Technetium Tc-99m Albumin Aggregated Kit is a medicine sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Technetium Tc 99m Albumin Aggregated Kit (application BLA017881). Other technetium tc-99m albumin aggregated kit products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For lung scintigraphy, the following recommended activity is administered by intravenous injection: Adults: 37 MBq to 148 MBq (1 mCi to 4 mCi); 200,000 particles to 700,000 particles. (2.3) Pediatric patients aged 4 weeks and older : 0.925 MBq/kg to 1.85 MBq/kg of body weight (0.025 mCi/kg to 0.05 mCi/kg); The minimum activity is 7.4 MBq (0.2 mCi). The number of particles will vary with age and body weight of the pediatric patient. (2.3) Pediatric patients aged less than 4 weeks : 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi); 10,000 particles to 50,000 particles. (2.3) For scintigraphy of peritoneovenous shunts in adults: 37 MBq to 111 MBq (1 mCi to 3 mCi); 200,000 particles to 700,000 particles by intraperitoneal injection. (2.4) See Full Prescribing Information for radiation safety, patient preparation, drug preparation, administration, imaging, and radiation dosimetry information. (2.1 , 2.2 , 2.5 , 2.6 , 2.7) 2.1 Radiation Safety – Drug Handling After radiolabeling of DRAXIMAGE MAA, the vial contains Technetium Tc 99m Albumin Aggregated Injection. Handle Technetium Tc 99m Albumin Aggregated Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.4)]. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Albumin Aggregated Injection.…
The following clinically significant adverse reactions are described elsewhere in the labeling: Patients with Pulmonary hypertension [see Warnings and Precautions (5.1)]. Hypersensitivity Reactions [see Warnings and Precautions (5.2)]. The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including DRAXIMAGE MAA were 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. Cardiovascular Disorders : Deaths in patients with severe pulmonary hypertension Immune System Disorders : Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain and syncope, urticaria, reddening of the face, sweating, and nausea Skin and Subcutaneous Tissue Disorders : Injection site reactions The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction. (6) To…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
DRAXIMAGE MAA is contraindicated in patients with: Severe pulmonary hypertension [see Warnings and Precautions (5.1)]. A history of hypersensitivity to albumin human.Reactions have included anaphylaxis [see Warnings and Precautions (5.2)] . Severe pulmonary hypertension. (4) A history of hypersensitivity reactions to albumin human. (4)
| 3 | Not yet rated | Prescription | Injectable | — | — | View → |