Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Acetic acid, glacial
Sodium acetate trihydrate
Sodium chloride
Sodium hydroxide
Water for injections
6.2. Incompatibilities
Oxytocin should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by oxytocin-inactivating enzymes. Oxytocin is incompatible with solutions containing sodium metabisulphite as a stabiliser.
6.3. Shelf life
The expiry date of the product is indicated on the packaging materials.
For singles use. For immediate use after opening. Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C when diluted with the solutions stated in section 6.6. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4. Special precautions for storage
Store between 2°C and 8°C. Do not freeze.
See section 6.3 for storage of diluted product.
6.5. Nature and contents of container
Transparent 1 ml PhEur type I glass ampoules.
Pack sizes:
5 ampoules
10 ampoules
Not all pack sizes may be marketed.

6.6 Special precautions for disposal
Oxytocin is compatible with the following infusion fluids: sodium chloride 0.9%, dextrose 5%, Ringer's solution, acetated Ringer's solution.

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