Last Updated on eMC 22-06-2017 View medicine  | Panpharma UK Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC:20-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



3 years.

After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.

 

From a microbiological point of view, once reconstituted, the product must 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 oC to 8oC (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.

.

 

After dilution, chemical and physicial in-use stability has been demonstrated for three hours at 20oC to 25oC. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO