PHARMACOVIGILANCE

Case Report for Pharmacovigilance (PV) Events

To report a Pharmacovigilance (PV) event locally (Costa Rica), as well as to report any problems that may take place with the contrast agents distributed from the brand GUERBET, please proceed to send an email to any of the following contacts:

Email must include enough detailed information, as indicated below:

To report Adverse Reactions/Events:

  • Exact evento date,
  • Detailed description of the reaction.
  • Name of the contrast agent used and batch number.
  • Doses injected and type of study being performed.
  • Actions taken by medical personnel, including the posible application of concomitant medications and/or adjuvants.
  • Sex, age and weight of the patient.
  • Patient ailments.
  • Treatments and/or medications taken by the patient.
  • Local report number for the case report with the local authorities.
  • Contact information for the person that reports the case: Complete name, position, email and phone number

To report Quality problems:

  • Name of the contrast agent used and batch number.
  • Detailed description of the problem: indicate if it’s a packing issue or if the problem is related to therapeutic issues (drug performance does not comply with the diagnostic qualities in it’s indication).
  • Contact information for the person that reports the case: Complete name, position, email and phone number.

To report cases/problems outside Costa Rica

  • Please contact your local distributor for GUERBET products.