Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Adjuvant: see section 2.

Other: sodium chloride, disodium phosphate dihydrate, potassium chloride, potassium dihydrogen phosphate, calcium chloride dihydrate magnesium chloride hexahydrate, and water for injections.

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 product is indicated on the packaging materials 
6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5   Nature and contents of container

0.5 ml of suspension in pre-filled syringe (type I glass), presented with or without needle.
Pack of 1, with or without needle.
Pack of 10x, with or without needle.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

The vaccine should be allowed to reach room temperature before use. Gently shake before use.
After shaking, the normal appearance of Fluad is a milky-white suspension.
Visually inspect the contents of each Fluad pre-filled syringe for particulate matter or discoloration prior to administration. If either condition is observed, do not use the contents.
When using a pre-filled syringe supplied without a needle, remove the tip cap from the syringe and then attach a suitable needle for administration.
Do not use if the vaccine has been frozen.
Any unused product or waste material should be disposed of in accordance with local requirements.