunisation: A series of three intramuscular injections is required to achieve optimal protection.
The following immunisation schedules can be recommended: 6, 10, 14 weeks for infants; 0, 1, 6 months; 0, 1, 2 months (rapid schedule).
The immunisation schedule should be adapted to meet local immunisation recommendations.
Booster Dose: The need for the booster dose in healthy individuals who have received the full primary immunization, is not recommended. It would seem advisable to recommend a booster dose when Anti-HBs antibody titres fall below 10 IU/L for all people at risk and especially for patients who are immunocompromised (HIV infected patients) or those on haemodialysis.
Special Dosage Recommendations: Dosage Recommendation for Neonates Born of Mothers who are HBV Carriers: The 0, 1, 2 month immunisation schedule is recommended, and should start at birth. Concomitant administration of Hepatitis B immunoglobulin not necessary, but when Hepatitis B immunoglobulin is given simultaneously with GENVAC-B a separate injection site must be chosen.
Dosage Recommendation for Known or Presumed Exposure of HBV: In circumstances where exposure to HBV has recently occurred (e.g. needle stick with contaminated needle) the first dose of GENVAC-B can be administered simultaneously with Hepatitis B immunoglobulin which however must be given at a separate injection site. The rapid immunisation schedule should be advised.
Dosage Recommendation for Immunocompromised Persons: The primary immunisation schedule for chronic haemodialysis patients or persons who have an impaired immune system is four doses of 40 mcg at 0, 1, 2 and 6 months from the date of first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains above the accepted protective level of 10 IU/L.
Immune Deficiency: Individuals infected with human immuno-deficiency virus (HIV), both asymptomatic and symptomatic, should be immunized with Hepatitis B vaccine according to standard schedules.
Method of Administration: GENVAC-B should be injected intramuscularly in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. The vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. The vaccine should be well shaken before use. Only sterile needle and syringes should be used for each injection. Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of Hepatitis B from which one or more doses of vaccine have been removed during an immunisation session may be used in subsequent immunisation sessions for up to a maximum of 28 days, provided that all of the following conditions are met (as described in the WHO policy statement: Handling of multi dose vaccine vials after opening, WHO/IVB/14.07): The vaccine is currently prequalified by WHO; The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO; The expiry date of the vaccine has not passed; The vaccine vial has been, and will continue to be, stored at WHO or manufacturer recommended temperatures; furthermore, the vaccine vial monitor, if one is attached, is visible on the vaccine label and is not past its discard point, and the vaccine has not been damaged by freezing.
The vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In event of either being observed, discard the vaccine.