The ISOVUE Imaging Bulk Package is used for dispensing multiple single doses of iopamidol injection for multiple patients, using an automated contrast injection system contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. Preparations of 0.9% Sodium Chloride Injection USP, with a sterile port for an intravenous administration set, are to be used with the ISOVUE Imaging Bulk Package and automated contrast injection systems or contrast management systems approved for use with the ISOVUE Imaging Bulk Package. Please see drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.

  1. The ISOVUE Imaging Bulk Package is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
  2. The transferring of ISOVUE from the Imaging Bulk Package should be performed utilizing aseptic technique. Prior to penetrating the container closure, swab the face of the container stopper with 70% isopropyl alcohol. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this Imaging Bulk Package.
  3. Once the Imaging Bulk Package is punctured, it should not be removed from the work area during the entire period of use, and the bottle should be maintained in an inverted position such that container contents are in continuous contact with the dispensing set. 
  4. A maximum use time of 10 hours from initial closure entry is permitted to complete fluid transfer. Any unused ISOVUE injection must be discarded 10 hours after initial puncture of the Imaging Bulk Package.
  5. After the container closure is punctured, if the integrity of the Imaging Bulk Package and the delivery system cannot be assured though direct continuous supervision, the Imaging Bulk Package and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded.
  6. Storage temperature of the ISOVUE Imaging Bulk Package container after the closure has been entered should not exceed 25° C (77° F); however, it is desirable that the contents be warmed to body temperature prior to injection.
  7. If 0.9% Sodium Chloride Injection USP is used, prepare the intravenous port in accordance with the DOSAGE AND ADMINISTRATION section of the approved prescribing information of the product.
  8. Multiple-dose use of 0.9% Sodium Chloride Injection USP:
     * 0.9% Sodium Chloride Injection USP should only be used to deliver multiple doses to multiple patients when used with an automated contrast injection system or contrast management system approved or cleared for multiple-dose use of 0.9% Sodium Chloride Injection.
     * The intravenous administration port of the sodium chloride container may be penetrated only one time with a suitable sterile component of the contrast management system approved for use with the ISOVUE Imaging Bulk Package, using aseptic technique. A maximum use time of 10 hours from initial closure entry is permitted to complete the fluid transfer. Any unused sodium chloride must be discarded 10 hours after initial puncture of the 0.9% Sodium Chloride Injection USP container. The container of 0.9% Sodium Chloride Injection USP is to be used only in an area designated for radiological procedures that involve intravascular administration of contrast. All above instructions in c. through e. for the ISOVUE Imaging Bulk Package should be followed for the 0.9% Sodium Chloride Injection USP container. Strap the saline tag provided with the ISOVUE Imaging Bulk Package on the 0.9% Sodium Chloride Injection USP container.
  9. Single-dose use of 0.9% Sodium Chloride Injection USP: Use in accordance with the manufacturers Prescribing Information.