DOSAGE AND ADMINISTRATION
Central Nervous System
ADULTS: The recommended dose of ProHance (Gadoteridol) Injection is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min). In patients suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans, a second dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose.
CHILDREN (2-18 years): The recommended dose of ProHance is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min). The safety and efficacy of doses > 0.1 mmol/kg, and sequential and/or repeat procedures has not been studied.
ADULTS: The recommended dose of ProHance is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min).
CHILDREN: Safety and efficacy for extracranial/extra-spinal tissues has not been established.
Dose adjustments in renal and liver impairment have not been studied.
To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL normal saline flush. The imaging procedure should be completed within 1 hour of the first injection of ProHance (Gadoteridol) Injection.
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.
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
Directions for Proper Use of ProHance (Gadoteridol) Injection Pharmacy Bulk Package
The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes.
ProHance Multipack Injection should be drawn into the syringe and administered using sterile technique. If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. Unused portions of the drug must be discarded.
When ProHance Multipack Injection is to be injected using plastic disposable syringes, the agent should be drawn into the syringe and used immediately.
- The transferring of ProHance (Gadoteridol) Injection from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique.
- The container closure may be penetrated only one time, utilizing a suitable transfer device. Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use.
- The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operation. Any unused ProHance Multipack Injection must be discarded 8 hours after initial puncture of the bulk package.
- Storage temperature of container after the closure has been entered should not exceed 25° C (77° F).