Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Hydrochloric acid 0.36% (for pH adjustment)
Sodium hydroxide 0.4% (for pH adjustment)
Water for injections
6.2 Incompatibilities
Studies carried out on alkaline solutions, showed that ropivacaine has poor solubility at pH > 6.0 and therefore precipitation may occur.

6.3 Shelf-life
Unopened: The expiry date of the product is indicated on the packaging materials
Shelf life after first opening: For microbiological reasons, the product should be used immediately. If it is not used immediately, storage times and conditions prior to use are the responsibility of the user. The ready-to-use preparation must not be stored longer than 24 hours at 2 to 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

6.4 Special precautions for storage
Store below 30°C. Do not freeze.

6.5 Nature and contents of container
10 ml and 20 ml polyethylene (LDPE) ampoules in packs of 20.
The LDPE ampoules are specially designed to fit Luer lock and Luer fit syringes.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
The solution for injection is preservative free and is intended for single use only. Discard any unused solution.
The intact container must not be re-autoclaved.
The medicinal product is to be visually inspected prior to use: only clear solutions practically free from particles should be used.