Hiberix Dosage

​2.1 Dose and Schedule

​After reconstitution, a single dose of HIBERIX is either 0.5 mL or approximately 0.5 mL depending on the presentation [see Dosage and Administration (2.2​)]​.

​HIBERIX is administered as a 4-dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age, followed by a booster dose administered at 15 through 18 months of age. The first dose may be given as early as 6 weeks of age.

​2.2 Presentations and Reconstitution

​HIBERIX is supplied in 2 presentations as follows:

​Vial and Vial Presentation

​The vial and vial presentation includes a vial of Lyophilized Antigen Component and a vial of Sterile Saline Diluent.

​Vial and Prefilled Syringe Presentation

​The vial and prefilled syringe presentation includes a vial of Lyophilized Antigen Component and a prefilled syringe of Sterile Saline Diluent.

​For both presentations reconstitute the Lyophilized Antigen Component only with the accompanying Sterile Saline Diluent to form HIBERIX.

​Instructions for Vial and Vial Presentation

​Figure 1. Cleanse both vial stoppers. Using a graduated syringe, withdraw 0.6 mL of Sterile Saline Diluent from accompanying vial.	​Figure 2. Transfer 0.6 mL Sterile Saline Diluent into Lyophilized Antigen Component vial.	​Figure 3. Shake the vial well until the powder is completely dissolved.	​Figure 4. After reconstitution, withdraw 0.5 mL of reconstituted vaccine into the same syringe and administer intramuscularly.

​Instructions for Vial and Prefilled Syringe Presentation

​Figure 1. Hold the ungraduated prefilled syringe of Sterile Saline Diluent by the barrel and unscrew the syringe cap by twisting it counterclockwise. Align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock.	​Figure 2. Cleanse the Lyophilized Antigen Component vial stopper. Transfer the entire contents of the prefilled syringe into the vial.	​Figure 3. Shake the vial well until the powder is completely dissolved.	​Figure 4. After reconstitution, withdraw the entire contents of reconstituted vaccine into the same syringe and after changing the needle administer the vaccine intramuscularly.

​2.3 Administration

​The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

​Administer HIBERIX intramuscularly immediately after reconstitution.