Update to Singapore package insert of Prostin E2 Vaginal Tablet

A Dear Healthcare Professional Letter has been issued by Pfizer Pte Ltd to inform healthcare professionals that the package insert of Prostin E2 Vaginal Tablet (dinoprostone) have been updated to strengthen the risk minimisation measures to manage the known risk of foetal and neonatal death associated with uterine hyperstimulation and uterine rupture. The new safety information includes a statement to restrict usage to qualified healthcare professionals and hospitals and clinics with specialised obstetric units that have facilities for continuous monitoring. Other information includes warnings against exceeding the maximum recommended dose or shortening the dosing interval, advice to consider concomitant medicine as well as maternal or foetal status, and documentation of this safety issue in the package insert. Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

9 Sep 2021

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.