Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
 sodium acetate , Glacial Acetic acid, , water for injection

6.2   Incompatibilities
When necessary, Tambocor injection should be diluted with, or injected into, sterile solutions of 5% glucose. If chloride containing solutions, such as sodium chloride or Ringer’s lactate are used, the injection should be added to a volume of not less than 500 ml, otherwise a precipitate will form.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials 
Chemical and physical in-use stability of the diluted solutions have been demonstrated for 24 hours at room temperature.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4    Special precautions for storage

Do not store above 30°C. Do not freeze. Protect from light, and keep the ampules in the outer carton.

6.5    Nature and contents of container

Boxes containing 5 x 15 ml ampoules glass TYPE I.
6.6   Special precautions for disposal

No special requirements.