Albumin aggregated

FDA label, Curium US LLC, intraperitoneal, effective 2025-10-13. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Due to high kidney uptake, imaging later than one-half hour after administration is not recommended. For peritoneovenous shunt imaging, obtain serial images of both the shunt and target organ. 2.7 Radiation Dosimetry Intravenous Administration Estimated radiation absorbed doses from intravenous administration are shown in Table 2. [See table below.] *--: Not available Intraperitoneal Administration Estimated radiation absorbed doses from intraperitoneal administration are shown in Table 3. [See table below.] *--: Not available

Preparation and administration

Prepare this dose

Your numbers for albumin aggregated. Take vial strength, diluent, and limits from the label below.

Basis

Enter a dose to see draw volume, final concentration, and rates.

Patient 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] . 2. 3 Recommended 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 range of particle numbers per single injection should be 200,000 to 700,000 with the recommended number of 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 technetium-99m that has occurred.

The number of particles in any dose and volume to be administrated may be calculated as follows: 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) Fr = fraction of Technetium-99m remaining after the time of calibration from Table 6 [see Description] 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 the lot is located on the vial label. 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

Radiation Dosimetry Intravenous Administration Estimated radiation absorbed doses from intravenous administration are shown in Table 2. [See table below.] *--: Not available Intraperitoneal Administration Estimated radiation absorbed doses from intraperitoneal administration are shown in Table 3. [See table below.] *--: Not available

Contraindications

4 CONTRAINDICATIONS PULMOTECH 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 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for albumin aggregated. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection use are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted. Although all 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 0.50 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 defect, 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 is 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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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