Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Sodium hydroxide or hydrochloric acid (for pH adjustment)
Water for injection

6.2 Incompatibilities
Alkalisation can cause precipitation as bupivacaine is poorly soluble at pH above 6.5.
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
From a microbiological point of view, the product should be used immediately.

6.4 Special precautions for storage
Do not store above 25ºC. Do not freeze.

6.5 Nature and contents of container
10 ml of the solution for injection in Type I hydrolytic class colourless borosilicate glass ampoule with break line or one point cut.
5 ampoules are packed in a polyvinylchloride film liner.
1 liner is packed in a cardboard box.


6.6 Special precautions for disposal and other handling
For single use only. Solution for injections does not contain preservatives and should be used immediately after opening. Discard any unused solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


The solution for injection must not be kept in such a way that it can act on metals, e.g. in needeles or syringes with metal parts. Metal ions can otherwise become dissolved in the solution, which may lead to cause swelling at the injection site.