Pharmaceutical particulars : מידע רוקחי

6        PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Sodium chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injections

For adsorbent, see section 2.

6.2     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

The expiry date of the vaccine is indicated on the packaging materials.

6.4     Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze; Do not use if the vaccine has been frozen.
Store in the original package, in order to protect from light
6.5     Nature and contents of container

Engerix B10MCG
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.


Pack sizes of 1,10,25 and 50, with or without needles.

0.5 ml of suspension in a vial (type I glass) with a stopper (butyl rubber).
Pack sizes of 1, 10, 25,50 and 100.

The tip cap and rubber plunger stopper of the pre-filled syringe and the stopper of the vial are made with synthetic rubber.


Engerix B20MCG
1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
Pack sizes of 1, 10 , 25, 50 and 100, with or without needles.


1 ml of suspension in a vial (type I glass) with a stopper (butyl rubber).
Pack sizes of 1, 10, 25, 50 and 100.
The tip cap and rubber plunger stopper of the pre-filled syringe and the stopper of the vial are made with synthetic rubber.


Not all pack sizes may be marketed

6.6   Special precautions for disposal and other handling

Shake before use.
Upon storage, the content may present a fine white deposit with a clear colourless supernatant. Once shaken the vaccine is slightly opaque.

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, do not administer the vaccine.

The entire contents of a mono-dose container must be withdrawn and should be used immediately.

Instructions for the pre-filled syringe



Luer Lock Adaptor
Hold the syringe by the barrel, not by the plunger.
Plunger                                 Unscrew the syringe cap by twisting it anticlockwise.
Barrel
Cap



Needle hub                To attach the needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.



Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.