Recommendation on the sterile removal of the primary cement powder bag for PALACOS® LV+G, PALACOS® MV+G, PALACOS® R+G

A Dear Healthcare Professional Letter has been issued by Indola Pharma to inform that in individual cases, the secondary bag (polyethylene paper bag) of the bone cement products Palacos Bone cements (LV+G, MV+G, R+G) may tear on opening, making sterile removal of the primary bag (cement powder bag) difficult. The reduced ability of the secondary bag to be torn open occurs due to excessive tensile strength of the sealed seam. Given identical sealing parameters, the batches of packaging material affected exhibit higher tensile strength of the sealed seams, which all however conform with the applicable standards. Healthcare professionals are advised to follow the recommendations described in the letter to prevent the secondary bag from being torn open. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.