Draximage Maa
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
The 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.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5.0 mg of Albumin Human, 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH adjustment. No bacteriostatic preservative is present.
The Albumin Human 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). The aggregated particles are formed by denaturation of Albumin Human in a heating and aggregation process. Each vial contains 4 to 8 million 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.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final dosage form when sterile isotonic sodium pertechnetate solution is added to each vial. No less than 90% of the pertechnetate Tc-99m added to a reaction vial is bound to aggregate at preparation time and remains bound throughout the 6 hour lifetime of the preparation.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1
Table 1. Principal Radiation Emission Data
| 1 Kocher, David C.; “Radioactive Decay Data Tables’’, DOE/TIC-11026, 108, (1981) |
||
| Radiation |
Mean %/Disintegration |
Mean Energy (keV) |
| Gamma-2 |
89.07 |
140.5 |
® Registered Trademark of Jubilant DraxImage Inc.
EXTERNAL RADIATION
The specific gamma ray constant for Tc 99m is 0.78 R/mCi-hr at 1 cm. The first half value layer is 0.017 cm of lead. A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 2. For example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1000.
Table 2. Radiation Attenuation by Lead (Pb) Shielding
| Shield Thickness (Pb) cm |
Coefficient of Attenuation |
| 0.017 0.08 0.16 0.25 0.33 |
0.5 10-1 10-2 10-3 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 3.
Table 3
Physical Decay Chart :Tc-99m half-life 6.02 hours
| * Calibration Time | |||
| Hours |
Fraction Remaining |
Hours |
Fraction Remaining |
| 0* 1 2 3 4 |
1.000 0.891 0.794 0.708 0.631 |
5 6 8 10 12 |
0.562 0.501 0.398 0.316 0.251 |
Sources
Draximage Maa Manufacturers
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Jubilant Draximage Inc.
![Draximage Maa (Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated) Injection, Powder, For Solution [Jubilant Draximage Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Draximage Maa | Jubilant Draximage Inc.
The recommended intravenous dose range for the average (70 kg) ADULT patient for lung imaging is 37 to 148 megabecquerels (1-4 millicuries) of Technetium Tc 99m Albumin Aggregated Injection after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection.
The suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneovenous (LeVeen) shunt patency evaluation is 37 to 111 megabecquerels (1 to 3 millicuries). Adequate measures should be taken to assure uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with other clinical findings. Alternatively, the drug may be administered by percutaneous transtubal injection. The suggested percutaneous transtubal (efferent limb) dosage range for the average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0 millicurie) in a volume not to exceed 0.5 mL.
The recommended number of particles per single injection is 200 000 to 700 000 with the suggested number being approximately 350 000. Depending on the activity added and volume of the final reconstituted product, the volume of the dose may vary from 0.2 to 1.4 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 Tc- 99m that has occurred. The number of particles in any dose and volume to be administered may be calculated as follows:
Assume the average number of particles per vial = 6.0 x 106.
If:
VTc = volume of solution added to reaction vial
D = desired dose to be administered in MBq (mCi)
C = concentration at calibration time of sodium pertechnetate solution to be added to the reaction vial in MBq/mL (mCi/mL)
Va = volume to be administered in mL
P = number of particles in dose to be administered
Fr = fraction of technetium Tc-99m remaining after the time of calibration (see Table 3)
Then:
Va = D and P = Va x 6.0 x 106
C x Fr VTcIn PEDIATRIC patients, the suggested intravenous dose to be employed for perfusion lung imaging is in the range of 0.925 to 1.85 MBq per kilogram (25 to 50 μCi/kg) of body weight; a usual dose is 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in whom the administered dose should be 7.4 to 18.5 MBq (200 to 500 μCi). Not less than the minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The number of particles will vary with age and weight of the pediatric patient as indicated in Table 5.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Mix the contents of the vial by gentle inversion just prior to with drawing a patient dose.
Mix the contents of the syringe just before injection. If blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation. For optimum results and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the patient be positioned under the imaging apparatus before administration. Slow injection is recommended. Lung imaging may begin immediately after intravenous injection of the radiopharmaceutical. Due to high kidney uptake, imaging later than one-half hour after administration will yield poor results.RADIATION DOSIMETRY
The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an intravenous injection of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated Injection are shown in Table 4.
Table 4
2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
Absorbed Radiation DosesOrgans
mGy/148 MBq
rads/4 mCi
Total body
Lungs
Liver
Spleen
Kidneys
Bladder Wall
2.0 hr. void
4.8 hr. void
Testes
2.0 hr. void
4.8 hr. void
Ovaries
2.0 hr. void
4.8 hr. void
0.60
8.8
0.72
0.68
0.44
1.2
2.2
0.24
0.26
0.30
0.34
0.060
0.88
0.072
0.068
0.044
0.12
0.22
0.024
0.026
0.030
0.034
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight [except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi) is used] and are shown in Table 5, which lists the maximum dose for pediatric patients from newborn to adults. Note the recommendations regarding number of particles to be administered.
Table 6 represents the absorbed radiation dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of technetium Tc 99m albumin aggregated.
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