Pulmotech MAA

PULMOTECH MAA- albumin aggregated injection, powder, lyophilized, for suspension
Curium US LLC

1 INDICATIONS AND USAGE

Technetium Tc 99m Albumin Aggregated Injection is a radioactive diagnostic agent indicated for:

• Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
• Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Administration

Adult Patients

The recommended intravenous dose range for adult patients for lung imaging is 37 MBq to 148 MBq (1 mCi to 4 mCi) and 200,000 to 700,000 particles of Technetium Tc 99m Albumin Aggregated Injection after preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection.

The recommended intraperitoneal dosage range for adult patients for peritoneovenous shunt patency evaluation is 37 MBq to 111 MBq (1 mCi to 3 mCi) and 200,000 to 700,000 particles. 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 recommended percutaneous transtubal dosage range for adult patients is 12 MBq to 37 MBq (0.3 mCi to 1 mCi) in a volume not to exceed 0.5 mL.

The recommended range of particle numbers per single injection is 200,000 to 700,000 with the recommended number of 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 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 Tc 99m that has occurred. The number of particles in any dose and volume to be administrated may be calculated as follows:

Where:

V_Tc = 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)

V_a = 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 (Table 7)

N = number of particles per vial. The number of particles per vial for the lot is located on the vial label.

Pediatric Patients

In pediatric patients, the recommended intravenous dose for perfusion lung imaging is in the range of 0.925 MBq/kg to 1.85 MBq/kg (0.025 mCi/kg to 0.05 mCi/kg) of body weight; a usual dose is 1.11 MBq/kg (0.03 mCi/kg), except in newborns, in whom the administered dose should be 7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi). Not less than the minimum dose of 7.4 MBq (0.2 mCi) should be employed for this procedure. The number of particles varies with age and weight as shown in Table 1.

Table 1 – Pediatric Patients: Particle Number and Dose for Lung Scintigraphy

Age	Newborn		1 year		5 years		10 years		15 years
Weight (kg)	3.5		12.1		20.3		33.5		55
Maximal recommended dose	MBq	mCi	MBq	mCi	MBq	mCi	MBq	mCi	MBq	mCi
	18.5	0.5	22.2	0.6	37	1	62.9	1.7	103.6	2.8
Range of particles	10,000 to		50,000 to		200,000 to		200,000 to		200,000 to
administered	50,000		150,000		300,000		300,000		700,000

Adults and Pediatric Patients

Visually inspect for particulate matter and discoloration prior to administration.

Measure the patient dose by a suitable radioactivity calibration system immediately prior to administration. Mix the contents of the vial by gentle inversion just prior to withdrawing 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 optimal results and because of rapid lung clearance of the radiopharmaceutical, position the patient 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.

2.2 Radiation Dosimetry

Adult Patients

The estimated absorbed radiation doses³ to an average adult patient (70 kg) from an intravenous administration of 148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated Injection are shown in Table 2.

Table 2 – Adults: Radiation Absorbed Doses for Lung Scintigraphy

Organs	mGy/148 MBq	rad/4 mCi
Total body	0.6	0.06
Lungs	8.8	0.88
Liver	0.72	0.072
Spleen	0.68	0.068
Kidneys	0.44	0.044
Bladder wall
3.5 hr. void	1.2	0.12
4.8 hr. void	2.2	0.22
Testes
3.5 hr. void	0.24	0.024
4.8 hr. void	0.26	0.026
Ovaries
3.5 hr. void	0.3	0.03
4.8 hr. void	0.34	0.034

Table 3 shows the radiation absorbed dose resulting from the intraperitoneal administration of 111 MBq (3 mCi) of Technetium Tc 99m Albumin Aggregated.

Table 3 – Adults: Radiation Absorbed Doses¹ for Intraperitoneal Shunt Scintigraphy

Organs	Shunt Patency		Shunt Patency
	(Open)		(Closed)
	mGy	Rad	mGy	Rad
Lung	6.9	0.69	1.68	0.168
Ovaries & Testes	0.18 to 0.3	0.018 to 0.03	1.68	0.168
Organs in the peritoneal cavity	–	–	1.68	0.168
Total body	0.36	0.036	0.57	0.057

Assumptions: calculations for the radiation absorbed dose are based upon an effective half-time of 3 hours for the open shunt and a physical half-life of 6 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance.

Pediatric Patients

In pediatric patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq (0.05 mCi) per kilogram of body weight (except in the newborns where the maximum recommended dose of 18.5 MBq (0.5 mCi) is used) and are shown in Table 4.

Table 4 – Pediatric Patients: Radiation Absorbed Doses for Lung Scintigraphy^2,3

Age	Newborn		1 year		5 years		10 years		15 years
	mGy	rad	mGy	Rad	mGy	rad	mGy	rad	mGy	Rad
ORGANS
Total body	0.6	0.06	0.3	0.03	0.31	0.031	0.48	0.048	0.41	0.041
Lungs	19	1.9	6.6	0.66	5.8	0.58	8.7	0.87	7.7	0.77
Liver	1.4	0.14	0.6	0.06	0.62	0.062	1.8	0.18	1.2	0.12
Bladder wall	2.1	0.21(1)	1.5	0.15(1)	3.1	0.31(2)	3.9	0.39(2)	4.1	0.41
Ovaries	0.38	0.038	0.2	0.02	0.19	0.019	0.44	0.044	0.41	0.041
Testes	0.31	0.031	0.13	0.013	0.19	0.019	0.2	0.02	0.36	0.036

⁽¹⁾ 2 hour voiding interval
⁽²⁾ 4.8 hour voiding interval