When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Chemical and physical in-use stability has been demonstrated for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with 8.3-8,4 mg/ml clonidine, 50 mg /ml morphine and 2 mg /ml fentanyl, respectively, stored for 30 days at either 2-8ºC or 20–22°C. Chemical and physical in-use stability has been demonstrated for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with sufentanil added in the concentration of 0.4 mg /ml and stored for 30 days at 2-8ºC or 7 days at 20–22°C.
From a microbiological point of view, the product should be used immediately after opening. 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 2-8ºC, unless the admix has been prepared in controlled and validated aseptic conditions.