Albumin aggregated

PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. PULMOTECH MAA, after radiolabeling with technetium-99m is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.

Within 1 to 5 minutes of intravenous injection, over 90 percent of the technetium Tc 99m albumin aggregated particles are trapped in the arterioles and capillaries of the lung. Following intraperitoneal administration, technetium Tc 99m albumin aggregated mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent.

For lung perfusion scintigraphy, the following recommended activity is administered by intravenous injection. • Adults: 37 MBq to 148 MBq (1 mCi to 4 mCi) and 200,000 particles to 700,000 particles. • Pediatric patients aged 4 weeks and older: 0.925 MBq/kg to

PULMOTECH MAA is contraindicated in patients with: Severe pulmonary hypertension. A history of hypersensitivity to albumin human. Reactions have included anaphylaxis. Severe pulmonary hypertension. A history of hypersensitivity reactions to albumin human.

Patients with P ulmonary H ypertension: Administer the lowest number of particles possible and have emergency resuscitation equipment available. Hypersensitivity Reactions: Have emergency resuscitation equipment and trained personnel available. Interrupt the administration if a reaction occurs during administration. Monitor patients. Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts: Administer the lowest possible number of particles. Radiation Risks: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers.

The following clinically significant adverse reactions are described elsewhere in labeling: Patients with Pulmonary Hypertension. Hypersensitivity Reactions. The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Before radiolabeling, store supplied reaction vials at 2°C to 25°C (36°F to 77ºF). After radiolabeling with Sodium Pertechnetate Tc 99m Injection, store Technetium Tc 99m Albumin Aggregated Injection in a lead vial shield with cap in place, refrigerated at 2°C to 8°C (36°F to 46ºF) when not in use.