Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Vaccine : lactose
Diluent : sterile saline solution

6.2 Incompatibilities

Hiberix™ can be mixed in the same syringe with SmithKline Beecham vaccines Infanrix™ (DTPa vaccine), Tritanrix™ (DTPw 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).

6.3 Shelf-life

The expiry date of the vaccine is indicated on the label and packaging.
When stored under prescribed conditions, the shelf-life is 36 months.

6.4 Special precautions for storage

The lyophilised vaccine has to be stored at +2°C to +8°C. The lyophilised vaccine is not affected by freezing.

The diluent can be stored in the refrigerator or at ambient temperatures (up to 25°C) and should not be frozen.

6.5 Nature and content of container

The lyophilised vaccine is presented as a white pellet in a glass vial.
The sterile diluent (saline) is clear and colourless and presented in a prefilled syringe.

The vials and syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.

6.6 Instructions for us and handling, and disposal (if appropriate)

The diluent and reconstituted 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, discard the diluent or reconstituted vaccine.

The vaccine must be reconstituted by adding the entire contents of the supplied container of diluent to the vial containing the pellet. After the addition of the diluent to the pellet, the mixture should be well shaken until the pellet is completely dissolved in the diluent.

After reconstitution, the vaccine should be injected promptly.

As stated in section 6.2 above, Hiberix™ may be mixed with Infanrix™, Tritanrix™, Tritanrix™ HB monodose vaccines. In this case, the diluent supplied in the Hiberix™ package is replaced by the liquid vaccine.

Make sure the container of the vaccine intended for mixing with Hiberix™ is a monodose container. From the Hiberix™ package, discard the vial containing the diluent.

The combined vaccine must be reconstituted by adding the entire contents of the other vaccine container to the vial containing the Hib white pellet.

This extemporaneously combined vaccine should be handled in the same way as the monocomponent reconstituted Hiberix™ vaccine.