Pentetic acid

DRAXIMAGE ® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults. Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients. Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients.

Intravenous Administration Following intravenous administration for brain and renal imaging, Technetium Tc 99m pentetate is distributed in the vascular compartment. It is cleared by the kidneys, which results in the ability to image the kidney. Aerosolized Inhalation Administration Following inhalation of the aerosol, Technetium Tc 99m pentetate deposits on the epithelium of ventilated alveoli.

During preparation and handling, use water proof gloves and effective shielding, to minimize radiation exposure. See the Full Prescribing Information for detailed information regarding recommended Dosage and Image Acquisition Instructions and Instructions for Drug Preparation. Do not administer more than one dose.

Hypersensitivity to the active ingredient or to any component of the product. Hypersensitivity to the active ingredient or any component of this product.

Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions. Image interpretation risks in lung ventilation studies: If proximal airway deposition is observed, consider additional diagnostic options. Radiation exposure risk: Technetium Tc 99m pentetate contributes to a patient’s overall long-term radiation exposure. Bronchospasm in lung ventilation studies: Inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity.

The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m pentetate exposure. Adverse reactions are presented in decreasing order of reported frequency: Immune system disorders: allergic reaction, anaphylactic reaction, angioedema. Skin and subcutaneous tissue disorders: rash, itching, hives, erythema. Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing. Vascular disorders: hypotension, hypertension. Nervous system disorders: headache, fainting, dizziness. General disorders and administration site conditions: chills. Gastrointestinal disorders: nausea, vomiting. Cardiac disorders: cyanosis, tachycardia.

Store the unreconstituted reaction vials at 25 °C (77 °F), excursions permitted between 15 °C and 30 °C (59 °F and 86 °F).