In addition, a higher dose administration of Iomeron 350 syringe (135 ml formulation) also received approval.
Iomeron 350 and Iomeron 350 syringe are high concentration formulations of Iomeron. The approval is said to allow the intravenous administration at 1.8 ml/kg, and the dosage can be adjusted depending on the patient’s weight (up to 135ml). With these new formulations, contrast agent can be rapidly administered at the time of dynamic CT imaging using the multi-slice CT and patients with a higher body mass index can receive sufficient dosage for optimum imaging. A post-marketing surveillance will be conducted for the newly approved indication and dosage as an integral component of pharmacovigilance efforts to ensure safe usage of the products.
With this new indication and new high dose formulation of Iomeron, Eisai and Bracco-Eisai are expected to make further contributions to the improvement of liver disease diagnosis by dynamic CT imaging using the multi-slice CT as well as to decreasing patients’ burdens associated with such diagnostic procedures.