2.1 Recommended Dose
The recommended dose of AMBELVIST for adult and pediatric patients, including term neonates, is 0.01 mmol/kg actual body weight (equivalent to an injection volume of 0.1 mL/kg) administered intravenously.
Clarification on Gadolinium Content
- Each molecule of gadoquatrane contains four gadolinium (Gd) ions [see Description (11)].
- Therefore, the recommended dose of 0.01 mmol/kg of gadoquatrane (administered as AMBELVIST) delivers 0.04 mmol Gd/kg.
2.2 Administration and Imaging Instructions
- Administer AMBELVIST as an intravenous injection, manually or by compatible power injector, at a flow rate of approximately 1 mL/second to 4 mL/second, followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age.
- AMBELVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1)].
- Use aseptic technique when preparing and administering AMBELVIST.
- Visually inspect AMBELVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, particulate matter is present, or the container appears damaged.
- If solidification occurs due to cold exposure, bring AMBELVIST to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow.
- Do not mix AMBELVIST with other medications, and do not administer AMBELVIST in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.
- Contrast MRI can begin immediately following the injection of AMBELVIST.
2.3 Directions for Use of Single-Dose Containers
Single-Dose Vials:
- Pierce the rubber stopper only once.
- Aseptically draw AMBELVIST into the syringe immediately before use.
- Each vial of AMBELVIST is intended for one single dose. Discard any unused vial contents.
Single-Dose Pre-Filled Syringes:
- Remove the tip cap from the pre-filled syringe immediately before use.
- Each pre-filled AMBELVIST syringe is for one single dose. Discard any unused syringe contents.
2.4 Directions for Use of Imaging Bulk Package
- AMBELVIST 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.
- See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.
- The AMBELVIST IBP is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
- Utilize aseptic technique for penetrating the container closure of the AMBELVIST IBP and transferring AMBELVIST.
- 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 contrast agent in this IBP.
- Once the AMBELVIST IBP is punctured, do not remove it from the work area during the entire period of use. Storage temperature of AMBELVIST IBP after the closure has been entered is 20°C to 25°C (68°F to 77°F).
- Maximum use time is 6 hours from puncture. Discard any unused portion 6 hours after puncture of the IBP.
- After the container closure is punctured, if the integrity of the 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 (e.g., transfer spike) should be discarded.
2.5 Directions for Use of Pharmacy Bulk Package
- AMBELVIST Pharmacy Bulk Package (PBP) is not for direct infusion.
- The PBP is for use with an appropriate transfer device for filling empty sterile syringes.
- Perform the transfer of AMBELVIST from the PBP in an aseptic work area, such as a laminar flow hood, using aseptic technique.
- Penetrate the closure only one time. Once the PBP is punctured, do not remove it from the aseptic work area.
- Use each individual dose of AMBELVIST promptly following withdrawal from the PBP.
- Withdraw the contents of the PBP within 6 hours after puncture at 20°C to 25°C (68°F to 77°F). Discard any unused portion after 6 hours.