Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Phenoxyethanol
Water for injections

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

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials 
6.4    Special precautions for storage

Store in a refrigerator at 2°C to 8°C.
Do not freeze. Discard the vaccine if it has been frozen.
Keep the container in the outer carton in order to protect from light.
6.5    Nature and contents of container

ADACEL is supplied in 0.5 mL single dose glass vials.
The vials are made of Type 1 glass. The container closure system of ADACEL is free of latex (natural rubber).
ADACEL is available in a package of:
1 single dose vial
5 single dose vials


Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling

Instructions for use

Parenteral products should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. In the event of either being observed, discard the medicinal product.

The normal appearance of the vaccine is a uniform, cloudy, white suspension which may sediment during storage. Shake the vial well to uniformly distribute the suspension before administering the vaccine.

When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place.

Disposal

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

Needles should not be recapped.