Consumer medicine information

Draximage MAA

Technetium(99mTc) macrosalb

BRAND INFORMATION

Brand name

Draximage MAA

Active ingredient

Technetium(99mTc) macrosalb

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Draximage MAA.

What is in this leaflet?

This leaflet answers some common questions about DRAXIMAGE® MAA. It does not contain all the available information, nor does it take the place of talking to your doctor or treatment provider.

All medicines and diagnostic preparations have risks and benefits. Your doctor has weighed the risks of you receiving DRAXIMAGE® MAA against the expected benefits.

If you have any concerns about being given DRAXIMAGE® MAA, ask your doctor or treatment provider.

Keep this leaflet. You may need to refer to it again.

What DRAXIMAGE® MAA is used for

DRAXIMAGE® MAA is for diagnostic use only.

It is used in the preparation of a radiopharmaceutical, which is a medicinal product containing a small amount of radioactivity.

Such radiopharmaceuticals are given in small amounts to find or rule out a disease. The radiation your body receives is very low and is considered safe. After the radioactive liquid is given to you, it is taken up by the organs of interest or just passes through your body. The radiation is captured by a special camera and pictures are prepared. These pictures allow the nuclear medicine doctor to detect any problems.

DRAXIMAGE® MAA can be used for lung scans. These scans provide information about the structure of the lungs and the blood flow through the lung tissue.

DRAXIMAGE® MAA can also be used to show how the blood flows through the veins.

Your doctor will tell you which specific investigation DRAXIMAGE® MAA will be used for in your case.

Before you are given DRAXIMAGE® MAA

When you must not be given DRAXIMAGE® MAA

Do not use DRAXIMAGE® MAA if you are allergic (hypersensitive) to macroaggregated human albumin or any of the ingredients of DRAXIMAGE® MAA listed at the end of this leaflet, or if you have severe pulmonary hypertension (unusually high blood pressure in the arteries of the lungs). The literature contains reports of deaths after the administration of aggregated albumin to patients with pre-existing severe pulmonary hypertension. In case of doubt, it is important to consult your doctor.

Before you are given DRAXIMAGE® MAA

Your doctor must know about all of the following before you are given DRAXIMAGE® MAA. Tell your doctor if you:

  1. Are pregnant:
The use of radiopharmaceuticals during pregnancy should be considered carefully. Your doctor will only administer this product during pregnancy if a benefit is expected which should outweigh the risks.
  1. Are breastfeeding:
Your doctor may advise you to interrupt breastfeeding after the procedure for a period of at least 12 hours and to discard expressed milk during that time. Breastfeeding may be resumed after the prescribed period.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your doctor or treatment provider has more information on medicines to be careful with or to avoid when you are given DRAXIMAGE® MAA.

If you have not told your doctor about any of the above, tell them before you are given any DRAXIMAGE® MAA.

About blood products

This product contains albumin, a derivative of human blood. When medicines are made from human blood or plasma, measures are put in place to prevent infection transmission. Despite this, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

How DRAXIMAGE® MAA is given

Your doctor may have special instructions for you to follow to get ready for your procedure.

DRAXIMAGE® MAA is given as an injection into a vein.

DRAXIMAGE® MAA must only be given by a doctor or nuclear medicine technologist. Your doctor is qualified in nuclear medicine and will decide what dose of DRAXIMAGE® MAA you will receive, depending on your condition. The amount of radioactivity you will receive can vary from 37 to 148 MBq (Mega Becquerel, the unit used to express radioactivity).

DRAXIMAGE® MAA is usually given as a single dose and, within minutes after it is given, diagnostic images will be taken.

If you have any questions about taking DRAXIMAGE® MAA or about the diagnostic procedure, ask your doctor.

After being given DRAXIMAGE® MAA

Your doctor may advise you to drink a lot to help the traces of radioactivity leave your body more quickly. This is normal when using diagnostic radiopharmaceuticals. Your doctor will also tell you about any other steps you may need to take following the use of this product.

Do not hesitate to consult your doctor if you are not sure.

Side Effects

Like all medicines, DRAXIMAGE® MAA may cause side effects, although not everybody gets them. Most people have no side effects.

A very small number of patients have experienced allergic reactions such as urticaria (hives or red raised itchy bumps on the skin), nausea and reddening of the face. Local injection site reactions in the form of redness, swelling and itching have also been observed.

Other side effects may include fever, shivering, seizures, sweating, as well as impairments of cardiorespiratory and circulatory functions in the form of changes in respiration, pulse, low blood pressure and fainting.

Importantly, if any side effects gets serious or when in doubt, seek prompt medical attention. If treated immediately, reactions were short-lived.

If you notice side effects not listed in this leaflet, it is important that you speak to your doctor or pharmacist.

Overdose

The dose of DRAXIMAGE® MAA you will receive will be calculated by a qualified nuclear medicine doctor and given to you in a highly specialized setting. Therefore the possibility of overdose is minimal.

Storage

DRAXIMAGE® MAA will be stored by the hospital or clinic. The hospital or clinic will make sure that DRAXIMAGE® MAA is not used if the expiry date printed on the pack has passed.

Further information

This is not all information that is available on DRAXIMAGE® MAA. If you have any more questions or are not sure about anything, ask your doctor or nuclear medicine technologist.

Product description

What it looks like

DRAXIMAGE® MAA is a white powder. It comes in a 10 mL glass vial.

Ingredients

The active substance is a natural protein from human blood: macroaggregated human albumin.

Each reaction vial contains:

  • 2.5 mg of albumin aggregated
  • 5.0 mg of albumin human
  • 0.1 mg of stannous chloride dehydrate
  • 1.2 mg of sodium chloride

Australian Registration Number

AUST R 261212

Sponsor

DRAXIMAGE® MAA is manufactured by:

Jubilant DraxImage Inc.
16751 TransCanada Highway, Kirkland, Quebec, H9H 4J4 Canada

DRAXIMAGE® MAA is distributed in Australia by:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
53-59 Oatley Court
Belconnen, Australia Capital Territory 2617
Australia
+61 2 6251 6533

This leaflet was prepared in September 2016.

DRAXIMAGE® is a Registered Trademark of Jubilant DraxImage Inc.

Published by MIMS January 2018

BRAND INFORMATION

Brand name

Draximage MAA

Active ingredient

Technetium(99mTc) macrosalb

Schedule

Unscheduled

 

Name of the medicine

Kit for the preparation of technetium Tc 99m albumin aggregated injection.
Each 10 mL reaction vial contains 5.0 mg of albumin human, 0.1 mg of stannous chloride dihydrate and 1.2 mg of sodium chloride under an atmosphere of nitrogen. Sodium hydroxide and/or hydrochloric acid is used for pH adjustment.

Description

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, 0.1 mg of stannous chloride dihydrate and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. Sodium hydroxide and/or hydrochloric acid is used for pH adjustment prior to lyophilization so that the pH of the reconstituted radiopharmaceutical is 5.2 to 6.0.
No bacteriostatic preservative is present.
The human serum albumin 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 human 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 sterile isotonic sodium pertechnetate solution is added to each vial. Not less than 90% of the pertechnetate Tc 99m added to a reaction vial is bound to aggregates at preparation time and remains bound throughout the 8-hour lifetime of the preparation.

Physical characteristics.

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.

External radiation.

The specific gamma ray constant for technetium-99m is 5.44 microC.kg-1.MBq-1.hr-1 (0.78 R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of lead. To facilitate control of the radiation exposure from megabecquerel amounts of this radionuclide, the use of a 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1,000. 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.
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.

Pharmacology

Immediately following intravenous injection, more than 80% of the aggregated albumin 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 mononuclear phagocyte 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 aggregated albumin is sufficiently fragile for 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 mononuclear phagocyte 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 indicate an average of 20% elimination of the injected technetium Tc 99m dose within 24 hours after administration.

Indications

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 paediatric 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.

Precautions

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 also been reported.

General.

The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.
In patients with right to left heart shunts, additional risk may exist due to the rapid entry of aggregated albumin into the systemic circulation. The safety of this agent in such patients has not been established.
Hypersensitivity reactions are possible whenever protein-containing materials such as pertechnetate-labelled aggregated albumin are used in man. Epinephrine, antihistamines, and corticosteroids should be available for immediate use.
The intravenous administration of any particulate materials such as aggregated albumin imposes a small temporary mechanical impediment to blood flow. While this effect is probably physiologically insignificant in most patients, the administration of aggregated albumin is possibly hazardous in acute cor pulmonale and other states of severely impaired pulmonary blood flow.
The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
Contents of the vials are intended only for use in the preparation of Technetium Tc 99m Albumin Aggregated Injection and are not to be administered directly to the patient.
The technetium Tc 99m labelling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.
The preparation contains no bacteriostatic preservative. Technetium Tc 99m Albumin Aggregated Injection should be stored at 2°C to 8°C and discarded 8 hours after reconstitution.
Technetium Tc 99m Albumin Aggregated Injection is physically unstable and consequently the particles settle with time. Failure to agitate the vial adequately before use may result in non-uniform distribution of radioactive particles.
If blood is drawn into the syringe, any unnecessary delay prior to injection may result in clot formation in situ.
Do not use if clumping of the contents is observed.
Technetium Tc 99m Albumin Aggregated Injection, as well as other radioactive drugs must be handled with care. Once sodium pertechnetate Tc 99m is added to the vial, appropriate safety measures must be used to minimize radiation exposure to clinical personnel. Care must also be taken to minimize the radiation exposure to patients in a manner consistent with proper patient management.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Effects on fertility.

No long term animal studies have been performed to evaluate whether Technetium Tc 99m Albumin Aggregated Injection affects fertility in males or females.

Genotoxicity and carcinogenicity.

No studies have been performed to evaluate the genotoxic or carcinogenic potential of Technetium Tc 99m Albumin Aggregated Injection.

Use in pregnancy.

(Category C)
Since adequate reproduction studies with technetium Tc 99m Albumin Aggregated Injection have not been performed in animals to determine whether this drug affects fertility in males and females, has teratogenic potential or has other adverse effects on the foetus, this radiopharmaceutical preparation should not be administered to pregnant or nursing women unless it is considered that the benefits to be gained outweigh the potential hazards to the foetus and safer alternative procedures are not available.
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists it is important that radiation exposure should be minimum consistent with achieving the desired clinical information. Alternative techniques which do not involve ionising radiation should be considered.

Use in lactation.

Technetium-99m is excreted in human milk. Interruption to breast feeding is necessary after the administration of Technetium Tc 99m Albumin Aggregated Injection for a period of at least 12 h.

Paediatric use.

The lowest possible number of particles should be used in right-to-left shunting, in neonates, and in severe pulmonary disease.

Pathogen safety.

This product contains albumin, a derivative of human blood. When medicines are made from human blood or plasma, measures are put in place to prevent infection transmission. Despite this, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

Adverse Effects

The literature contains reports of deaths occurring after the administration of aggregated albumin 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 (See Precautions).

Dosage and Administration

Radiation dosimetry.

The estimated absorbed radiation doses2 to various organs of 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.
In paediatric patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq/kg (50 microCi/kg) of body weight (except in the newborn where the maximum recommended dose 18.5 MBq [500 microCi] is used) and are shown in Table 5, which lists the maximum dose for paediatric patients from newborn to adults. Note the recommendations regarding the number of particles to be administered.

Adult patients.

The recommended intravenous dose range for the average (70 kg) adult patient is 37 to 148 MBq (1 to 4 mCi) of Technetium Tc 99m Albumin Aggregated Injection after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection. The suggested range of particle numbers for a single injection is 200,000 to 700,000 with the recommended 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 1.9 mL.
The number of particles is to be reduced between 100,000 and 200,000 for patients with severe cardiovascular disease, with pulmonary hypertension accompanied by respiratory insufficiency or with right-to-left shunt.

Elderly patients.

The dose for elderly is unknown. However, they have generally been treated with a similar dose as adult patients.

Paediatric patients.

In paediatric patients, the suggested intravenous dose to be employed for perfusion lung imaging is in the range of 0.925 MBq to 1.85 MBq per kilogram (25 to 50 microCi/kg) of body weight; a usual dose is 1.11 MBq per kilogram (30 microCi/kg), except in newborns, in whom the administered dose should be 7.4 MBq to 18.5 MBq (200 to 500 microCi). Not less than the minimum dose of 7.4 MBq (200 microCi) should be employed for this procedure. The number of particles will vary with age and weight of the paediatric patient as indicated in Table 5.
The number of particles available per millicurie dose of technetium Tc 99m will vary depending on the physical decay of the technetium that has occurred. The number of particles available in any dose and volume to be administered may be calculated by means of the following formulas:
Using proper shielding, parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration.
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 withdrawing a patient dose.
Gently 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. Slow injection is recommended. For optimum results and because of rapid lung clearance, it is suggested that the patient be positioned under the imaging apparatus before administration. 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.

Directions for preparation.

The preparation of Technetium Tc 99m Albumin Aggregated Injection may be accomplished by the following procedure. Use aseptic procedure throughout and take precautions to minimize radiation exposure by the use of suitable shielding. Waterproof gloves should be worn during the preparation procedure.
Before reconstituting a vial it should be inspected for cracks and/or a melted plug or any other indication that the integrity of the vacuum seal has been lost.
It is anticipated that any Tc 99m generator approved in Australia would be suitable as a source of sodium pertechnetate Tc 99m, however, complete data is not available to confirm this. Global Medical Solutions should be contacted for any available information.
The Tc 99m pertechnetate eluate should be less than 2 hours old and should be obtained from a generator which has been eluted within the last 24 hours.
To prepare Technetium Tc 99m Albumin Aggregated Injection:
1. Remove the protective disc from the reaction vial and swab the closure with an alcohol swab.
2. Place the vial in a suitable lead vial shield which has a minimum wall thickness of 3 mm (1/8 inch) and a fitted lead cap. Obtain 2 to 8 mL of sterile, non-pyrogenic sodium pertechnetate Tc 99m using a shielded syringe.
The recommended maximum amount of technetium Tc 99m (at the time of elution) to be added to a reaction vial is 5.18 gigabecquerels (140 mCi). Sodium pertechnetate Tc 99m solutions containing an oxidizing agent are not suitable for use.
3. Using a shielded syringe, aseptically add the sodium pertechnetate Tc 99m solution to the reaction vial, while avoiding the build up of excessive pressure in the vial. Pressure build up may be avoided by injecting several milliliters of pertechnetate solution into the reaction vial, then withdrawing several milliliters of nitrogen gas (present to prevent oxidation of the complex) into the syringe. The procedure is repeated as necessary until the entire amount of pertechnetate is added to the vial and normal pressure is established within the vial.
4. Place the lead cap on the vial shield and mix the contents of the shielded vial by repeated gentle inversion until all the material is suspended. Avoid the formation of foam. Using proper shielding, the vial should be visually inspected to ensure that the suspension is free of foreign matter before proceeding; if it is not, the radiopharmaceutical should not be used. To ensure maximum radiolabelling, allow the preparation to stand for 15 minutes after mixing at 2°C to 8°C.
5. Assay the product in a suitable calibrator, record the radioassay information on the label which has a radiation warning symbol. Also note the time and date of preparation. Apply the label to the vial shield.
6. The radiochemical purity of the finished preparation should be determined prior to patient administration. The radiochemical purity should not be less than 90%.
7. Withdrawals for administration must be made aseptically using a sterile needle (18 to 21 gauge) and syringe. Since the vials contain nitrogen, the vials should not be vented. If repeated withdrawals are made, the replacement of the contents of the vial with air should be minimized and separate syringes must be used for each patient.
8. The finished preparation should be discarded after 8 hours. It should also be retained during its life in a lead vial shield with the lead cap in place.

Radiochemical purity.

Chromatographic methods.

The following procedure describes a series of simple steps for running chromatograms.
Steps 1 to 6 describe the method for determining free pertechnetate in a mixture of chelated and reduced technetium. The TLC procedure requires the following:
Solid phase: ITLC-SG.
Solvent: Acetone (for determination of pertechnetate).

Step 1.

Add 1 mL of the required solvent to an 18 mm x 150 mm test tube. Stopper and allow the atmosphere in the tube to equilibrate for 1 minute.

Step 2.

Place a drop (approximately 0.02 mL) of the radioactive solution on a 1 cm x 10 cm chromatographic strip at a pencil mark 1 cm from one end of the strip, which is the origin. A simple way to do this is to use a standard 1 mL tuberculin syringe with a 25 gauge needle and dispense one small drop. Discard the needle and syringe after use. Instead of a tuberculin syringe a 20 microliter disposable micropipette can also be used to dispense 0.02 mL.
Immediately dry the spot using a gentle stream of nitrogen gas. Do not use compressed air since this tends to cause pertechnetate formation.

Step 3.

Develop the chromatogram by placing it, with the origin down into the solvent, in the previously equilibrated test tube. Stopper the test tube. The test tube should be kept upright, ideally in a test tube rack. Development requires about 10 minutes for ITLC-SG strips.

Step 4.

When the solvent front has climbed to the top of the strip, remove it with forceps and allow it to dry. The strips can be dried by placing them radioactive side up on a disposable non-porous pad at room temperature.
The bound and reduced fractions stay at the origin while free pertechnetate TcO4- migrates to the front Rf 0.85 to 1.0.

Step 5.

Cut the dried strip 2 cm from the solvent front end. The short piece is marked Part II and the long piece is marked Part I. Count the pieces in a suitable counter and determine the percentage of free pertechnetate according to the following formula:

Step 6.

Store all waste radioactive strips for 48 hours before disposing of them as non-radioactive waste. Store used chromatographic solvents in a similar fashion.

Presentation

Draximage MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection.
The lyophilised product is available in a carton containing 10 reaction vials, labels with radiation warning symbol and a package insert.
Each 10 mL, Type I glass reaction vial contains sterile and non-pyrogenic (see Table 6):
The vials are sealed under an atmosphere of nitrogen.

Storage

The unreconstituted reaction vials should be stored at 2°C to 25°C. After labelling with technetium Tc 99m, the radiopharmaceutical should be stored at 2°C to 8°C.

Expiry.

The finished preparation should be discarded 8 hours after reconstitution. Do not use the kit beyond the expiry date stamped on the box.

References

1. Kocher David C., “Radioactive Decay Data Tables”, DOE/TIC-11026, 108 (1981).
2. Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
3. Kaul A., Oeff K., Roedler H.D. and Vogelsang T., Die Strahlenbelastung von Patienten bei der Nucklearmedizinischen Anwendung Offener Radioaktiver Stoffe. Informationsdienst fur Nuklearmedizin. Klinikum Steglitz der Freien Universitat 1000 Berlin 45, Hindenburgdamm 30, Herausgerber : Prof. Dr. Med. Karl Oeff, Berlin, 1973.
4. Henrichs K., Kaul A. and Krause M., Altersabhangige Werte der Spezifischen Organdosis. Klinikum Steglitz, Physik und Strahlenschutz (Biophysik), Freie Universitat Berlin, Berlin, 1980.
5. Parker J.A., Coleman R.E., Grady E., Royal H.D., Siegel B.A., Stabin M.G., Sostman H.D., Hilson A.J., Society of Nuclear Medicine. SNM practice guideline for lung scintigraphy 4.0. J Nucl Med Technol. 2012.
6. Bajc M., Neilly J.B., Miniati M., Schuemichen C., Meignan M., Jonson B., EANM Committee. EANM guidelines for ventilation/perfusion scintigraphy: Part 1. Pulmonary imaging with ventilation/perfusion single photon emission tomography. Eur J Nucl Med Mol Imaging 2009; 36(8):1356.
7. Stabin M.G.1, Breitz H.B., Breast milk excretion of radiopharmaceuticals: mechanisms, findings, and radiation dosimetry. J Nucl Med. 2000 May; 41(5):863-73.
8. Cranage R., Palmer M., Breast-milk radioactivity after 99mTc-MAA lung studies. Eur J Nucl Med. 1985; 11(6-7):257-9.
9. Howe D.B., Beardsley M., Bakhsh S.R., Office of Federal and State Materials and Environmental Management Programs U.S. Nuclear Regulatory Commission Washington, DC. Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses. NUREG - 14556 2008; 9(2).

Poison Schedule

Unscheduled.