Hiberix Caution For Usage

Incompatibilities: Hiberix can be mixed in the same syringe with GlaxoSmithKline vaccines Infanrix (DTPa vaccine), or Tritanrix HB (DTPw-HB vaccine). Other injectable vaccines should always be administered at different injection sites.
Hiberix should not be mixed with other vaccines in the same syringe (except for authorised combinations).
Instructions for Use/Handling: How to use Hiberix: The solvent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance prior to reconstitution or administration. If either is observed, do not use the solvent or the reconstituted vaccine.
Instructions for reconstitution of the vaccine with solvent presented in vials (US manufactured) or ampoules: Hiberix must be reconstituted by adding the entire contents of the supplied container of solvent to the vial containing the powder. The mixture should be well shaken until the powder is completely dissolved in the solvent.
The reconstituted vaccine is a clear to opalescent and colourless solution.
When using a multidose vial, each dose should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
After reconstitution, the vaccine should be used promptly.
Withdraw the entire contents of the vial.
A new needle should be used to administer the vaccine.
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe: Hiberix must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
To attach the needle to the syringe, carefully read the instructions given. However, the syringe provided with Hiberix might be slightly different than the syringe described.
Always hold the syringe by the barrel, not by the syringe plunger or the Luer Lock Adaptor (LLA), and maintain the needle in the axis of the syringe. Failure to do this may cause the LLA to become distorted and leak.
During assembly of the syringe, if the LLA comes off, a new vaccine dose (new syringe and vial) should be used.
1. Unscrew the syringe cap by twisting it anticlockwise.
2. Attach the needle to the syringe by gently connecting the needle hub into the LLA and rotate a quarter turn clockwise until it locks.
3. Remove the needle protector, which may be stiff.
4. Add the solvent to the powder. The mixture should be well shaken until the powder is completely dissolved in the solvent.
The reconstituted vaccine is a clear to opalescent and colourless solution.
After reconstitution, the vaccine should be used promptly.
5. Withdraw the entire contents of the vial.
6. A new needle should be used to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle by repeating step 2.
To mix Hiberix with Tritanrix HB or Infanrix: Hiberix vaccine may be reconstituted either with Tritanrix HB or with Infanrix for simultaneous administration via one injection. Make sure the container of the vaccine intended for mixing with Hiberix is a monodose container.
Tritanrix HB and Infanrix are presented as suspensions. Upon storage, a white deposit and clear supernatant may be observed. The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, do not use the vaccine.
From the Hiberix package, discard the container containing the sterile solvent.
The combined DTPw-HB-Hib or DTPa-Hib vaccines must be reconstituted by adding the entire contents of either a Tritanrix HB or Infanrix monodose container to the monodose vial containing the white Hiberix powder. After the addition of Tritanrix HB or Infanrix to the Hiberix powder, the mixture should be well shaken until the Hiberix powder is completely dissolved in either the Tritanrix HB or Infanrix suspension.
The extemporaneously combined vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, do not use the reconstituted vaccine.
After reconstitution, the vaccine should be used promptly.
Withdraw the entire contents of the vial.
A new needle should be used to administer the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.