Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sodium chloride
Water for injections
Sulphuric acid and sodium hydroxide
6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with any other medicinal product in the nebuliser.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
For single use. The contents of the whole ampoule should be used immediately after opening (see section 6.6).
Discard any remaining contents.

6.4     Special precautions for storage

Store under refrigeration at 2-8°C. Store in the original package in order to protect from light and moisture. Do not freeze.

Foil pouches (opened or unopened) may be stored at room temperature up to 25°C for up to 28 days.

TOBI solution is normally slightly yellow, but some variability in colour may be observed, which does not indicate loss of activity if the product has been stored as recommended.

6.5     Nature and contents of container

TOBI is supplied in 5 mL single-use low density polyethylene ampoules. One outer carton contains a total of 56 ampoules comprising 14 sealed foil pouches. Each foil pouch contains 4 ampoules.

6.6     Special precautions for disposal and other handling

TOBI is a sterile, non-pyrogenic, aqueous preparation for single use only. As it is preservative-free, the contents of the whole ampoule should be used immediately after opening and any unused solution discarded. Opened ampoules should never be stored for re- use.