ProHance Injection 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
• ProHance vials are intended only for single-dose administration. Administer immediately after opening and discard any unused product

2.3 Directions for Use

Vials

• Draw ProHance into the syringe immediately before use. Do not pierce the rubber stopper more than once. Discard any unused vial contents.

ProHance single dose syringe*

• Screw the threaded tip of the plunger rod clockwise into the cartridge plunger and push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel

• Holding syringe erect, unscrew the plastic tip cap from the tip of the syringe and attach either a sterile, disposable needle or tubing with a compatible Luer lock using a push-twist action (slip tip)
• Hold the syringe erect and push plunger forward until all of the air is evacuated and fluid either appears at the tip of the needle or the tubing is filled
• Following the usual aspiration procedure, complete the injection
• Inject at least a 5 mL normal saline flush immediately after ProHance injection to ensure complete administration
• Properly dispose of the syringe and any other materials used

*The syringe assembly is a HYPAK SCF® single dose syringe supplied by Becton Dickinson