Prohance (Gadoteridol) - Indications and Dosage

INDICATIONS AND USAGE

Central Nervous System

ProHance (Gadoteridol) Injection is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues

ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

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.

Extracranial/Extraspinal Tissues

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.

HOW SUPPLIED

ProHance (Gadoteridol) Injection is a clear, colorless to slightly yellow solution containing 279.3 mg/mL of gadoteridol in rubber stoppered vials. ProHance is available in boxes of:

Five 5 mL fills in single dose 15 mL vials	(NDC 0270-1111-04)
Five 10 mL fills in single dose 30 mL vials	(NDC 0270-1111-01)
Five 15 mL fills in single dose 30 mL vials	(NDC 0270-1111-02)
Five 20 mL fills in single dose 30 mL vials	(NDC 0270-1111-03)
Five 10 mL fills in single dose 20 mL prefilled syringes	(NDC 0270-1111-16)
Five 17 mL fills in single dose 20 mL prefilled syringes	(NDC 0270-1111-45)

STORAGE

ProHance (Gadoteridol) Injection should be stored at 25° C (77° F) excursions permitted to 15-30° C (59-86° F) [See USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE. Should freezing occur in the vial, ProHance should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 60 minutes, ProHance (Gadoteridol) Injection should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial. Frozen syringes should be discarded.

Directions for Use of the
ProHance^® (Gadoteridol) Injection single dose syringe *

1) 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.

2) Holding syringe erect, aseptically remove the rubber 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.

3) 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. To ensure complete delivery of the contrast medium, the injection should be followed by a normal saline flush.

4) Properly dispose of the syringe and any other materials used.

This product is covered by one or more of:
U.S. Patent No. 4,885,363; U.S. Patent No. 4,963,344; U.S. Patent No. 5,474,756; U.S. Patent No. 5,846,519; and U.S. Patent No. 6,143,274.

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