DRAXIMAGE DTPA

After an intravenous administration, the pharmacokinetics of Technetium Tc 99m pentetate were studied by monitoring radioactivity in serial venous blood samples for 7 hours post-administration. The mean plasma clearance rate was 6.8 (L/h) and the mean plasma elimination half-life (t½) was 2.1 hours. The mean volume of distribution at steady state conditions calculated with clearance and mean residence time was 17 L. This relatively low volume of distribution after intravenous administration sugg...

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, i...

Hypersensitivity to the active ingredient or to any component of the product [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to the active ingredient or any component of this product ( 4 ).

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 ( 5.1 ). Image interpretation risks in lung ventilation studies: If proximal airway deposition is observed, consider additional diagnostic options ( 5.2 ). Radiation exposure risk: Technetium Tc 99m pentetate contributes to a patient’s overall long-term radiation exposure...