ProHance Dosage

2.1 Recommended Dose

The recommended dose for adult and pediatric patients, including term neonates, is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). Table 1 provides weight-adjusted recommended dose volumes.

MRI of the CNS in Adults:

• A supplementary dose of 0.4 mL/kg (0.2 mmol/kg) may be given up to 30 minutes after the first dose in adult patients with normal renal function suspected of having poorly visualized CNS lesions, in the presence of negative or equivocal scans
• The safety and efficacy of supplementary dosing have not been established in pediatric patients

2.2 Administration

• Visually inspect ProHance for particulate matter and discoloration prior to use
• Do not administer the solution if it is discolored or particulate matter is present
• Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility
• Inject at least a 5 mL normal saline flush immediately after ProHance injection to ensure complete administration
• Imaging procedures should be completed within 1 hour

2.3 Directions for Proper Use of Pharmacy Bulk Package

NOT FOR DIRECT INFUSION
The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedures when transferring ProHance from the pharmacy bulk package to individual syringes:

• Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique
• Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent
• The container closure may be penetrated only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents
• Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use
• Withdrawal of container contents should be accomplished without delay. A maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations
• Any unused contents must be discarded by 8 hours after initial puncture of the bulk package
• Once drawn into syringe, administer transferred agent promptly for single-dose administration