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TECHNESCAN MIBI 1MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): TETRAKIS COPPER TETRAFLUOROBORATE

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DRN 4376

Technescan Sestamibi United Kingdom

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Technescan MIBI 1 mg, kit for radiopharmaceutical preparation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg [Tetrakis(2-methoxy-2-methylpropyl-1
isocyanide)copper(I)] tetrafluoroborate.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White to almost white pellets or powder.
To be reconstituted with sodium pertechnetate (99mTc) solution for
injection.
4.

CLINICAL PARTICULARS

4.1 Therapeutic indications
This medicinal product is for diagnostic use only. This is indicated for
adults. For paediatric population see section 4.2.
After radiolabelling with sodium pertechnetate (99mTc) solution, the
solution of technetium (99mTc) sestamibi obtained is indicated for:
Myocardial perfusion scintigraphy
for the detection and localisation of coronary artery disease
(angina pectoris and myocardial infarction)
Assessment of global ventricular function
First-pass technique for determination of ejection fraction and/or
ECG-triggered, gated SPECT for evaluation of left ventricular
ejection fraction, volumes and regional wall motion.
Scintimammography for the detection of suspected breast cancer
when mammography is equivocal, inadequate or indeterminate.
Localisation of hyperfunctioning parathyroid tissue in patients with
recurrent or persistent disease in both primary and secondary
hyperparathyroidism, and in patients with primary
hyperparathyroidism scheduled to undergo initial surgery of the
parathyroid glands.
4.2 Posology and method of administration
Posology
Adults and elderly population
Posology may vary depending on gamma camera characteristics and
reconstruction modalities. The injection of activities greater than local
DRLs (Diagnostic Reference Levels) should be justified.
The recommended activity range for intravenous administration to an
adult patient of average weight (70 kg) is for:
Diagnosis of reduced coronary perfusion and myocardial infarction
400 – 900 MBq
The recommended activity range for diagnosis of ischaemic heart
disease according to the European procedural guideline is

Two-day protocol: 600–900 MBq/study

One-day protocol: 400–500 MBq for the first injection, three times
more for the second injection.
Not more than a total of 2000 MBq should be administered for a one-day
protocol and 1800 MBq for a two-day-protocol. For a one day protocol,
the two injections (stress and rest) should be done at least two hours
apart but may be performed in either order. After the stress injection,
exercise should be encouraged for an additional one minute (if possible).
For diagnosis of myocardial infarction one injection at rest is usually
sufficient.
For diagnosis of ischaemic heart disease two injections (stress and rest)
are required in order to differentiate transiently from persistently reduced
myocardial uptake.
Assessment of global ventricular function
600 – 800 MBq injected as a bolus.
Scintimammography
700 – 1000 MBq injected as a bolus usually in the arm opposite to the
lesion.

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 1 of 6

Localisation of hyperfunctioning parathyroid tissue
200 - 700 MBq injected as a bolus. The typical activity is between
500 – 700 MBq.
Posology may vary depending on gamma camera characteristics and
reconstruction modalities.
The injection of activities greater than local DRLs (Diagnostic Reference
Levels) should be justified.
Renal impairment
Careful consideration of the activity to be administered is required since
an increased radiation exposure is possible in these patients.
Hepatic impairment
In general, activity selection for patients with a decreased hepatic
function should be cautious, usually starting at the low end of the dosing
range.
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
adolescents may be calculated according to the recommendations of the
European Association of Nuclear Medicine (EANM) paediatric dosage
card; the activity administered to children and to adolescents may be
calculated by multiplying a baseline activity (for calculation purposes) by
the weight-dependent multiplies given in the table below.
A[MBq]Administered = Baseline Activity × Multiple
The baseline activity is 63 MBq as a cancer seeking agent. For cardiac
imaging, the minimum and maximum baseline activities are
42 and 63 MBq, respectively, for the two-day protocol cardiac scan both
at rest and stress. For the one-day cardiac imaging protocol, the
baseline activity is 28 MBq at rest and 84 MBq at stress. The minimum
activity for any imaging study is 80 MBq.
Weight
[kg]
3
4
6
8
10
12
14
16
18
20

Multiple
1
1.14
1.71
2.14
2.71
3.14
3.57
4.00
4.43
4.86

Weight
[kg]
22
24
26
28
30
32
34
36
38
40

Multiple
5.29
5.71
6.14
6.43
6.86
7.29
7.72
8.00
8.43
8.86

Weight
[kg]
42
44
46
48
50
52-54
56-58
60-62
64-66
68

Multiple
9.14
9.57
10.00
10.29
10.71
11.29
12.00
12.71
13.43
14.00

Method of administration
For intravenous use.
Because of potential tissue damage, extravasal injection of this
radioactive product has to be strictly avoided.
For multidose use.
Precautions to be taken before handling or administration of the
medicinal product
This medicinal product should be reconstituted before administration to
the patient. For instructions on reconstitution and control of the
radiochemical purity of the medicinal product before administration, see
section 12.
For patient preparation, see section 4.4.
Image acquisition
Cardiac Imaging
Imaging should begin approximately after 30 - 60 min after injection to
allow for hepatobiliary clearance. Longer delay can be required for
resting images and for stress with vasodilatators alone because of the
risk of higher subdiaphragmatic technetium (99mTc) activity. There is no
evidence for significant changes in myocardial tracer concentration or
redistribution, therefore imaging for up to 6 hours post injection is
possible. Test may be done in a one day or two days protocol.
Preferably tomographic imaging (SPECT) with or without ECG gating
should be performed.
Scintimammography
Breast imaging is optimally initiated 5 to 10 minutes post injection with
the patient in the prone position with breast freely pendant.
The product is administered in an arm vein contralateral to the breast
with the suspected abnormality. If the disease is bilateral, the injection is
ideally administered in a dorsal vein of the foot.

DRN 4376

Technescan Sestamibi United Kingdom

Conventional gamma camera
The patient should then be repositioned so that the contralateral breast
is pendant and a lateral image of it should be obtained. An anterior
supine image may then be obtained with the patient’s arms behind her
head.
Detector dedicated to breast imaging
In case a detector dedicated to breast imaging is used, a relevant
machine-specific protocol must be followed to obtain the best possible
imaging performance.
Parathyroid imaging
Parathyroid image acquisition depends on the protocol chosen. The
most used studies are either the subtraction and/or the dual-phase
techniques, which can be performed together.
For the subtraction technique either sodium iodide (123I) or sodium
pertechnetate (99mTc) can be used for imaging for the thyroid gland since
these radiopharmaceuticals are trapped by functioning thyroid tissue.
This image is subtracted from the technetium (99mTc) sestamibi image,
and pathological hyperfunctioning parathyroid tissue remains visible after
subtraction. When sodium iodide (123I) is used, 10 to 20 MBq are orally
administered. Four hours after the administration, neck and thorax
images may be obtained. After sodium iodide (123I) image acquisition,
200 to 700 MBq of technetium (99mTc) sestamibi are injected and images
are acquired 10 minutes post injection in double acquisition with 2 peaks
of gamma energy (140 keV for technetium (99mTc) and 159 keV for
iodine (123I). When sodium pertechnetate (99mTc) is used,
40-150 MBq are injected and neck and thorax images are acquired
30 minutes later. Then 200 to 700 MBq of technetium (99mTc) sestamibi
are injected and a second acquisition of images is acquired 10 minutes
later.
If the dual phase technique is used, 400 to 700 MBq of technetium
(99mTc) sestamibi are injected and the first neck and mediastinum image
is obtained 10 minutes later. After a wash-out period of 1 to 2 hours,
neck and mediastinum imaging is again performed.
The planar images may be complemented by early and delayed SPECT
or SPECT/CT.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed
in section 6.1.
In myocardial scintigraphy investigations under stress conditions, the
general contraindications associated with the induction of ergometric or
pharmacological stress should be considered.
4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
If hypersensitivity or anaphylactic reactions occurs, 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.
Renal or hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required
since an increased radiation exposure is possible (see section 4.2).
Paediatric population
For information on the use in paediatric population, see section 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.
Cardiac imaging
If possible, patients should fast for at least four hours prior to the study. It
is recommended that patients eat a light fatty meal or drink a glass or
two of milk after each injection, prior to imaging. This will promote rapid
hepatobiliary clearance of technetium (99mTc) sestamibi resulting in less
liver activity in the image.

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 2 of 6

Interpretation of technetium (99mTc) sestamibi images
Interpretation of scintimammography
Breast lesions less than 1 cm in diameter may not all be detected with
scintimammography as the sensitivity of technetium (99mTc) sestamibi for
the detection of these lesions is low. A negative examination does not
exclude breast cancer especially in such a small lesion.
After the procedure
Close contact with infants and pregnant women should be restricted
during the initial 24 hours following the injection.
Specific warnings
In myocardial scintigraphy investigations under stress conditions, the
general contraindications and precautions associated with the induction
of ergometric or pharmacological stress should be considered.
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially ‘sodium- free’.
For precautions with respect to environmental hazard see section 6.6.
4.5

Interaction with other medicinal products and other forms of
interaction
Medicinal products which affect myocardial function and/or blood flow
may cause false negative results in the diagnosis of coronary arterial
disease. Particularly beta-blockers and calcium antagonists reduce
oxygen consumption and thus also affect perfusion and beta-blockers
inhibit the increase of heart frequency and blood pressure under stress.
For this reason, concomitant medication should be taken into
consideration when interpreting the results of the scintigraphic
examination. The recommendations of the applicable guidelines on
ergometric or pharmacological stress tests should be followed.
When the subtraction technique is used for imaging of hyperfunctioning
parathyroid tissue, recent use of iodine containing radiologic contrast
media, medicinal products used to treat hyper- or hypothyroidism or of
several other medicinal products is likely to decrease the quality of
thyroid imaging and even makes subtraction impossible. For a complete
list of possibly interacting medicinal products refer to the SmPCs of
sodium iodide (123I) or sodium pertechnetate (99mTc).
Paediatric population
Interaction studies have only been performed in adults.
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 dose 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 foetus.
Breastfeeding
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
radiopharmaceuticals, bearing in mind the secretion of activity in breast
milk. If the administration is considered necessary, breastfeeding should
be interrupted for 24 hours and the expressed feeds discarded.
Close contact with infants should be restricted during the initial 24 hours
following injection.
Fertility
No studies on fertility have been performed.
4.7 Effects on ability to drive and use machines
Technescan MIBI has no or negligible influence on the ability to drive
and use machines.

DRN 4376

Technescan Sestamibi United Kingdom

4.8 Undesirable effects
The following table presents how the frequencies are reflected in this
section:
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)
Not known (cannot be estimated from the available data)
Immune system disorders:
Rare: Severe hypersensitivity reactions such as dyspnoea, hypotension,
bradycardia, asthenia and vomiting (usually within two hours of
administration), angioedema. Other hypersensitivity reactions (allergic
skin and mucosa reactions with exanthema (pruritus, urticaria, oedema),
vasodilatation).
Very rare: Other hypersensitivity reactions have been described in
predisposed patients.
Nervous system disorders:
Uncommon: Headache
Rare: Seizures (shortly after administration), syncope.

Page 3 of 6

Biodistribution
Technetium (99mTc) sestamibi from the blood is rapidly distributed into
the tissue: 5 minutes after injection only about 8% of the injected dose
remains in the blood pool. In physiological distribution, evident
concentration of technetium (99mTc) sestamibi can be seen in vivo in
several organs. In particular, normal tracer uptake is evident in the
salivary glands, thyroid, myocardium, liver, gallbladder, small and large
intestine, kidneys, bladder, choroid plexuses and skeletal muscles,
occasionally in the nipples. Faint homogeneous uptake in the breast or
axilla is normal.
Myocardial perfusion scintigraphy
Technetium (99mTc) sestamibi is a cationic complex which diffuses
passively through the capillary and cell membrane. Within the cell it is
localised in the mitochondria, where it is trapped, and retention is based
on intact mitochondria, reflecting viable myocytes. After intravenous
injection, it is distributed within the myocardium according to myocardial
perfusion and viability. Myocardial uptake which is coronary flow
dependent is 1.5% of the injected dose at stress and 1.2% of the
injected dose at rest. Irreversibly damaged cells however do not take up
technetium (99mTc) sestamibi. The myocardial extraction level is reduced
by hypoxia. It has very little redistribution and so separate injections are
required for stress and resting studies.

Gastrointestinal disorders:
Uncommon: Nausea
Rare: Abdominal pain.

Scintimammography
The tissue uptake of technetium (99mTc) sestamibi depends primarily on
the vascularisation which is generally increased in tumor tissue.
Technetium (99mTc) sestamibi accumulates in various neoplasms and
most markedly in mitochondria. Its uptake is related to increased energydependent metabolism and cell proliferation. Its cellular accumulation is
reduced when multidrug resistance proteins are overexpressed.

Skin and subcutaneous tissue disorders:
Rare: local reactions at the injection site, hypoaesthesia and
paraesthesia, flushing.
Not known: Erythema multiforme.

Parathyroid imaging of hyperfunctioning tissue
Technetium (99mTc) sestamibi localises in both parathyroid tissue and
functioning thyroid tissue but usually washes out of normal thyroid tissue
more rapidly than out of abnormal parathyroid tissue.

General disorders and administration site conditions
Common: Immediately after injection, a metallic or bitter taste, partly in
combination with dry mouth and an alteration in the sense of smell may
be observed.
Rare: Fever, fatigue, dizziness, transient arthritic-like pain, dyspepsia.

Elimination
Elimination of technetium (99mTc) sestamibi occurs mostly through the
kidneys and the hepatobiliary system.
Activity of technetium (99mTc) sestamibi from the gallbladder appears in
the intestine within one hour of injection. About 27% of the injected dose
is cleared through renal elimination after 24 hours and approximately
33% of the injected dose is cleared through the faeces in 48 hours. The
pharmacokinetics in patients with renal or hepatic impairment has not
been characterised.

Cardiac disorders
Uncommon: Chest pain/angina pectoris, abnormal ECG.
Rare: Arrhythmia.

Other disorders
Exposure to ionising radiation is linked with cancer induction and a
potential for development of hereditary defects. As the effective dose is
16.4 mSv when the maximal recommended activity of 2000 MBq (500 at
rest and 1500 MBq at stress) for a 1-day-protocol 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 the national
reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
In the event of administration of a radiation overdose with
technetium (99mTc) sestamibi the absorbed dose to the patient should be
reduced where possible by increasing the elimination of the radionuclide
from the body by frequent micturition and defaecation. It might be helpful
to estimate the effective dose that was applied.
5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals,
Technetium (99mTc) compounds, ATC code: V09GA01.
Pharmacodynamic effects
At the chemical concentrations used for diagnostic examinations,
technetium (99mTc) sestamibi solution does not appear to have any
pharmacodynamic activity.
5.2 Pharmacokinetic properties
After reconstitution with sodium pertechnetate (99mTc), the following
technetium (99mTc) sestamibi complex is formed:
[99mTc (MIBI)6]+
Where: MIBI = 2-methoxyisobutylisonitrile

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Half-Life
The biological myocardial half-life of technetium (99mTc) sestamibi is
approximately 7 hours at rest and stress. The effective half-life (which
includes biological and physical half-lives) is approximately 3 hours for
the heart and approximately 30 minutes for the liver.
5.3 Preclinical safety data
In acute intravenous toxicity studies in mice, rats and dogs, the lowest
dose of the reconstituted Sestamibi kit that resulted in any deaths was
7 mg/kg (expressed as Cu (MIBI)4 BF4 content) in female rats. This
corresponds to 500 times the maximal human dose (MHD) of
0.014 mg/kg for adults (70 kg). Neither rats nor dogs exhibited treatment
related effects at reconstituted Sestamibi kit doses of 0.42 mg/kg
(30 times MHD) and 0.07 mg/kg (5 times MHD) respectively for 28 days.
At repeated dose administration, the first toxicity symptoms appeared
during the administration of 150 times the daily dose during 28 days.
Extravasation administration in animals showed acute inflammation with
oedema and haemorrhages at the injected site.
Studies on reproductive toxicity have not been conducted.
Cu (MIBI)4 BF4 showed no genotoxic activity in the Ames, CHO/HPRT
and sister chromatid exchange tests. At cytotoxic concentrations, an
increase in chromosome aberration was observed in the in vitro human
lymphocyte assay. No genotoxic activity was observed in the in vivo
mouse micronucleus test at 9 mg/kg.
Studies to assess the carcinogenic potential of the radiopharmaceutical
kit have not been conducted.
6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Stannous chloride dihydrate
Cysteine hydrochloride monohydrate

DRN 4376

Technescan Sestamibi United Kingdom

Sodium citrate
Mannitol
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide(for pH-adjustment)

9.

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 12.

10. DATE OF REVISION OF THE TEXT
10/07/2014

6.3 Shelf life
2 years.
After radiolabelling: 10 hours. Do not store above 25°C after
radiolabelling.
6.4 Special precautions for storage
Do not store above 25°C. Keep the vials in the outer carton in order to
protect from light.
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
10 ml multi-dose glass vials, type 1 borosilicate glass (Ph. Eur.) sealed
with a chlorobutyl rubber stopper.
Pack size:
5 vials.
6.6 Special precautions for disposal and other handling
General warnings
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 vial are intended only for use in the preparation of
technetium (99mTc) sestamibi and are not to be administered directly to
the patient without first undergoing the preparative procedure.
For instructions on extemporary preparation of the medicinal product
before administration, see section 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 extemporary preparation is not radioactive.
However, after sodium pertechnetate (99mTc), 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 or any other biological fluids. 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 for radioactive materials.
7.
MARKETING AUTHORISATION HOLDER
Mallinckrodt Medical B.V.
Westerduinweg 3
1755 LE Petten,
The Netherlands
8.
MARKETING AUTHORISATION NUMBER(S)
PL 12288/0002

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 4 of 6

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 15/09/2008
Date of latest renewal: 08/05/2013

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 and are calculated according to
the following assumptions: After intravenous injection the substance is
rapidly cleared from the blood and taken up predominantly mainly in
muscular tissues (including heart), liver, and kidneys, with a smaller
amount in salivary glands and thyroid. When the substance is injected in
conjunction with a stress test, there is a considerable increase of the
uptake in heart and skeletal muscles, with a correspondingly lower
uptake in all other organs and tissues. The substance is excreted by the
liver and kidneys in the proportions 75% and 25%, respectively.
Absorbed dose per unit activity administered (mGy/MBq)
(Resting subject)
Organ
Adult
15-years 10-years 5-years
Adrenals
0.0075 0.0099
0.015
0.022
Bladder
0.011
0.014
0.019
0.023
Bone surfaces
0.0082 0.010
0.016
0.021
Brain
0.0052 0.0071
0.011
0.016
Breast
0.0038 0.0053
0.0071
0.011
Gall bladder
0.039
0.045
0.058
0.10
Gastrointestinal
tract:
Stomach
0.0065 0.0090
0.015
0.021
Small intestine
0.015
0.018
0.029
0.045
Colon
0.024
0.031
0.050
0.079
Upper large
0.027
0.035
0.057
0.089
intestine
Lower large
0.019
0.025
0.041
0.065
intestine
Heart
0.0063 0.0082
0.012
0.018
Kidneys
0.036
0.043
0.059
0.085
Liver
0.011
0.014
0.021
0.030
Lungs
0.0046 0.0064
0.0097
0.014
Muscles
0.0029 0.0037
0.0054
0.0076
Oesophagus
0.0041 0.0057
0.0086
0.013
Ovaries
0.0091 0.012
0.018
0.025
Pancreas
0.0077 0.010
0.016
0.024
Red marrow
0.0055 0.0071
0.011
0.030
Salivary glands
0.014
0.017
0.022
0.015
Skin
0.0031 0.0041
0.0064
0.0098
Spleen
0.0065 0.0086
0.014
0.020
Testes
0.0038 0.0050
0.0075
0.011
Thymus
0.0041 0.0057
0.0086
0.013
Thyroid
0.0053 0.0079
0.012
0.024
Uterus
0.0078 0.010
0.015
0.022
Remaining organs 0.0031 0.0039
0.0060
0.0088
Effective dose
(mSv/MBq)
0.0090 0.012
0.018
0.028

1-year
0.038
0.041
0.038
0.027
0.020
0.32
0.035
0.080
0.015
0.17
0.12
0.030
0.15
0.052
0.025
0.014
0.023
0.045
0.039
0.044
0.026
0.019
0.034
0.021
0.023
0.045
0.038
0.016
0.053

DRN 4376

Technescan Sestamibi United Kingdom

Absorbed dose per unit activity administered (mGy/MBq)
(Exercise)
Organ
Adult
15-years 10-years 5-years
Adrenals
0.0066 0.0087
0.013
0.019
Bladder
0.0098 0.013
0.017
0.021
Bone surfaces
0.0078 0.0097
0.014
0.020
Brain
0.0044 0.0060
0.0093
0.014
Breast
0.0034 0.0047
0.0062
0.0097
Gall bladder
0.033
0.038
0.049
0.086
Gastrointestinal
tract:
Stomach
0.0059 0.0081
0.013
0.019
Small intestine
0.012
0.015
0.024
0.037
Colon
0.019
0.025
0.041
0.064
Upper large
0.022
0.028
0.046
0.072
intestine
Lower large
0.016
0.021
0.034
0.053
intestine
Heart
0.0072 0.0094
0.010
0.021
Kidneys
0.026
0.032
0.044
0.063
Liver
0.0092 0.012
0.018
0.025
Lungs
0.0044 0.0060
0.0087
0.013
Muscles
0.0032 0.0041
0.0060
0.0090
Oesophagus
0.0040 0.0055
0.0080
0.012
Ovaries
0.0081 0.011
0.015
0.023
Pancreas
0.0069 0.0091
0.014
0.021
Red marrow
0.0050 0.0064
0.0095
0.013
Salivary glands
0.0092 0.011
0.0015
0.0020
Skin
0.0029 0.0037
0.0058
0.0090
Spleen
0.0058 0.0076
0.012
0.017
Testes
0.0037 0.0048
0.0071
0.011
Thymus
0.0040 0.0055
0.0080
0.012
Thyroid
0.0044 0.0064
0.0099
0.019
Uterus
0.0072 0.0093
0.014
0.020
Remaining organs 0.0033 0.0043
0.0064
0.0098
Effective dose
(mSv/MBq)
0.0079 0.010
0.016
0.023

1-year
0.033
0.038
0.036
0.023
0.018
0.26

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
Withdrawals should be performed under aseptic conditions. The vials
must not be opened before disinfecting 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.

0.032
0.066
0.12
0.13

Instructions for Preparation of technetium (99mTc) sestamibi
Preparation of technetium (99mTc) sestamibi from the Technescan MIBI
Kit is to be done according to the following aseptic procedure. The
heating of the preparation can either be done using a water bath or in a
heating block. Both methods are described underneath:

0.099

Method of preparation

0.035
0.11
0.044
0.023
0.017
0.023
0.040
0.035
0.023
0.0029
0.017
0.030
0.020
0.023
0.035
0.035
0.018

Boiling procedure:
1
Waterproof gloves should be worn during the preparation
procedure. Remove the flip-off cap from the Technescan MIBI Kit
vial and swab the top of the vial closure with alcohol to disinfect
the surface.
2
Place the vial in a suitable radiation shield appropriately labelled
with date, time of preparation, volume and activity.
3
With a sterile shielded syringe, aseptically obtain additive-free,
sterile, non-pyrogenic sodium pertechnetate (99mTc) solution max.
11.1 GBq in approximately 1 to 3 ml. Not more than 3 ml sodium
pertechnetate (99mTc) solution will be used for the maximum
activity of 11.1 GBq.
4
Aseptically add the sodium pertechnetate (99mTc) solution to the
vial in the lead shield. Without withdrawing the needle, remove an
equal volume of headspace to maintain atmospheric pressure
within the vial.
5
Shake vigorously, about 5 to 10 quick upward-downward motions.
6
Remove the vial from the lead shield and place upright in an
appropriately shielded and contained boiling water bath, such that
the vial is suspended above the bottom of the bath, and boil for
10 minutes. The bath must be shielded. Timing for the 10 minutes
commences as soon as the water begins to boil again.
Note: The vial must remain upright during the boiling step. Use a
water bath where the stopper will be above the level of the water.
7
Remove the shielded vial from the water bath and allow cooling
for fifteen minutes.
8
Inspect visually for the absence of particulate matter and
discoloration prior to administration.
9
If needed, a dilution with 0.9 % saline solution is possible.
10 Aseptically withdraw material using a sterile shielded syringe. Use
within ten (10) hours of preparation.
11 Radiochemical purity should be checked prior to patient
administration according to the Radio TLC Method as detailed
below.

0.045

The effective dose has been calculated according to a voiding frequency
of 3.5 hours in adults.
Cardiac imaging
The effective dose resulting from the administration of a maximal
recommended activity of 2,000 MBq of technetium (99mTc) sestamibi for
an adult weighing 70 kg is about 16.4 mSv if implementing the one-day
protocol with administration of 500 MBq at rest and 1,500 MBq at
exercise.
For this administered activity of 2,000 MBq the typical radiation dose to
the target organ heart is 14 mGy and the typical radiation doses to the
critical organs gall bladder, kidneys and upper large intestine are
69, 57 and 46.5 mGy, respectively.
The effective dose resulting from the administration of a maximal
recommended activity of 1,800 MBq (900 MBq at rest and 900 MBq at
exercise) of technetium (99mTc) sestamibi for a two-day protocol for an
adult weighing 70 kg is about 15.2 mSv.
For this administered activity of 1,800 MBq the typical radiation dose to
the target organ heart is 12.2 mGy and the typical radiation doses to the
critical organs gall bladder, kidneys and upper large intestine are
64.8, 55.8 and 44.1 mGy, respectively.
Scintimammography
The effective dose resulting from the administration of a maximal
recommended activity of 1,000 MBq of technetium (99mTc) sestamibi for
an adult weighing 70 kg is about 9 mSv.
For an administered activity of 1,000 MBq the typical radiation dose to
the target organ breast is 3.8 mGy and the typical radiation doses to the
critical organs gall bladder, kidneys and upper large intestine are
39, 36 and 27 mGy, respectively.
Parathyroid imaging
The effective dose resulting from the administration of a maximal
recommended activity of 700 MBq of technetium (99mTc) sestamibi for an
adult weighing 70 kg is about 6.3 mSv.
For an administered activity of 700 MBq the typical radiation dose to the
target organ thyroid is 3.7 mGy and the typical radiation doses to the
critical organs gall bladder, kidneys and upper large intestine are
27.3, 25.2 and 18.9 mGy, respectively.

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 5 of 6

12.

DRN 4376

Technescan Sestamibi United Kingdom

Heating block procedure:
1
Waterproof gloves should be worn during the preparation
procedure. Remove the flip-off cap from the Technescan MIBI Kit
vial and swab the top of the vial closure with alcohol to disinfect
the surface.
2
Place the vial in a suitable radiation shield appropriately labelled
with date, time of preparation, volume and activity.
3
With a sterile shielded syringe, aseptically obtain additive-free,
sterile, non-pyrogenic sodium pertechnetate (99mTc) solution max.
11.1 GBq in approximately 3 ml. Not more than 3 ml sodium
pertechnetate (99mTc) solution will be used for the maximum
activity of 11.1 GBq.
4
Aseptically add the sodium pertechnetate (99mTc) solution to the
vial in the lead shield. Without withdrawing the needle, remove
an equal volume of headspace to maintain atmospheric pressure
within the vial.
5
Shake vigorously, about 5 to 10 quick upward-downward motions.
6
Place the vial into the heating block previously heated to 120°C,
and incubate for 10 minutes. The heating block should be
adapted to the size of the vial in order to ensure a correct transfer
of heat from the heating device to the content of the vial.
7
Remove the vial for the heating block and allow cooling to room
temperature.
8
Inspect visually for the absence of particulate matter and
discoloration prior to administration.
9
If needed, a dilution with 0.9 % saline solution is possible.
10 Aseptically withdraw material using a sterile shielded syringe. Use
within ten (10) hours of preparation.
11 Radiochemical purity should be checked prior to patient
administration according to the Radio TLC Method as detailed
below.
Note: the potential for cracking and significant contamination
exists whenever vials containing radioactive material are heated.

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 6 of 6

Quality control
Radio-TLC Method for the Quantification of Technetium (99mTc)
Sestamibi
1.
Materials
1.1 Baker-Flex-Aluminium Oxide plate, # 1 B-F, pre-cut to
2.5 cm x 7.5 cm.
1.2 Ethanol, > 95%.
1.3 Capintec, or equivalent instrument for measuring
radioactivity in the 0.7 - 11.1GBq range.
1.4 1 ml syringe with a 22-26 gauge needle.
1.5 Small developing tank with cover, (100 ml beaker covered
with Parafilm is sufficient).
2.

Procedure
2.1 Pour enough ethanol into the developing tank (beaker) to
have a depth of 3-4 mm of solvent. Cover the tank (beaker)
with Parafilm® and allow it to equilibrate for approximately
10 minutes.
2.2 Apply 1 drop of ethanol, using a 1 ml syringe with a
22-26 gauge needle on to the Aluminium Oxide TLC plate,
1.5 cm from the bottom. Do not allow the spot to dry.
2.3 Apply 1 drop of the kit solution on top of the ethanol spot.
Dry the spot. Do not heat!
2.4 Allow the solvent front to travel for a distance of 5.0 cm from
the spot.
2.5 Cut the strip at 4.0 cm from the bottom, and measure each
piece in your dose calibrator.
2.6 Calculate the % Radiochemical purity as :
% (99mTc) Sestamibi = (Activity top portion)/(Activity both
pieces) x 100.
2.7 % (99mTc) Sestamibi should be ≥ 94%; otherwise the
preparation should be discarded.
Note: Do not use material if the radiochemical purity is less than
94%.

DRN 4376

Technescan Sestamibi United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Technescan MIBI 1 mg, kit for radiopharmaceutical preparation
[Tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)copper(I)] tetrafluoroborate
Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your nuclear medicine doctor who
will supervise the procedure.
If you get any side effects, talk to your nuclear medicine doctor. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Technescan MIBI is and what it is used for
2.
What you need to know before Technescan MIBI is used
3.
How Technescan MIBI is used
4.
Possible side effects
5.
How Technescan MIBI is stored
6.
Contents of the pack and other information
1.
WHAT TECHNESCAN MIBI IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use only.
Technescan MIBI contains a substance called [tetrakis(1-isocyanide-2methoxy-2-methylpropy)copper(I)] tetrafluoroborate which is used to study the
heart function and blood flow (myocardial perfusion) by making an image of
the heart (scintigraphy), for example in the detection of heart attacks
(myocardial infarctions) or when a disease causes reduced blood supply to (a
part of) the heart muscle (ischaemia). Technescan MIBI is also used in the
diagnosis of breast abnormalities in addition to other diagnostic methods when
the results are unclear. Technescan MIBI can also be used to find the position
of overactive parathyroid glands (glands that secrete the hormone that controls
blood calcium levels).
After Technescan MIBI is injected, it temporarily collects in certain parts of the
body. This radiopharmaceutical substance contains a small amount of
radioactivity, which can be detected from outside of the body by using special
cameras. Your nuclear medicine doctor will then take an image (scintigraphy)
of the concerned organ which can give your doctor valuable information about
the structure and the function of this organ or the location of e.g., a tumour.
The use of Technescan MIBI does involve exposure to small amounts of
radioactivity. Your doctor and the nuclear medicine doctor have considered
that the clinical benefit that you will obtain from the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
2.

WHAT YOU NEED TO KNOW BEFORE TECHNESCAN MIBI IS USED

Technescan MIBI must not be used
if you are allergic to tetrakis (1 isocyanide-2-methoxy-2-methylpropyl-)
copper(I)] tetrafluoroborate or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Take special care with Technescan MIBI
if you are pregnant or believe you may be pregnant,
if you are breastfeeding,
if you have a kidney or liver disease.
You should inform your nuclear medicine doctor in case those apply to you.
Your nuclear medicine doctor will inform you if you need to take any special
precautions after using this medicine. Talk to your nuclear medicine doctor if
you have any questions.
Before administration of Technescan MIBI you should
be fasting for at least 4 hours if the product is going to be used to
perform images of your heart,
drink plenty of water before the start of the examination in order to
urinate as often as possible during the first hours after the study.
04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 1 of 2

Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Technescan MIBI
A number of medicines, foods and beverages can adversely affect the
outcome of the planned investigation. It is therefore recommended to discuss
with the referring physician, which intake should be discontinued before the
investigation and when the medicines should be taken again. Tell also your
nuclear medicine doctor if you are taking, have recently taken or might take
any other medicines, since they may interfere with the interpretation of the
images.
Especially tell your nuclear medicine doctor if you are taking medicines which
affect heart function and/or blood flow.
Please ask your nuclear medicine doctor before taking any medicines.
Pregnancy and breastfeeding
You must inform the nuclear medicine doctor before the administration of
Technescan MIBI if there is a possibility you might be pregnant, if you have
missed your period or if you are breastfeeding. When in doubt, it is important
to consult your nuclear medicine doctor who will supervise the procedure.
If you are pregnant,
your nuclear medicine doctor will only administer this medicine during
pregnancy if a benefit is expected which would outweigh the risks.
If you are breastfeeding,
please tell your nuclear medicine doctor, as he/she may advise you to stop
doing so until the radioactivity has left your body. This takes about 24 hours.
The expressed milk should be discarded. Please ask your nuclear medicine
doctor when you can resume breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your nuclear medicine doctor for advice before
taking this medicine.
Driving and using machines
It is considered unlikely that Technescan MIBI will affect your ability to drive or
to use machines.
Technescan MIBI contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e.
essentially ‘sodium- free’.
3.
HOW TECHNESCAN MIBI IS USED
There are strict laws on the use, handling and disposal of radiopharmaceutical
products. Technescan MIBI will only be used in special controlled areas. This
product will only be handled and given to you by people who are trained and
qualified to use it safely. These persons will take special care for the safe use
of this product and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the
quantity of Technescan MIBI to be used in your case. It will be the smallest
quantity necessary to get the desired information.
The quantity usually recommended to be administered for an adult ranges
depending on the test to be performed, and ranges between
200 and 2000 MBq (Megabecquerel, the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to
the child’s weight.
Administration of Technescan MIBI and conduct of the procedure
Technescan MIBI is administered in a vein of the arm or the foot (intravenous
administration). One to two injections is sufficient to conduct the test that your
doctor needs.
After injection, you will be offered a drink and asked to urinate immediately
preceding the test.
The nuclear medicine doctor will inform you if you need to take any special
precautions after receiving this medicine. Contact your nuclear medicine
doctor if you have any questions.
The ready-to-use solution will be injected to you in a vein before the
scintigraphy is taken. The scanning may take place within 5 to 10 minutes or
up to 6 hours after injection, depending on the test.

DRN 4376

Technescan Sestamibi United Kingdom

In the case of a heart investigation, two injections may be necessary, one at
rest and one at stress (e.g., during a physical exercise or pharmacological
stress). The two injections will be done at least two hours apart and not more
than 2000 MBq in total (1 day protocol) will be administered. A two day
protocol is feasible, also.
For the scintigraphy of breast abnormalities, an injection of 750 to 1100 MBq is
administered into a vein of your arm opposite to the breast concerned, or into a
vein of your foot.
To find the position of overactive parathyroid glands, the activity administered
is between 185 and 1100 MBq, depending on the methods used.
If the medicine is going to be used to perform images of your heart, then you
will be asked not to eat anything for at least 4 hours before the test. After the
injection, but before the image (scintigraphy) is made, you will be asked to eat
a light fatty meal, if possible, or to drink one or two glasses of milk in order to
decrease the radioactivity in your liver and to improve the image.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the
procedure.
After administration of Technescan MIBI has been performed, you
should:
avoid any close contact with young children and pregnant women for the
24 hours following the injection,
urinate frequently in order to eliminate the product from your body.
The nuclear medicine doctor will inform you if you need to take any special
precautions after receiving this medicine. Contact your nuclear medicine
doctor if you have any questions.
If you have been given more Technescan MIBI than you should
An overdose is almost impossible because you will only receive a dose of
Technescan MIBI precisely controlled by the nuclear medicine doctor
supervising the procedure. However, in the case of an overdose, you will
receive the appropriate treatment. In particular, the nuclear medicine doctor in
charge of the procedure may recommend that you drink abundantly in order to
facilitate the elimination of Technescan MIBI from your body.
Should you have any further questions on the use of this medicine, please ask
the nuclear medicine doctor who supervises the procedure.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Allergic reactions possibly with shortness of breath, extreme tiredness, being
sick (usually within 2 hours after administration), swelling beneath the skin that
can occur in areas such as the face and limbs (angioedema), and obstruct the
airway, or leading to a dangerous decrease of blood pressure (hypotension)
and slow heart beat (bradycardia) have been seen rarely. Doctors are aware of
this possibility and have emergency treatment available for use in such cases.
Local skin reactions have also been seen rarely with itching, hives, rash,
swelling and redness. If you experience any of those, please refer immediately
to your nuclear medicine doctor.
Other possible side effects are listed in the order of their frequency below:
Frequency

Possible side effects

common: may affect up to 1 in 10
people

Metallic or bitter taste, smell
alteration, and dry mouth
immediately after injection.
Headache, chest pain, abnormal
ECG and feeling sick.
abnormal heart rhythm, local
reactions at the injection site,
stomach ache, fever, fainting,
seizures, dizziness, flushing, skin
numbness or tingling, tiredness, joint
pains and stomach upset
(dyspepsia).
Erythema multiforme, a widespread
rash of skin and mucosa.

uncommon: may affect up to 1 in 100
people
rare: may affect up to 1 in 1,000
people

not known: frequency cannot be
estimated from the available data

04376006BYS04b / 07 CON 4376 United Kingdom SPC 19082014 /
07 CON 4376 United Kingdom PIL 19082014

Page 2 of 2

This radiopharmaceutical will deliver low amounts of ionising radiation
associated with the least risk of cancer and hereditary abnormalities.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.
5.
HOW TECHNESCAN MIBI IS STORED
You will not have to store this medicine. This medicine is stored under the
responsibility of the specialist in appropriate premises. Storage of
radiopharmaceuticals will be in accordance with national regulation on
radioactive materials.
The following information is intended for the specialist only.
This medicine must not be used after the expiry date, which is stated on the
label.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Technescan MIBI contains
-

The active substance is [Tetrakis(2-methoxy-2-methylpropyl-1
isocyanide)copper(I)] tetrafluoroborate.
One vial contains 1 mg [Tetrakis(2-methoxy-2-methylpropyl-1
isocyanide)copper(I)] tetrafluoroborate.

The other ingredients are stannous chloride dihydrate, cysteine hydrochloride
monohydrate, sodium citrate, mannitol, hydrochloric acid and sodium
hydroxide.
What Technescan MIBI looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation.
Technescan MIBI consists of white to almost white pellets or powder which
has to be dissolved in a solution and combined with radioactive technetium
before use as an injection. Once the radioactive substance sodium
pertechnetate (99mTc) is added to the vial, technetium (99mTc) sestamibi is
formed. This solution is ready for injection.
Pack size
5 multi-dose vials
Marketing Authorisation Holder and Manufacturer
Mallinckrodt Medical B.V.
Westerduinweg 3
1755 LE PETTEN, The Netherlands
This leaflet was last revised in July 2014.

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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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