Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Amino acids for injection (containing phenylalanine)
Disodium phosphate anhydrous
Aluminium hydroxide
Potassium chloride
Monopotassium phosphate
Polysorbate 20
Water for injection

6.2   Incompatibilities
This vaccine should not be mixed with other vaccines.

6.3   Shelf life

The expiry date of the vaccine is indicated on the label and packaging.
6.4   Special precautions for storage

Store at 2°C - 8°C in a refrigerator.
Do not freeze.
Store in the original pack in order to protect from light.
Stability data indicate that Havrix is stable at temperatures up to 25°C for 3 days. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.


6.5   Nature and contents of container
Havrix 720 Junior:
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 or 0.5 mL of suspension in a vial (type I glass) with a stopper (butyl rubber) with or without needles.

Pack size:
Pre-filled syringe: 1 or 10 or 100
Vial: 1 or 100

Havrix 1440:
1 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap or 1 mL of suspension in a vial (type I glass) with stopper (butyl rubber) with or without needles.
Pack size of 1.

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

The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. Before use, the vaccine should be well shaken to obtain a slightly opaque, white suspension. Discard the vaccine if the content appears otherwise.

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.