DRAXIMAGE MAA Kit for the preparation of Technetium Tc 99m Albumin aggregated 2.5 mg Injection, Powder, For Solution, 30-count — NDC 65174-270-30 (Billing 65174-0270-30)
This is a package of 30 injections of DRAXIMAGE MAA Kit for the preparation of Technetium Tc 99m Albumin aggregated 2.5 mg Injection, Powder, For Solution from Jubilant DraxImage Inc, marketed since Dec 1987 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 65174-270-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 65174 labeler · 270 product · 30 package
- Package marketed since
- Dec 30, 1987
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6517427030 8
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 067659
- GCN: 30265
- HICL (First Databank): 024536
- AHFS class code: 36:68.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 65174-0270-30 You're viewing this Main listing | 30 INJECTION, POWDER, FOR SOLUTION in 1 KIT | 1987-12-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Draximage Maa 2.5 mgthis 65174-0270-30 | Jubilant | 30 injections | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
5 mg
UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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1.2 mg
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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0.06 mg
UNII 1BQV3749L5
Stannous chloride is a tin-based chemical compound used as a reducing agent and antioxidant in pharmaceuticals. It helps prevent oxidation of active ingredients and stabilizes certain formulations, particularly in products requiring preservation of potency.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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Manufacturer & labeler
More NDCs from Jubilant DraxImage Inc labeler code 65174
- RUBY-FILL Rubidium Rb 82 100 mCi Injection, Solution NDC 65174-021-10
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Kit NDC 65174-179-01
- Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling .5 mg Injection, Powder, Lyophilized, For Solution NDC 65174-200-05
- TECHNETIUM Tc 99m MERTIATIDE 1 mg Injection, Powder, Lyophilized, For Solution NDC 65174-261-05
- DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate 20 mg Injection, Powder, Lyophilized, For Solution NDC 65174-288-30
- Sodium Iodide I 131 Diagnostic 100 mCi Capsule NDC 65174-461-05
- Technetium Tc 99m Medronate 25 mg Injection, Powder, For Solution NDC 65174-660-30
- HICON Sodium Iodide I 131 1000 mCi/mL Solution NDC 65174-880-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 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 adult patients. DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is a radioactive diagnostic agent indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
(1) Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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
1.85MBq/kg of body weight (0.025 mCi/kg to 0.05 mCi/kg); The minimum activity is
7.4MBq (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
18.5MBq (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)
2.1Radiation 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.
Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
2.2Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Albumin Aggregated Injection and to continue to drink and void frequently following administration to reduce radiation exposure [see Warnings and Precautions (5.4)].
2.3Recommended Dosage for Lung Perfusion Scintigraphy Adult Patients The recommended activity for lung perfusion scintigraphy in adult patients is 37 MBq to 148 MBq (1 mCi to 4 mCi) by intravenous injection. The number of particles per single injection should be 200,000 to 700,000 with the recommended number being approximately 350,000. Depending on the activity added and volume of the final radiolabeled product, the volume of the dose may vary from 0.2 mL to 1.9 mL.
The number of particles available per dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the technetium-99m that has occurred. The number of particles in any dose and volume to be administered may be calculated as follows: V a = D and P = V a x N C x F r V Tc Where: V a = Volume to be administered in mL D = Desired activity to be administered in MBq (mCi) C = Concentration at calibration time of Sodium Pertechnetate Tc 99m Injection to be added to the reaction vial in MBq/mL (mCi/mL) F r = Fraction of technetium-99m remaining after the time of calibration from Table 7 [see Description (11.3)] P = Number of particles in dose to be administered V a = Volume to be administered in mL V Tc = Volume of Sodium Pertechnetate Tc 99m Injection added to reaction vial in mL N = Number of particles per vial.
The number of particles per vial for each lot is shipped with the product. Pediatric Patients Aged 4 Weeks and Older The recommended activity for lung perfusion scintigraphy in pediatric patients aged 4 weeks and older by intravenous injection is based on body weight and ranges from 0.925 MBq/kg to
1.85MBq/kg (0.025 mCi/kg to 0.05 mCi/kg). The minimum recommended activity for lung perfusion scintigraphy in this age group is
7.4MBq (0.2 mCi). The number of particles will vary with age and body weight of the pediatric patient. Particle numbers administered in four different age and weight categories are… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection: 2.5 mg of albumin aggregated as a non-radioactive white lyophilized powder in a multiple-dose reaction vial for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare a suspension of Technetium Tc 99m Albumin Aggregated Injection. Each vial contains 3,000,000 to 8,000,000 particles. Kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection: 2.5 mg of albumin aggregated as a lyophilized powder in a multiple-dose reaction vial.
Upon radiolabeling, it provides a suspension of Technetium Tc 99m Albumin Aggregated Injection. Each vial contains 3,000,000 to 8,000,000 particles. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Patients with Pulmonary Hypertension: Administer the lowest number of particles possible and have emergency resuscitation equipment available. (5.1) Hypersensitivity Reactions: Have emergency resuscitation equipment and trained personnel available. Interrupt the administration if a reaction occurs during administration.
Monitor patients. (5.2) Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts: Administer the lowest possible number of particles. (5.3) Radiation Risks: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers.
(5.4)
5.1Patients with Pulmonary Hypertension Deaths have been reported in patients with severe pulmonary hypertension after the administration of technetium Tc 99m albumin aggregated products [see Adverse Reactions (6)]. Assess patients for history or signs of pulmonary hypertension. DRAXIMAGE MAA is contraindicated in patients with severe pulmonary hypertension [see Contraindications (4)].
Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions.
5.2Hypersensitivity Reactions Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with products containing albumin human, including DRAXIMAGE MAA [see Adverse Reactions (6)]. Obtain a history of allergy or hypersensitivity reactions. DRAXIMAGE MAA is contraindicated in patients with a history of hypersensitivity to albumin human [see Contraindications (4)] .
Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Monitor all patients for signs or symptoms of hypersensitivity reactions.
5.3Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts In patients with right-to-left heart shunts, risk for temporary mechanical impediment to blood flow may exist due to the rapid entry of aggregated albumin into the systemic circulation. Administer the lowest possible number of particles of Technetium Tc 99m Albumin Aggregated Injection in these patients.
5.4Radiation Risks Technetium Tc 99m albumin aggregated contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.2)].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 24 hours after Technetium Tc 99m Albumin Aggregated Injection administration. (8.2)
8.1Pregnancy Risk Summary Available data with Technetium Tc 99m Albumin Aggregated Injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted Radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. The radiation exposure to the fetus from technetium Tc 99m albumin aggregated is expected to be low (less than 0.5 mGy) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
8.2Lactation Risk Summary Technetium-99m is present in breast milk. There are no data on the effects of technetium Tc 99m albumin aggregated on the breastfed infant or the effects on milk production. DRAXIMAGE MAA is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower.
Based on clinical guidelines, exposure of technetium Tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of Technetium Tc 99m Albumin Aggregated Injection. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for DRAXIMAGE MAA, any potential adverse effects on the breastfed child from technetium Tc 99m albumin aggregated or from the underlying maternal condition.
8.4Pediatric Use DRAXIMAGE MAA, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). The safety profile of Technetium Tc 99m Albumin Aggregated Injection in pediatric patients is similar to adults. The safety and efficacy of DRAXIMAGE MAA have not been established for peritoneovenous shunt scintigraphy in pediatric patients.
8.5Geriatric Use No formal studies of DRAXIMAGE MAA in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. In general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with Technetium Tc 99m Albumin Aggregated Injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted Radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. The radiation exposure to the fetus from technetium Tc 99m albumin aggregated is expected to be low (less than 0.5 mGy) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
🧒 Pediatric Use ▾
8.4Pediatric Use DRAXIMAGE MAA, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). The safety profile of Technetium Tc 99m Albumin Aggregated Injection in pediatric patients is similar to adults. The safety and efficacy of DRAXIMAGE MAA have not been established for peritoneovenous shunt scintigraphy in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No formal studies of DRAXIMAGE MAA in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. In general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Following intravenous injection, more than 80% of the technetium Tc 99m albumin aggregated particles is trapped in the pulmonary alveolar capillary bed within 5 minutes. Following intraperitoneal injection, 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.
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of technetium Tc 99m albumin aggregated have not been fully characterized.
12.3Pharmacokinetics Distribution Organ selectivity is a direct result of particle size. Albumin aggregated from 1 micrometer to 10 micrometers size are taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates become lodged in the lung by trapping in the pulmonary alveolar capillary bed.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Distribution of particles in the lungs is a function of regional pulmonary blood flow. The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be temporary.
Erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. The fragments are then accumulated by the reticuloendothelial system. Elimination Elimination of the technetium Tc 99m albumin aggregated particles from the lungs occurs with a half-life of about 2 to 3 hours.
Cumulative urinary excretion studies show an average of 20% elimination of the injected technetium Tc 99m albumin aggregated dose in 24 hours post-administration.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Following intravenous injection, more than 80% of the technetium Tc 99m albumin aggregated particles is trapped in the pulmonary alveolar capillary bed within 5 minutes. Following intraperitoneal injection, 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection contains 2.5 mg of albumin aggregated as a white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection. It contains no preservative. DRAXIMAGE MAA is supplied in a carton (NDC 65174-270-30) containing 30 multiple-dose reaction vials (NDC 65174-270-01) and 30 radioassay information labels.
Storage and Handling Before radiolabeling, store the supplied reaction vials at 2 ºC to 25ºC (36 ºF to 77 ºF). 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 ºC to 8 ºC (36 ºF to 46 ºF) when not in use. Use within 12 hours after radiolabeling [see Dosage and Administration (2.5)].
Dispose unused Technetium Tc 99m Albumin Aggregated Injection in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
📋 Description ▾
11 DESCRIPTION
11.1Product Characteristics DRAXIMAGE MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by denaturation of albumin human in a heating and aggregation process. Each vial contains 3,000,000 to 8,000,000 particles.
By light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers. DRAXIMAGE MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder supplied in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use.
Each reaction vial contains 2.5 mg of albumin aggregated, albumin human (5 mg), stannous chloride (0.06 mg minimum; 0.11 mg maximum stannous and stannic chloride) and sodium chloride (1.2 mg). Sodium hydroxide or hydrochloric acid has been added for pH adjustment. The pH is 5.2 to 6.
It contains no preservative.
11.2Physical Characteristics Technetium-99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 5. Table 5. Principal Radiation Emission Data for Technetium-99m Radiation Mean % per Disintegration Mean Energy (keV) Gamma 89.07 140.5
11.3 External Radiation The specific gamma ray constant for technetium-99m is
0.78R/mCi-hr at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 6.
For example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1,000. Table 6. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 7.
Table 7. Physical Decay Chart for Technetium-99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 5 0.562 1 0.891 6 0.501 2 0.794 8 0.398 3 0.708 10 0.316 4 0.631 12 0.251 *Calibration time
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their imaging and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Aggregated Albumin Injection, in order to reduce radiation exposure [see Dosage and Administration (2.2)]. Pregnancy Advise pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionucleotide procedure [see Use in Specific Populations (8.1)].
Lactation Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for at least 24hours after Technetium Tc 99m Albumin Aggregated Injection administration to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2)]. Manufactured by: Jubilant DraxImage Inc. 16 751 TransCanada Highway Kirkland, Quebec H9H 4J4 Canada 1-888-633-5343 US License Number: 2186 Rev.
Art: 4.0 412575 DRAXIMAGE ® is a registered trademark of Jubilant DraxImage Inc.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Distribution Organ selectivity is a direct result of particle size. Albumin aggregated from 1 micrometer to 10 micrometers size are taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates become lodged in the lung by trapping in the pulmonary alveolar capillary bed.
Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Distribution of particles in the lungs is a function of regional pulmonary blood flow. The albumin aggregated is sufficiently fragile for the capillary micro-occlusion to be temporary.
Erosion and fragmentation reduce the particle size, allowing passage of the aggregates through the pulmonary alveolar capillary bed. The fragments are then accumulated by the reticuloendothelial system. Elimination Elimination of the technetium Tc 99m albumin aggregated particles from the lungs occurs with a half-life of about 2 to 3 hours.
Cumulative urinary excretion studies show an average of 20% elimination of the injected technetium Tc 99m albumin aggregated dose in 24 hours post-administration.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of technetium Tc 99m albumin aggregated have not been fully characterized.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic potential or whether technetium Tc 99m albumin aggregated affects fertility in males or females.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic potential or whether technetium Tc 99m albumin aggregated affects fertility in males or females.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL MAA VIAL LABEL (INNER LABEL) MAA CARTON MAA POST-RECONSTITUTION LABEL Container label MAA MAA Carton Label MAA-Radiation Label
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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