DRAXIMAGE MAA

DRAXIMAGE MAA — albumin aggregated injection, powder, for solution
Jubilant DraxImage Inc., dba Jubilant Radiopharma

DRAXIMAGE® M AA

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 mg of human serum albumin , 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 human serum albumin was non-reactive when tested for Hepatitis B Surface Antigen (HBs Ag), 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 the albumin in a heating and aggregation process. Each vial contains 3 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 a sterile isotonic sodium pertechnetate solution is added to the 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 usage lifetime of the preparation (See Directions For Preparation).

PHYSICAL CHARACTERISTICS

Technetium Tc-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 1.

Table 1 — Principal Radiation Emission Data

Radiation

Mean %/Disintegration

Mean Energy (keV)

Gamma

89.07

140.5

EXTERNAL RADIATION

The specific gamma ray constant for technetium 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 1,000.

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

CLINICAL PHARMACOLOGY

Immediately following intravenous injection, more than 80% of the albumin aggregated is trapped in the pulmonary alveolar capillary bed. The imaging procedure can thus be started as soon as the injection is complete. Assuming that a sufficient number of radioactive particles has been used, the distribution of radioactive aggregated particles in the normally perfused lung is uniform throughout the vascular bed, and will produce a uniform image. Areas of reduced perfusion will be revealed by a corresponding decreased accumulation of the radioactive particles, and are imaged as areas of reduced photon density.

Organ selectivity is a direct result of particle size. Below 1 to 10 micrometers, the material is taken up by the reticuloendothelial system. Above 10 micrometers, the aggregates become lodged in the lung by a purely mechanical process. 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.

Lung to liver ratios greater than 20:1 are obtained in the first few minutes post-injection. Elimination of the Technetium Tc 99m Aggregated Albumin 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 dose 24 hours post-administration.

Following administration of Technetium Tc 99m Albumin Aggregated by intraperitoneal injection, the radiopharmaceutical 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.

Serial images should be obtained of both the shunt and lung (target organ). However, an adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases.

INDICATIONS AND USAGE

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.

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.

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