Hiberix

Hiberix Caution For Usage

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Caution For Usage
Instructions for Use/Handling: 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 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.
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 the lock is felt.
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.
As stated in Incompatibilities as follows, Hiberix may be mixed with Infanrix monodose vaccine. In this case, the solvent supplied in the Hiberix package is replaced by the liquid Infanrix vaccine.
Make sure the container of the vaccine intended for mixing with Hiberix is a monodose container. From the Hiberix package, discard the container containing the solvent.
The combined vaccine must be reconstituted by adding the entire contents of the other vaccine container to the vial containing the Hib white powder.
This extemporaneously combined vaccine should be handled in the same way as the monocomponent reconstituted Hiberix vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Hiberix can be mixed in the same syringe with GlaxoSmithKline vaccine Infanrix (DTPa 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).
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