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PULMOCIS KIT FOR PREPARATION OF TECHNETIUM HUMAN ALBUMIN MACROAGGREGATES INJECTION

Active substance(s): HUMAN ALBUMIN MACROAGGREGATES / HUMAN ALBUMIN MACROAGGREGATES / HUMAN ALBUMIN MACROAGGREGATES

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SUMMARY OF PRODUCT CHARACTERISTICS
1.

NAME OF THE MEDICINAL PRODUCT

PULMOCIS 2 mg kit for radiopharmaceutical preparation.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 2 mg of human albumin as macroaggregates.
The radionuclide is not part of the kit.
The macroaggregates number per vial is ranging between 2 and 4 millions.
No macroaggregates has a size higher than 150 µm.
Not more than 10 of them have a size higher than 100µm.
Excipient(s) with known effect:
Each vial contains 3.5 mg of sodium.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Kit for radiopharmaceutical preparation
White pellet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (99mTc) solution, the suspension of
technetium(99mTc) -albumin macroaggregates (or 99mTc-MAA) obtained is indicated for:
Pulmonary perfusion scintigraphy.
As secondary indication 99mTc-albumin macroaggregates may be used for venoscintigraphy.

4.2

Posology and method of administration

This medicinal product is intended for use in designated nuclear medicine facilities only, and
should only be handled by authorised personnel.
Posology
Adults
The recommended activity administered to an adult weighing 70 kg varies between 37 and 185 MBq,
The number of particles per administered dose must be in a range of 60 x 103 - 700 x 103.

Paediatric population
The use in children and adolescents has to be considered carefully, based upon clinical needs and
assessing the risk/benefit ratio in this patient group. The activities to be administered to children and to
adolescents should be a fraction of the adult activity and should be calculated according to the
following equation:

Although body weight is the more used factor on which to base the adjustment of the activity
administered, in a limited number of cases the body surface area may be considered to be more
appropriate.

Method of administration
Multidose use.
This medicinal product should be reconstituted before administration to the patient.
The radiolabelled solution must be administered by slow intravenous injection.
For instructions on extemporaneous preparation of the medicinal product before
administration, see section 12.
For patient preparation, see section 4.4.
Image acquisition
The lung test can be started immediately after injection.
In pulmonary scintigraphy, images can be acquired in anterior, right/left oblique, right/left
profile and posterior position.
4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to any of the
components of the labelled radiopharmaceutical.

4.4

Special warnings and precautions for use

Potential for hypersensitivity or anaphylactic reactions
The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid
reactions should always be considered. If hypersensitivity or anaphylactic reactions occur, the
administration of the medicinal product must be discontinued immediately and intravenous treatment
initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products
and equipment such as endotracheal tube and ventilator must be immediately available.

Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should in every case be as low as reasonably achievable to obtain the
required diagnostic information.

In patients with significant right to left cardiac shunt, or with respiratory failure complicating
pulmonary hypertension, special care should be exercised when administering 99mTc albumin
macroaggregates (MAA). In order to minimise the possibility of microembolism to the
cerebral and renal circulations 99mTc-MAA should be given by slow intravenous injection and
the number of particles reduced by up 50%.
Paediatric population
For information on the use in paediatric population, see sections 4.2.
Careful consideration of the indication is required since the effective dose per MBq is higher
than in adults (see section 11).
Patient preparation
The patient should be well hydrated before the start of the examination and urged to void as
often as possible during the first hours after the examination in order to reduce radiation.
Specific warnings
PULMOCIS contains human albumin.
Standard measures for preventing transmission of infections from pharmaceuticals made of
human blood or plasma, include selection of donators, test of individual donators and plasma
pools for finding specific infective agents, and effective manufacturing steps for
inactivation/elimination of virus as a part of manufacturing process as well. In spite of that,
the risk of transmission of infectious agents cannot be eliminated completely, as long as
pharmaceuticals made of human blood or plasma are used. This also applies to new virus of
unknown nature and other pathogens as well.
There are no reports of virus transmission in connection with albumin, made in accordance
with specifications in Ph. Eur. and in accordance with routine processes.
It is strongly recommended that the product name and batch number are stated every time
Pulmocis is given to a patient, in order to maintain a connection between the patient and the
product’s batch number.
The syringe should be gently swirled immediately prior to the injection to homogenise the injectate.
Blood should never be drawn into the syringe because that induces the formation of small clots.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree’.

Precautions with respect to environmental hazard see section 6.6.
4.5

Interaction with other medicinal products and other forms of interaction

Changes in the biological distribution of 99mTc-MAA may be induced by different drugs.
Pharmacologic interactions may be caused by chemotherapeutic agents, heparin and
bronchodilators.
Toxicological interactions may be caused by heroin, nitrofurantoin, busulfan,
cyclophosphamide, bleomycin, methotrexate, methysergide.
-

Pharmaceutical interactions may be caused by magnesium sulphate.

4.6

Fertility, pregnancy and lactation

Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of childbearing potential is
intended, it is important to determine whether or not she is pregnant. Any woman who has
missed a period should be assumed to be pregnant until proven otherwise. If in doubt about
her potential pregnancy (if the woman has missed a period, if the period is very irregular,
etc.), alternative techniques not using ionising radiation (if there are any) should be offered to
the patient.
Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit
far exceeds the risk incurred by the mother and the foetus.

Breast feeding:
Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be
given to the possibility of delaying the administration of radionuclide until the mother has ceased
breastfeeding, and to what is the most appropriate choice of radiopharmaceutical has been made,
bearing in mind the secretion of radioactivity in breast milk. If the administration is considered
necessary, breast feeding should be interrupted for 12 hours and the expressed feeds discarded.

4.7

Effects on ability to drive and use machines

No studies on the effects on ability to drive and use machines have been performed.
4.8

Undesirable effects

For safety with respect to transmissible agents see section 4.4.
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare
(≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the
available data)

Immune system disorders
Frequency not known: Hypersensitivity-type reactions, including life-threatening anaphylaxis.
Application site hypersensitivity.
Single or repeated injections of 99mTc-albumin macroaggregates may be associated with
hypersensitive-type reactions including very rare life-threatening anaphylaxis, with chest pain, rigor
and collapse. Local allergic reactions have been seen at the injection site.
Exposure to ionising radiation is linked with cancer induction and a potential for development of
hereditary defects.

As the effective dose is 2.0 mSv when the maximal recommended activity of 185 MBq is
administered these adverse reactions are expected to occur with a low probability.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard.

4.9

Overdose

The number of MAA particles per adult patient must not exceed 1.5 x 106.

In the event of the administration of a radiation overdose with 99mTc-MAA, the absorbed dose
to the patient should be reduced where possible by increasing the elimination of the
radionuclide from the body by forced diuresis and frequent bladder voiding.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceuticals, ATC code: V09EB01
Pharmacodynamic effects
At the chemical concentrations used for diagnostic examinations, 99mTc-MAA does not appear
to have any pharmacodynamic activity.
5.2

Pharmacokinetic properties

Distribution
Following injection into a superficial vein of the systemic venous circulation, the macroaggregates are
carried at the speed of this circulation to the first capillary filter, i.e. the capillary tree of the pulmonary
artery system.

Organ uptake
The albumin macroaggregate particles do not penetrate the lung parenchyma (interstitial or alveolar)
but remain in a temporary occlusive position in the lumen of the capillary. When pulmonary flow

distribution is normal, the compound distributes over the entire pulmonary area following physiologic
gradients; when district flow is altered the areas of reduced flow are reached by a proportionally
smaller amount of particles. The technetium labelled macroaggregates remain in the lungs for variable
periods of time, depending of the structure, size and number of particles.

Half-life
The disappearance of activity from the particles in the lungs is governed by a exponential law: the
larger aggregate have a longer biological half-life, whereas particles between 5 and 90 μm in diameter
have a half-life ranging from 2 to 8 hours.
The decrease in pulmonary concentration is caused by the mechanical break-down of the particles
occluding the capillaries, stemming from the systo-diastolic pressure pulsations within the capillary
itself.

Elimination
The products of macroaggregate break-down, once recirculated as albumin microcolloid, are quickly
removed by the macrophages of the reticuloendothelial system, i.e. essentially the liver and the spleen.
The microcolloid is metabolised with introduction of the radioactive label (99mTc) into the systemic
circulation from which it is removed and excreted in urine.

5.3

Preclinical safety data

Correlation exists between the size of the MAA and their toxic effects.
The pathophysiologic mechanism responsible for toxicity is shown to be the increase of the pulmonary
blood pressure.

Toxicological studies with dogs have demonstrated that with a single IV injection of 20 to
25 mg/kg of MAA having 10 to 50 µm in diameter the first pulmonary signs of toxicity (e.g.
tachypnea) were observed.
A sharp increase of the pulmonary blood pressure is noticed when 20 mg of less than 80 μm sized
MAA are injected, where no significant pressure changes are recorded with 40 mg of less than 35 μm
MAA particles.
With suspension of MAA up to 150 μm diameter, no blood pressure changes appear below 10 mg/kg,
while larger diameter suspensions (up to 300 μm) typical blood pressure changes in pulmonary artery
appear when the dose exceeds 5 mg/kg.
The repeated-dose toxicity studies performed in dogs show no detectable variations in the general
behaviour of the animals.
No evidence of pathological changes in the main organs has been detected.

Mutagenicity studies, toxicity to reproduction and development studies and long-term
carcinogenicity studies have not been carried out. There is no evidence in the literature of
teratogenic, mutagenic or carcinogenic effect of the unlabelled product.
This medicinal product is not intended for regular or continuous administration.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

Human albumin
Stannous chloride dihydrate
Sodium chloride
Under nitrogen atmosphere

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Human albumin
Stannous chloride dihydrate
Sodium chloride

6.2

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other
medicinal products except those mentioned in section 12.

6.3

Shelf life

1 year.

After radiolabelling: store in a refrigerator (2 °C – 8 °C). and use within 8 hours.
6.4

Special precautions for storage

Store the kit in a refrigerator (2 °C – 8 °C).
For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive
materials.

6.5

Nature and contents of container

15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with rubber stoppers and
aluminium capsules.

Pack size: 5 multidose vials.

6.6

Special precautions for disposal

General warning
Radiopharmaceuticals should be received, used and administered only by authorised persons
in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to
the regulations and/or appropriate licences of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety
and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
Contents of the vials are intended only for use in the preparation of 99mTc-MAA and are not to
be administered directly to the patient without first undergoing the preparative procedure.
For instructions on extemporaneous preparation of the medicinal product before
administration, see sections 12.
If at any time in the preparation of this product the integrity of this vial is compromised it
should not be used.
Administration procedures should be carried out in a way to minimise risk of contamination
of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.
The content of the kit before extemporaneous preparation is not radioactive. However, after
sodium pertechnetate (99mTc), Ph. Eur. is added, adequate shielding of the final preparation
must be maintained.
The administration of radiopharmaceuticals creates risks for other persons from external
radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions
in accordance with national regulations must therefore be taken.
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.

7

MARKETING AUTHORISATION HOLDER

CIS bio international
RN306, Saclay
B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 11876/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

Date of first authorisation: 15 July 1996
Date of latest renewal: 11 June 2010

10

DATE OF REVISION OF THE TEXT
25/11/2015

11

DOSIMETRY

Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the
emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to
technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as
quasi stable.
The data listed below are from ICRP 80:
DOSE ABSORBED PER ACTIVITY ADMINISTERED (mGy / MBq)
Organ

Adult

15 year old

10 year old

5 year old

1 year old

Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI-tract
Stomach
SI
Colon
(ULI
(LLI
Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas
Red marrow
Skin
Spleen
Testes
Thymus
Thyroid
Uterus
Remaining
organs
Effective dose
(mSv/MBq)

0.0068
0.0087
0.0051
0.00092
0.005
0.0056

0.0088
0.011
0.0064
0.0012
0.0056
0.007

0.013
0.014
0.0091
0.002
0.0099
0.01

0.019E
0.016
0.014
0.0032
0.014
0.016

0.031
0.030
0.026
0.0055
0.021
0.024

0.0037
0.002
0.0019
0.0022
0.0016
0.0096
0.0037
0.016
0.066
0.0028
0.0061
0.0018
0.0056
0.0032
0.0015
0.0041
0.0011
0.0061
0.0025
0.0022
0.0028

0.0052
0.0026
0.0026
0.0029
0.0021
0.013
0.0048
0.021
0.097
0.0037
0.0077
0.0023
0.0075
0.0038
0.0017
0.0055
0.0014
0.0077
0.0033
0.0028
0.0036

0.008
0.0043
0.0043
0.005
0.0033
0.018
0.0072
0.03
0.13
0.0052
0.011
0.0035
0.011
0.0053
0.0027
0.0083
0.0022
0.011
0.0057
0.0042
0.005

0.012
0.0068
0.0069
0.0083
0.005
0.025
0.011
0.042
0.21
0.0077
0.015
0.0054
0.017
0.0072
0.0043
0.013
0.0033
0.015
0.009
0.006
0.0074

0.02
0.012
0.012
0.014
0.0095
0.038
0.018
0.074
0.39
0.014
0.022
0.01
0.029
0.012
0.0078
0.022
0.0062
0.022
0.016
0.011
0.013

0.011

0.016

0.023

0.034

0.063

The effective dose resulting from the administration of an activity of 185 MBq of 99mTc-MAA
for an adult weighing 70 kg is about 2.0 mSv.
For an administered activity of 185 MBq the typical radiation dose to the target organ, lungs,
is 12.2 mGy and the typical radiation dose to the critical organs, adrenals, bladder, liver,
pancreas, spleen, are 1.26, 1.61, 2.96, 1.04 and 0.76 mGy respectively.

12
INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
Usual precautions regarding sterility and radioprotection must be respected.
Withdrawals should be performed under aseptic conditions.
The vial must not be opened and must be kept inside the lead shielding. After disinfection of
the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted
with suitable protective shielding and a disposable sterile needle or using an authorised
automated application system.
If the integrity of this vial is compromised, the product should not be used.
Method of preparation
Usual precautions regarding sterility and radioprotection should be respected.
Take a vial from the kit and put it in an appropriate lead shielding.
Using a hypodermic syringe, introduce through the rubber stopper 2.5 to 10 ml of sterile and pyrogenfree sodium pertechnetate [99mTc] injection, radioactivity varying as a function of the volume from
92.5 to maximum 3700 MBq.
Sodium pertechnetate [99mTc] injection should comply with European Pharmacopoeia specifications.
Do not use a breather needle as the contents is under nitrogen : after introduction of the volume of
sodium pertechnetate [99mTc] injection, without removing the needle, withdraw an equivalent volume
of nitrogen in order to avoid excess pressure in the vial.
Shake for about 2 minutes and wait for 15 minutes before use.
The vial should be shaked before each withdrawal in order to homogenise the suspension.
The syringe should be swirled immediately prior to injection to homogenise the injectate.
The homogeneousness of the suspension after preparation, pH, radioactivity and gamma spectrum
should be checked before use.
The vial should never be opened and must be kept inside its lead shielding. The suspension should be
removed aseptically through the stopper with a sterile lead protected syringe.
Determination of volume and activity of pertechnetate in relation with the number of MAA particles
per dose.
In order to take into account the number of MAA particles per dose in the determination of volume
and radioactivity of pertechnetate to prepare the radiopharmaceutical, charts have been performed and
are described hereafter.

The proposed figures in the following tables are calculated from a mean value of 3 millions of MAA
particles per vial.
The first step allows to determine the volume of labelling of the vial as a function of the
volume and the number of MAA particles to inject per dose. The used formula is as follows:

The tables 1 and 2 show examples for volumes to inject of 0.5, 0.8 and 1 ml.
The second step allows to know the radioactivity to add in the vial for the labelling as a
function of the radioactivity to inject and the previously set parameters.The used formula is as follows:

The total radioactivity of the vial is calculated for radioactivities to inject of 37, 74, 111 and 148 MBq.
See tables 3, 4, 5 and 6.
The third step will describe the decrease calculation taking into account the time of labelling
and the time of injection. The decay table of 99mTc is presented in table 7.

TABLE 1

DETERMINATION OF THE LABELLING VOLUME
FROM VOLUME AND NUMBER OF MAA PARTICLES TO INJECT
AND CONSIDERING A VIAL CONTAINING 3 MILLIONS MAA PARTICLES

VOLUME TO INJECT (ml)

NUMBER OF MAA PARTICLES
TO INJECT PER DOSE

0.5

0.8

1

600 000

2.5

4

5

500 000

3

4.8

6

480 000

3.1

5

6.3

428 000

3.5

5.6

7

400 000

3.75

6

7.5

375 000

4

6.4

8

343 000

4.4

7

8.7

330 000

4.5

7.3

9

300 000

5

8

10

267 000

5.6

9

250 000

6

9.6

240 000

6.25

10

215 000

7

188 000

8

167 000

9

150 000

10

Labelling volume (ml)
Injected volume (ml)
Number of MAA particles to inject / dose

TABLE 2

DETERMINATION OF THE NUMBER OF INJECTED MAA PARTICLES AS A
FUNCTION OF THE LABELLING VOLUME OF THE VIAL AND THE VOLUME
TO INJECT AND CONSIDERING A VIAL CONTAINING 3 MILLIONS MAA
PARTICLES

VOLUME TO INJECT (ml)
VOLUME OF LABELLING (ml)

0.5

3

500 000

4

375 000

600 000

5

300 000

480 000

600 000

6

250 000

400 000

500 000

7

215 000

343 000

428 000

8

188 000

300 000

375 000

9

167 000

267 000

330 000

10

150 000

240 000

300 000

Labelling volume (mL)
Injected volume (mL)
Number of MAA particles to inject/dose

0.8

1

TABLES 3, 4, 5 and 6
DETERMINATION OF THE RADIOACTIVITY TO ADD TO THE VIAL AS A FUNCTION OF
THE LABELLING VOLUME, THE VOLUME AND THE RADIOACTIVITY TO INJECT
AND CONSIDERING A VIAL CONTAINING 3 MILLIONS MAA PARTICLES
74 MBq

37 MBq

0.5

0.8

1

0.5

0.8

3

222

139

111

444

4

296

185

148

592

370

5

370

231

185

740

462

6

444

277

222

888

7

518

324

259

8

592

370

9

666

10

740

111 MBq

1

0.5

0.8

1

666

0.5

0.8

1

888

888

555

370

1110

694

555

444

1332

1036

647

518

296

1184

740

416

333

1332

462

370

1480

Table 3

148 MBq

1184

740

555

1480

925

740

832

666

1776

1110

888

1554

980

777

2072

1295

1036

592

1776

1110

888

2368

1480

1184

832

666

1998

1249

999

2664

1665

1332

925

740

2220

1387

1110

2960

1850

1480

Table 4

Table 5

Injected activity (MBq)

Injected volume (ml)

Total activity (MBq)

Labelling volume (ml)

Table 6

TABLE 7
99m

H Min

%

H Min

Tc (HALF-LIFE : 6.02 hours) DECAY TABLE
%
H Min
%
H Min
%
H Min

%

H Min

0 05

99.05 2 05

78.67

4 05 62.49

6 05

49.64

8 05

39.43

10 05

31.32

0 10

98.10 2 10

77.92

4 10 61.89

6 10

49.16

8 10

39.05

10 10

31.02

0 15

97.16 2 15

77.18

4 15 61.30

6 15

48.69

8 15

38.68

10 15

30.72

0 20

96.23 2 20

76.44

4 20 60.72

6 20

48.23

8 20

38.61

10 20

30.43

0 25

95.32 2 25

75.71

4 25 60.14

6 25

47.77

8 25

37.94

10 25

30.14

0 30

94.41 2 30

74.99

4 30 59.56

6 30

47.31

8 30

37.58

10 30

29.85

0 35

93.50 2 35

74.27

4 35 58.99

6 35

46.86

8 35

37.22

10 35

29.57

0 40

92.61 2 40

73.56

4 40 58.43

6 40

46.41

8 40

36.87

10 40

29.28

0 45

91.73 2 45

72.86

4 45 57.87

6 45

45.97

8 45

36.51

10 45

29.00

0 50

90.85 2 50

72.16

4 50 57.32

6 50

45.53

8 50

36.17

10 50

28.73

0 55

89.98 2 55

71.47

4 55 56.77

6 55

45.10

8 55

35.82

10 55

28.45

1 00

89.12 3 00

70.79

5 00 56.23

7 00

44.66

9 00

35.48

11 00

28.18

1 05

88.27 3 05

70.12

5 05 55.69

7 05

44.24

9 05

35.14

11 05

27.91

1 10

87.43 3 10

69.45

5 10 55.16

7 10

43.82

9 10

34.80

11 10

27.64

1 15

86.60 3 15

68.78

5 15 54.64

7 15

43.40

9 15

34.47

11 15

27.38

1 20

85.77 3 20

68.13 5 20 54.11

7 20

42.98

9 20

34.14

11 20

27.12

1 25

84.95 3 25

67.48

5 25 53.60

7 25

42.57

9 25

33.82

11 25

26.86

1 30

84.14 3 30

66.83

5 30 53.09

7 30

42.17

9 30

33.49

11 30

26.60

1 35

83.33 3 35

66.19

5 35 52.58

7 35

41.76

9 35

33.17

11 35

26.35

1 40

82.54 3 40

65.56

5 40 52.08

7 40

41.36

9 40

32.86

11 40

26.10

1 45

81.75 3 45

64.94

5 45 51.58

7 45

40.97

9 45

32.54

11 45

25.85

1 50

80.97 3 50

64.32

5 50 51.09

7 50

40.58

9 50

32.23

11 50

25.60

1 55

80.20 3 55

63.70

5 55 50.60

7 55

40.19

9 55

31.92

11 55

25.36

2 00

79.43 4 00

63.09

6 00 50.12

8 00

39.81

10 00

31.62

12 00

25.12

%

EXAMPLE FOR AN INJECTED VOLUME OF 1 ml
The following table and curve allow to determine the number of MAA particles injected when
volumes of labelling are 5 to 10 ml and when the volume to inject is 1 ml.
The proposed figures in the following tables are calculated from a mean value of 3 millions of MAA
particles per vial.

Number of injected MAA particles (thousand)

The formula used is:

Volume of labelling (ml)

Number of injected MAA particles

5

600 000

6

500 000

7

428 600

8

375 000

9

333 300

10

300 000

700
600
500
400
300
200
100
0
5

6

7

8

Labelling volume (ml)

9

10

The following table and graph allow deducing the total radioactivity to add to the vial
when the radioactivities to inject are 74, 111 or 148 MBq with a injected volume of 1 ml and
considering a vial containing 3 millions particles.

Total radioactivity per vial (MBq) with a radioactivity to inject of
Volume of
labelling (ml)

74 MBq

111 MBq

148 MBq

5

370

555

740

6

444

666

888

7

518

777

1036

8

592

888

1184

9

666

999

1332

10

740

1110

1480

Total radioactivity per vial (MBq)

1500
1400
1300
1200
1100
1000
900
800
700
600
500
400
300
5

6

7

8

9

Labelling volume (ml)
Injected radioactivity = 74 MBq (2 mCi)
Injected radioactivity = 148 MBq (4 mCi)

Injected radioactivity = 111 MBq (3 mCi)

10

Quality control
The quality of labelling (radiochemical purity) could be checked according to the following procedure
:
Method
Non-filterable radioactivity.
Materials and methods
1.
Polycarbonate membrane filter 13 mm to 25 mm in diameter, 10 µm thick and with circular
pores 3 µm in diameter.
2.
0.9 % sodium chloride solution.
3.
Miscellaneous : syringes, needles, 15 ml glass vials, appropriate counting assembly.
Procedure
1.
Fit the membrane into a suitable holder.
2.
Place 1 ml of the injection on the membrane, filter and collect in a vial (A).
3.
Rinse the membrane with 2 ml of 0.9% sodium chloride solution and collect in the vial (A).
4.
Measure the radioactivity of the filter (X) and the radioactivity of the vial A (Y), using an
appropriate detection apparatus.
5.
Calculations :
Calculate the percentage of technetium [99mTc] human albumin macroaggregates as follows :

The radioactivity remaining on the membrane should be not less than 90 % of the total radioactivity of
the injection.

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

Detailed information on this medicinal product is available on the website of the MHRA.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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