Pharmaceutical particulars : מידע רוקחי

6           PHARMACEUTICAL PARTICULARS

6.1         List of excipients
Sodium Chloride
Histidine
Polysorbate 80 (PS80)
Water for injections
For adsorbent, see section 2.

6.2         Incompatibilities

Do not mix Trumenba with other vaccines or medicinal products in the same syringe.
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).
Syringes should be stored in the refrigerator horizontally to minimize the re-dispersion time.
Do not freeze.
6.5     Nature and contents of container

0.5 ml suspension in a pre-filled syringe (Type I glass) with plastic Luer Lok adapter, chlorobutyl rubber plunger stopper, and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap cover with or without needle. The tip cap and rubber plunger of the pre- filled syringe are not made with natural rubber latex.

Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needle.

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

During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension.

Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white suspension is obtained.

Do not use the vaccine if it cannot be re-suspended.

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

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