Kit for the Preparation of Technetium Tc99m

Hepatolite®

Disofenin for Injection For Diagnostic Use

Product Information and Features

  • Specifically indicated to diagnose and rule out acute cholecystitis
  • Fast preparation is ideal for stat procedures
  • Effective imaging even in patients with elevated bilirubin levels
  • Proven hepatobiliary kinetics
  • Room-temperature storage both before and after reconstitution
  • Available in either 5 vial kits (HEP05) and 30 vial convenience packs (HEP30)

Indications and Usage

Technetium Tc99m Disofenin is indicated as a hepatobiliary imaging agent. Hepatolite is indicated in the diagnosis of acute cholecystitis as well as to rule out the occurrence of acute cholecystitis in suspected patients with right upper quadrant pain, fever, jaundice, right upper quadrant tenderness and mass or rebound tenderness, but not limited to these signs and symptoms.

IMPORTANT SAFETY INFORMATION

WARNINGS AND GENERAL PRECAUTIONS

The possibility of allergic reactions should be considered.

The preparation contains no bacteriostatic preservative. Technetium Tc99m Disofenin should be used within six hours of preparation.

In cases where there has been no visualization of the gallbladder after 60 minutes of scanning, morphine may be carefully administered provided there is no contraindication to the use of narcotics. There should be clear evidence of patency of the common duct, such as observed entry of radiopharmaceutical into the small bowel, prior to the administration of morphine to such patients.

Morphine augmentation has not been associated with any serious adverse events in the reported cases, but the administration of morphine in biliary colic may increase patient discomfort, and the recommended dose of 0.04mg/kg (2-4mg) may be associated with significant respiratory depression and/or postural syncope in vulnerable patients.

Facilities using morphine augmentation should be able to monitor patients for the adverse effects of narcotics and have the means at hand to manage them, including the ready availability of a specific narcotic antagonist such as naloxone.

Cholescintigraphy is only partially effective in the diagnosis or excluding the diagnosis of acute cholecystitis in other conditions such as trauma, intercurrent disease, total parenteral nutrition (TPN) and nothing by mouth (NPO) status, all of which frequently result in false positive results (non-visualization). False negatives (visualization) are rarely seen in certain patients with cholelithiasis (myriad of small stones).

ADVERSE REACTIONS

Itching at the site of injection progressing to erythema multiforme has been reported following single administration. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Technetium Tc 99m Hepatolite Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.