Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride,
Sodium metabisulfite,
Water for injection.
The pH may be adjusted with sodium hydroxide or sulfuric acid solution.
6.2   Incompatibilities
Morphine salts are sensitive to changes in pH and morphine is liable to be precipitated out of solution in an alkaline environment. Compounds incompatible with morphine salts include aminophylline and sodium salts of barbiturates and phenytoin. Other incompatibilities (sometimes attributed to particular formulations) have included aciclovir sodium, doxorubicin, fluorouracil, frusemide, heparin sodium, pethidine hydrochloride, promethazine hydrochloride and tetracyclines.
Specialised references should be consulted for specific compatibility information.
Physicochemical incompatibility (formation of precipitates) has been demonstrated between solutions of morphine sulfate and 5-fluorouracil.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage
Store below 25°C.
Keep the ampoules in the outer carton in order to protect from light.

6.5   Nature and contents of container
Clear, colourless 1ml Ph.Eur type1 glass ampoules containing sufficient solution to permit the removal of 1 ml. 10 ampoules are packed into a cardboard carton.

6.6   Special precautions for disposal and other handling Any solution remaining should be discarded or returned to the pharmacy.