ELUCIREM

2 DOSAGE AND ADMINISTRATION The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of ELUCIREM for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. 2.2 Administration and Imaging Instructions Administer ELUCIREM as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of ELUCIREM. Visually inspect ELUCIREM for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of ELUCIREM. 2.3 Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up ELUCIREM into a disposable syringe and use immediately. If solidification occurs in the vial due to cold exposure, bring the vial of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. Discard any unused portion. Pre-filled syringe Remove the tip cap of the syringe, screw the plunger rod and use immediately. All luer connections should be gently hand tightened without over tightening, to ensure secure connections and to prevent damage to the device. Pre-filled syringes must not be frozen. Frozen pre-filled syringes of ELUCIREM should be discarded. Discard any unused portion. 2.4 Directions for Use of Pharmacy Bulk Package ELUCIREM Pharmacy Bulk Package (PBP) is not for direct infusion. Perform the transfer of ELUCIREM from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time. Once the container closure is punctured, do not remove the PBP from the aseptic work area. Use each individual dose of ELUCIREM promptly following withdrawal from the PBP. Use the contents of the PBP within 24 hours at room temperature after puncture. If solidification occurs in the PBP due to cold exposure, bring the PBP of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. 2.5 Directions for Use of Imaging Bulk Package ELUCIREM Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. This allows for the administration of multiple single doses of ELUCIREM to multiple patients. See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use. The ELUCIREM IBP is to be used only in a room designated for performing radiological procedures that involve administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the IBP and transferring ELUCIREM. Penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set (e.g., transfer spike) approved or cleared for use with this IBP. During the entire period of use, ensure that the contents of the ELUCIREM IBP container remain in continuous contact with the automated contrast injector system, contrast management system, or contrast media transfer set. To ensure the protection of the contrast media against any possible contamination, do not remove the dispensing set from the IBP container closure. Once the ELUCIREM IBP container is punctured, do not remove it from the work area. Store the ELUCIREM IBP at 25° C (77° F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Maximum use time from puncture is 24 hours. Discard any unused ELUCIREM 24 hours after puncture of the IBP. After the container closure is punctured, if the integrity of IBP and the delivery system cannot be assured through direct continuous supervision, the IBP and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded. If solidification occurs in the IBP due to cold exposure, bring the IBP of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.

See official label

1 INDICATIONS AND USAGE ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).