during the original registration medication error. This risk application of Eylea. The can be minimised by apparent excess in the amending the package extractable volume compared to and/or amending the the actual volume needed for vial/PFS label, by clearly injection was considered in the indicating, that the volume final CMC Evaluation as required for injection acceptable based on the differs from the total following justifications: volume provided. The excess contained in the Alternatively, educational extractable volume in the material informing treating glass vial (100 µL) and physicians about the prefilled syringe (90 µL) is posology of the product required to compensate for may be distributed by the the volume” (that is, sponsor. “priming the volume required to expel all the air from the syringe and properly prime the needle prior to administering the intravitreal injection), and the dead “average volume of the syringe and needle” in order to deliver the volume dose of 50 µL required for administration when the product is administered according to the recommended instructions provided in the labelling. The extractable volume in both the vial and prefilled syringe is determined using the current European Pharmacopiea (Ph. Eur) procedure and represents the minimum extractable volume necessary to enable the end user to remove the required volume of solution (50 µL) for a single dose. From the user testing that has been performed during pharmaceutical development, it is evident that based on the minimum fill volume contained in the glass vial and prefilled syringe, it would not be possible to reproducibly administer more than one single dose from each glass vial or prefilled syringe.
during the original registration application of Eylea. The apparent excess in the extractable volume compared to the actual volume needed for injection was considered in the final CMC Evaluation as acceptable based on the following justifications: The excess contained in the extractable volume in the glass vial (100 µL) and prefilled syringe (90 µL) is required to compensate for the “priming volume” (that is, the volume required to expel all the air from the syringe and properly prime the needle prior to administering the intravitreal injection), and the “average dead volume of the syringe and needle” in order to deliver the volume dose of 50 µL required for administration when the product is administered according to the recommended instructions provided in the labelling. The extractable volume in both the vial and prefilled syringe is determined using the current European Pharmacopiea (Ph. Eur) procedure and represents the minimum extractable volume necessary to enable the end user to remove the required volume of solution (50 µL) for a single dose. From the user testing that has been performed during pharmaceutical development, it is evident that based on the minimum fill volume contained in the glass vial and prefilled syringe, it would not be possible to reproducibly administer more than one single dose from each glass vial or prefilled syringe. medication error. This risk can be minimised by amending the package and/or amending the vial/PFS label, by clearly indicating, that the volume required for injection differs from the total volume provided. Alternatively, educational material informing treating physicians about the posology of the product may be distributed by the sponsor.
auspar-aflibercept-rch-140804.docx