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DRAXIMAGE® MAA

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Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection

Indications

Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.

Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.

The radiopharmaceutical macroaggregated albumin (MAA) is used in the perfusion phase of a ventilation/perfusion (V/Q) scan to assess the flow of blood in the lungs. Jubilant DraxImage is the sole supplier of MAA in North America and is committed to maintaining its availability for healthcare professionals.

Comparing regional blood flow and regional ventilation enables physicians to obtain an accurate functional assessment of pulmonary pathophysiology for the non-invasive evaluation of pulmonary embolism (PE), differential lung function, or other specifically directed clinical questions on lung pathology.

Combining a pulmonary perfusion and ventilation study increases both the diagnostic sensitivity and specificity of the V/Q scan.

A V/Q scan provides diagnostic clarity comparable to CTPA with less risk of radiation overexposure. Learn more about the advantages of V/Q over CTPA in PE diagnosis.

Count on the Right Number of Particles

The recommended number of particles in a unit dose is at least 350,000. Learn more about the importance of getting the right particle count.

To prepare a dose of 350,000 particles with activity other than 93 MBq (2.5 mCi), please refer to the recommendations below.

Simplified Reconstitution Recommendations

DISCLAIMER:

This information is not intended as medical advice. Responsibility for patient care resides with the healthcare professional on the basis of his or her professional license, experience and knowledge of the patient. For full Prescribing Information including indications, contraindications, warnings, precautions and adverse events, please see the appropriate product labeling.

Product Overview

Product Name

Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection

Description

Each kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Albumin Aggregated Injection for diagnostic use by intravenous injection. Available in kits containing 30 reaction vials.

Indications

  • May be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients
  • May be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt

Contraindications

Technetium Tc 99m Albumin Aggregated Injection should not be administered to patients with severe pulmonary hypertension. The use of Technetium Tc 99m Albumin Aggregated Injection is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin.

Warnings

Although adverse reactions specifically attributable to Technetium Tc 99m Albumin Aggregated Injection have not been noted, the literature contains reports of deaths occurring after the administration of albumin aggregated to patients with pre-existing severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic reactions to preparations of technetium Tc-99m albumin aggregated have been reported.

Notes

  • The Human Albumin contained in the DRAXIMAGE® MAA kit was non-reactive when tested for Hepatitis-B Surface Antigen (HBsAg), antibodies to Human immunodeficiency Virus (HIV-1/HIV-2), antibody to Hepatitis C virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1). Each vial contains 4 to 8 million particles.
  • Tc 99m Albumin Aggregated Injection should not be administered to patients with severe pulmonary hypertension
  • In patients with right-to-left heart shunts, additional risk may exist due to the rapid entry of aggregated albumin into the systemic circulation.

Product Insert

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Safety Data Sheet

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Reference:

1. Stein EG, Haramati LB, Chamarthy M et al. Success of a safe and simple algorithm to reduced use of CT pulmonary angiography in the emergency department. Am J Roentgenol. 2010;194:392–397.

2. Pulmonary Embolism Diagnosis: www.draximage.com/vq4pulmonary embolism

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