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ULTRA-TECHNEKOW FM

Active substance(s): MOLYBDENUM-99 / SODIUM PERTECHNETATE TC 99M

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ultra-TechneKow FM, 2.15-43.00 GBq, radionuclide generator

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium pertechnetate (99mTc) injection is produced by means of a (99Mo/99mTc)
generator. Technetium (99mTc) decays with the emission of gamma radiation with a
mean energy of 140 keV and a half-life of 6.01 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 radionuclide generator containing the parent isotope 99Mo, adsorbed on a
chromatographic column delivers sodium pertechnetate (99mTc) injection in sterile
solution.
The 99Mo on the column is in equilibrium with the formed daughter isotope 99mTc.
The generators are supplied with the following 99Mo activity amounts at activity
reference time which deliver in equilibrium the following technetium (99mTc)
amounts, assuming a 100% theoretical elution yield and 24 hours time from previous
elution and taking into account that branching ratio of 99Mo is about 87%:
99m

Tc activity
(maximum
activity elutable
at ART, 06.00 h
CET)
99
Mo activity (at
ART, 06.00 h
CET)

1.90

3.81

5.71

7.62

9.53

11.43

15.24

19.05

22.86

26.67

30.48 38.10 GB

2.15

4.30

6.45

8.60

10.75

12.90

17.20

21.50

25.80

30.10

34.40 43.00 GB

The technetium (99mTc) amounts available by a single elution depend on the real
yields of the kind of generator used itself declared by manufacturer and approved by
National Competent Authority.
Excipient(s) with known effect
Each mL of sodium pertechnetate (99mTc) solution contains 3.5 mg of sodium.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Radionuclide generator.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This medicinal product is for diagnostic use only.
The eluate from the generator (Sodium Pertechnetate (99mTc) Injection
Ph. Eur.) may be used as a reagent for labelling of various carrier compounds
supplied as kits or administered directly in-vivo.
A When administered intravenously, the sterile sodium pertechnetate (99mTc)
solution is used as a diagnostic aid in the following:


Thyroid scintigraphy: direct imaging and measurement of
thyroid uptake to give information on the size, position,
nodularity and function of the gland in thyroid disease.

• Salivary gland scintigraphy: to assess salivary gland function
and duct patency.
• Location of ectopic gastric mucosa: Meckel's diverticulum.


Cerebral scintigraphy: to identify breaches in the blood-brain
barrier caused by tumour, infarction, haemorrhage and oedema,
when no other methods are available.

B When used in conjunction with pre-treatment with a reducing agent to effect
technetium (99mTc)-labelling of red blood cells:


Cardiac and vascular scintigraphy
- angiocardioscintigraphy for:
* evaluation of ventricular ejection fraction
* evaluation of global and regional cardiac wall motion
* myocardial phase imaging
-



organ perfusion or vascular abnormalities imaging

Diagnosis and localisation of occult gastrointestinal bleeding.

C Following instillation of sterile sodium pertechnetate (99mTc) solution into
the eye:


Lacrimal duct scintigraphy: to assess patency of tear ducts

4.2

Posology and method of administration
Sodium pertechnetate (99mTc) is normally administered intravenously at
activities which vary widely according to the clinical information required and
the equipment employed. Other activities may be justifiable. It should be noted
that in each country physicians should follow the Diagnostic Reference Levels
and the rules set out by local law. Pre-treatment of patients with thyroid
blocking agents or reducing agents may be necessary for certain indications.
Recommended activities are as follows:
Adults and the elderly:
• Thyroid scintigraphy: 18.5-80 MBq
Scintigraphy performed 20 minutes after intravenous injection.


Salivary gland scintigraphy: 40 MBq
Scintigraphy performed immediately after intravenous injection
and at regular intervals up to 15 minutes.



Meckel's diverticulum scintigraphy: 400 MBq
Scintigraphy performed immediately after intravenous injection
and at regular intervals up to 30 minutes.



Brain scintigraphy: 370-800 MBq
Rapid sequential images are taken immediately within the first
minute after intravenous administration; static images 1 to 4 hours
later. Thyroid and choroid plexus should be blocked to avoid nonspecific 99mTc uptake.



Cardiac and vascular scintigraphy: 740-925 MBq
Red cells are labelled in-vivo or in-vitro by pretreating with a
reducing agent. Dynamic images are taken in the first minute after
intravenous administration, followed by regular images over 30
minutes.



Gastrointestinal bleeding: 740-925 MBq
Red cells are labelled in vivo or in vitro by pretreating with a
reducing agent. Dynamic images are taken in the first minute after
intravenous administration, followed by regular images at
appropriate intervals for up to 24 hours.



Lacrimal duct scintigraphy: 2-4 MBq each eye
Drops are instilled into the eye and dynamic images are taken over
2 minutes, followed by static images at appropriate intervals over
20 minutes.

Children:
The activity for administration to children may be calculated from the
recommended range of adult activity and adjusted according to body weight or
surface area. However, the Paediatric Task Group of EANM recommends that

the activity to be administered to a child should be calculated from the body
weight according to the following table:
Fraction of adult dose:
3 kg = 0.1 4 kg = 0.14
kg = 0.27
12 kg = 0.32
kg = 0.44 20 kg = 0.46
22 kg = 0.50
kg = 0.58 30 kg = 0.62
32 kg = 0.65
kg = 0.73 40 kg = 0.76
42 kg = 0.78
kg = 0.85 50 kg = 0.88
52-54 kg = 0.90
66 kg = 0.98

6 kg = 0.19

8 kg = 0.23

10

14 kg = 0.36

16 kg = 0.40

18

24 kg = 0.53

26 kg = 0.56

28

34 kg = 0.68

36 kg = 0.71

38

44 kg = 0.80

46 kg = 0.82

48

56-58 kg = 0.92 60-62 kg = 0.96 6468 kg = 0.99

In very young children (up to 1 year) a minimum dose of 20 MBq (10 MBq in
thyroid scintigraphy) for direct administration or 80 MBq for red blood cell
labelling is necessary in order to obtain images of sufficient quality.

4.3

Contraindications
Hypersensitivity to the active substance or any of the excipients.

4.4

Special warnings and precautions for use
This radiopharmaceutical may be received, used and administered only by
authorized persons. Its receipt, storage, use, transfer and disposal are subject to
the regulations and the appropriate licences of the local competent official
organizations. Radiopharmaceuticals intended for administration to patients
should be prepared by the user in a manner that satisfies both radiological
safety and pharmaceutical quality requirements. Appropriate aseptic
precautions should be taken, that comply with the requirements of Good
Pharmaceutical Manufacturing Practice for pharmaceuticals.
During brain scintigraphy, pertechnetate uptake may occur in the plexus
choroideus which might be misinterpreted as a damage of the blood brain
barrier (false positive). To avoid such false positives and to minimize
irradiation by reduction of pertechnetate accumulation in the thyroid and
salivary glands, potassium perchlorate should be given prior to brain
scintigraphy; (see also section 5.2). Potassium perchlorate blockade of thyroid
and salivary glands should also be performed in lacrimal duct scintigraphy.

4.5

Interaction with other medicinal products and other forms of interaction
Drug interactions have been reported in brain scintigraphy where there can be
increased uptake of (99mTc) pertechnetate in the walls of cerebral ventricles as
a result of methotrexate-induced ventriculitis. In abdominal imaging drugs,
such as atropine, isoprenaline and analgesics, can result in a delay in gastric
emptying and redistribution of (99mTc) pertechnetate.

4.6

Fertility, Pregnancy and lactation
Pregnancy
99m
Tc (as free pertechnetate) has been shown to cross the placental barrier.
When it is necessary to administer radioactive medicinal products to a woman
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 particularly
important that the radiation exposure should be the minimum consistent with
achieving the desired clinical information. Alternative techniques which do
not involve ionising radiation should be considered.
Radionuclide procedures carried out on pregnant women also involve radiation
doses to the foetus. Only imperative investigations should be carried out
during pregnancy, when the likely benefit exceeds the risk incurred by the
mother and the foetus.
Direct administration of 800 MBq sodium pertechnetate (99mTc) to a patient
results in an absorbed dose to the uterus of 6.5 mGy. Following pretreatment
of patients with a blocking agent, administration of 800 MBq sodium
pertechnetate (99mTc) results in an absorbed dose to the uterus of 4.8 mGy.
Administration of 925 MBq 99mTc labelled red blood cells results in an
absorbed dose to the uterus of 3.6 mGy. Doses above 0.5 mGy should be
regarded as a potential risk to the foetus.
Lactation
Before administering a radioactive medicinal product to a woman who is
breast-feeding, consideration should be given as to whether the investigation
could be reasonably delayed until the mother has ceased breast-feeding and as
to whether the most appropriate choice of radiopharmaceutical has been made.
If the administration is considered necessary, breast-feeding should be
interrupted for at least 12 hours and the expressed feeds discarded. Breastfeeding can be restarted when the activity level in the milk will not result in a
radiation dose to the child greater than 1 mSv.

4.7

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

4.8

Undesirable effects
Information on adverse reactions is available from spontaneous reporting. The
reported reaction types are anaphylactoid reactions, vegetative reactions, as
well as different kinds of injection site reactions. 99mTc-perchtechnetate from
the UltraTechnekow FM generator is used for radioactive labeling of a variety
of compounds. These pharmaceuticals generally have a higher potential for
side effects than 99mTc, and therefore the reported side effects are rather
related to the labelled compounds than to 99mTc. The possible types of side
effects following intravenous administration of a 99mTc-labelled
pharmaceutical preparation will be dependent on the specific compound being
used. Such information should be available from the manufacturer of the
pharmaceutical which is to be radiolabelled.
Anaphylactoid reactions:
Anaphylactoid reactions have been reported following intravenous injection of
99m
Tc-perchtechnetate and include various skin or respiratory symptoms like
skin irritations, oedema, or dyspnoea.
Vegetative reactions (nervous system and gastrointestinal disorders):
Single cases of severe vegetative reactions have been reported, however, most
of the reported vegetative effects include gastrointestinal reactions like nausea
or vomiting. Other reports include vasovagal reactions like headache or
dizziness. Vegetative effects are rather considered to be related to the
examinational setting than to technetium (99mTc), especially in anxious
patients.
General disorders and administration site conditions
Other reports describe local injection site reactions. Such reactions are related
to extravasation of the radioactive material during the injection, and the
reported reactions rank from local swelling up to cellulitis. Depending on the
administered radioactivity and the labeled compound, extended extravasation
may necessitate surgical treatment.
The following table subsumes the observed reaction types and symptoms. Due
to the fact that only spontaneous reports could be analysed, no frequency
indications could be provided.
Adverse Reactions sorted by System Organ Class
Immune system disorders

Frequency unknown*: Anaphylactoid reactions (e.g. Dyspnoea, coma, urticaria,
erythema, rash, pruritus, oedema at various location e.g. face oedema)
Nervous system disorders
Frequency unknown*: Vasovagal reactions (e.g. Syncope, tachycardia, bradycardia,
dizziness, headache, vision blurred, flushing)
Gastrointestinal disorders
Frequency unknown*: Vomiting, nausea, diarrhoea
General disorders and administration site conditions
Frequency unknown*: Injection site reactions (e.g. Cellulitis, pain, erythema,
swelling)
* Adverse reactions derived from spontaneous reporting
For each patient, exposure to ionising radiation must be justifiable on the basis
of likely clinical benefit. The activity administered must be such that the
resulting radiation is as low as reasonably achievable bearing in mind the need
to obtain the intended diagnostic or therapeutic result. Exposure to ionising
radiation is linked with cancer induction and a potential for development of
hereditary defects.
For diagnostic nuclear medicine investigations, the current evidence suggests
that these adverse effects will occur with low frequency because of the low
radiation doses incurred. For most diagnostic investigations using a nuclear
medicine procedure, the radiation dose delivered is less than 20 mSv (EDE).
Higher doses may be justified in some clinical circumstances.
This product contains no ingredients that have a recognised action or effect, or
knowledge of which is important for safe and effective use of the product.

4.9

Overdose
In the event of the administration of a radiation overdose with sodium
pertechnetate (99mTc), the absorbed dose should be reduced where possible by
increasing the elimination of the radionuclide from the body. Measures to
reduce possible harmful effects include frequent voiding of urine and
promotion of diuresis and faecal excretion. Very little supportive treatment can
be undertaken in the event of an overdose of 99mTc-labelled red blood cells
since elimination is dependent on the normal haemolytic process.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Various thyroid diagnostic radiopharmaceuticals

ATC code: V09F X01
No pharmacological activity has been observed in the range of doses
administered for diagnostic purposes

5.2

Pharmacokinetic properties
The pertechnetate ion has similar biological distribution to iodide and
perchlorate ions, concentrating temporarily in salivary glands, choroid plexus,
stomach (gastric mucosa) and in the thyroid gland, from which it is released
unchanged. The pertechnetate ion also tends to concentrate in areas with
increased vascularisation or with abnormal vascular permeability, particularly
when pre-treatment with blocking agents inhibits uptake in glandular
structures.99mTc is selectively excluded from the cerebrospinal fluid.
Following intravenous administration, pertechnetate (99mTc) is distributed
throughout the vascular system from which it is cleared by three main
mechanisms:
• Rapid removal, depending on the diffusion equilibrium with interstitial
fluid
• Intermediate rate of removal, depending on the concentration of the
pertechnetate in glandular tissues, mainly thyroid, salivary and gastric
fundus glands which have an ionic pump mechanism
• Slow removal, by glomerular filtration by the kidneys, dependent on
rate of urinary excretion.
Plasma clearance has a half-life of approximately 3 hours. Excretion during
the first 24 hours following administration is mainly urinary (approximately
25%) with faecal excretion occurring over the next 48 hours. Approximately
50% of the administered activity is excreted within the first 50 hours. When
selective uptake of pertechnetate (99mTc) in glandular structures is inhibited by
the preadministration of blocking agents, excretion follows the same pathways
but there is a higher rate of renal clearance. When pertechnetate (99mTc) is
administered in association with pre-treatment with reducing agents such as
stannous/medronate which cause a "stannous loading" of red blood cells, up to
approximately 95% of the administered activity is taken up by the red blood
cells where it becomes bound within the cells. Any unbound pertechnetate
(99mTc) is cleared by the kidneys; radioactivity in the plasma normally
constitutes less than 5% of the intravascular activity. The fate of the
technetium-99m follows that of the labelled erythrocytes themselves and the
activity is cleared very slowly. A small level of elution of activity from the
circulating red cells is thought to occur.

5.3

Preclinical safety data
There is no information on acute, subacute and chronic toxicity from single or
repeated dose administration. The quantity of sodium pertechnetate (99mTc)

administered during clinical diagnostic procedures is very small and apart
from allergic reactions, no other adverse reactions have been reported.
Reproductive Toxicity: Placental transfer of 99mTc from intravenously
administered sodium pertechnetate (99mTc) has been studied in mice. The
pregnant uterus was found to contain as much as 60% of the injected 99mTc
when administered without perchlorate pre-administration. Studies performed
on pregnant mice during gestation, gestation and lactation, and lactation alone
showed changes in progeny which included weight reduction, hairlessness and
sterility.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
• Sodium chloride
• Water for injections

6.2

Incompatibilities
To date no incompatibilities are known.

6.3

Shelf life

Generator: 21 days from the start of manufacturing and 9 days after activity reference
time (ART).
The calibration date and the expiry date are stated on the label.
Sodium pertechnetate (99mTc) Eluate: after elution, use within 8 hours. This medicinal
product does not require any special storage conditions.
Technevials for elution vials (Techne vials): 36 months
Eluent vial: 36 months
6.4

Special precautions for storage

Generator: do not store above 25 °C.
Eluate: for storage conditions after elution of the medicinal product, see section 6.3.
Generators must be kept in an Ultra-TechneKow Safe (with sufficient lead protection)
or behind an adequate laboratory shield. Storage of radiopharmaceuticals should be in
accordance with national regulations for radioactive materials.

6.5

Nature and contents of container
Generator
The generator consists of a cartridge containing an aluminiumoxide column
charged with 99Mo and locked between two filters. One side of the cartridge is
connected to the shielded, sterile supply needle in the eluent holder. The other
side is connected to the similarly shielded, sterile outlet needle in the elution
station. A second sterile needle in the eluent holder serves to eliminate the
underpressure in the eluent vial under sterile conditions. The generator column
is shielded by sufficient lead, depending on the 99Mo activity. The shielded
generator with the built-in station and the eluent holder are packed in an
hermetically sealed tin, which is also the package. Elution occurs by placing
the eluent vial on the needles in the eluent holder, followed by complete or
partial filling of evacuated vials.
Accessories
The first time an Ultra-Technekow FM is supplied, it comes with:
· 1 TechneVial shield or UltraVial Shield
· 1 Sterile vial shielding, unless supplied with the Ultra-Technekow
Safe.
Each Ultra-Technekow FM is supplied with:
· 7 TechneVials, sterile, evacuated vials of 5, 11 or 25 ml
· 1 Sterile vial is provided with the elution set.
· 1 Eluent vial, 100 ml of sterile, physiological salt solution
· 7 Disinfection swabs
· 7 Labels with the radioactivity symbol.

6.6

Special precautions for disposal
Radiopharmaceutical agents should be used only by qualified personnel with
the appropriate government authorizations for the use and manipulations of
radionuclides. This radiopharmaceutical may be received, used and
administered only by authorised personnel in designated clinical settings. Its
receipt, storage, use, transfer and disposal are subject to the regulations and/or
appropriate licences of local competent official organisations.
Radiopharmaceuticals should be prepared by the user in a manner which
satisfies both radiation safety and pharmaceutical quality requirements.
Appropriate aseptic precautions should be taken complying with the
requirements of Good Pharmaceutical Manufacturing Practice for
radiopharmaceuticals.
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Mallinckrodt Medical B.V.
Westerduinweg 3
1755 LE Petten
Netherlands

8

MARKETING AUTHORISATION NUMBER(S)
PL 12288/0017

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/06/1996
21/03/2001

10

DATE OF REVISION OF THE TEXT
06/04/2017

11

DOSIMETRY (IF APPLICABLE)
According to ICRP 53, the radiation doses absorbed by a patient following
direct administration of sodium pertechnetate (99mTc) are as follows:
(I) Without pre-treatment with blocking agent:
Absorbed dose per unit activity administered (mGy/MBq)
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
Gl tract
Stomach wall
Small intestine
ULI wall
LLI wall
Kidneys
Liver

Adult
3.6E-03
1.9E-02
3.9E-03
2.3E-03

15 Year
4.7E-03
2.3E-02
4.7E-03
2.3E-03

10 Year
7.1E-03
3.4E-02
6.9E-03
3.5E-03

5 Year
1.1E-02
5.1E-02
1.0E-02
5.7E-03

1 Year
1.9E-02
9.1E-02
1.9E-02
1.1E-02

2.9E-02
1.8E-02
6.2E-02
2.2E-02
5.0E-03
3.9E-03

3.6E-02
2.2E-02
7.7E-02
2.8E-02
6.0E-03
4.8E-03

5.0E-02
3.4E-02
1.3E-01
4.6E-02
8.7E-03
8.0E-03

8.1E-02
5.2E-02
2.1E-01
7.4E-02
1.3E-02
1.3E-02

1.5E-01
9.0E-02
3.9E-01
1.4E-01
2.1E-02
2.2E-02

Lungs
Ovaries
Pancreas
Salivary glands
Red marrow
Spleen
Testes
Thyroid
Uterus
Other tissue
Effective Dose Equivalent
(mSv/MBq)

2.7E-03
1.0E-02
5.9E-03
9.3E-03
6.1E-03
4.4E-03
2.7E-03
2.3E-02
8.1E-03
3.4E-03

3.4E-03
1.3E-02
7.2E-03
1.2E-02
7.1E-03
5.3E-03
3.7E-03
3.7E-02
1.0E-02
4.0E-03

5.1E-03
1.9E-02
1.1E-02
1.7E-02
9.8E-03
7.9E-03
5.9E-03
5.6E-02
1.6E-02
6.0E-03

7.9E-03
2.7E-02
1.6E-02
2.4E-02
1.3E-02
1.2E-02
9.3E-03
1.2E-01
2.4E-02
9.3E-03

1.4E-02
4.5E-02
2.7E-02
3.9E-02
2.0E-02
2.1E-02
1.7E-02
2.3E-01
4.0E-02
1.7E-02

1.3E-02

1.6E-02

2.5E-02

4.0E-02

7.3E-02

(II) With pre-treatment with blocking agent:
Absorbed dose per unit activity (mGy/MBq) when blocking agents are
given
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
Gl tract
Stomach wall
Small intestine
Ull wall
LLI wall
Kidneys
Liver
Lungs
Ovaries
Pancreas
Red Marrow
Spleen
Testes
Thyroid
Uterus
Other tissue
Effective Dose Equivalent
(mSv/MBq)

Adult
3.3E-03
3.2E-02
3.8E-03
2.5E-03

15 Year
4.1E-03
3.9E-02
4.5E-03
2.5E-03

10 Year
6.3E-03
5.7E-02
6.7E-03
3.6E-03

5 Year
9.5E-03
8.4E-02
1.0E-02
5.7E-03

1 Year
1.7E-02
1.5E-01
1.8E-02
1.1E-02

3.2E-03
4.1E-03
3.8E-03
4.5E-03
4.7E-03
3.1E-03
2.8E-03
4.7E-03
3.5E-03
4.5E-03
3.2E-03
3.2E-03
2.1E-03
6.6E-03
2.9E-03

4.1E-03
4.9E-03
4.9E-03
5.9E-03
5.7E-03
3.8E-03
3.5E-03
6.0E-03
4.4E-03
5.4E-03
3.9E-03
4.4E-03
3.5E-02
7.9E-03
3.5E-03

6.6E-03
7.6E-03
7.1E-03
9.2E-03
8.2E-03
5.9E-03
5.2E-03
8.9E-03
6.7E-03
7.8E-03
5.9E-03
6.8E-03
5.7E-03
1.2E-02
5.3E-03

9.3E-03
1.1E-02
1.1E-02
1.3E-02
1.2E-02
9.0E-03
7.9E-03
1.3E-02
1.0E-02
1.1E-02
9.0E-03
1.1E-02
9.0E-03
1.8E-02
8.2E-03

1.7E-02
2.0E-02
1.9E-02
2.3E-02
2.1E-02
1.6E-02
1.4E-02
2.3E-02
1.8E-02
1.8E-02
1.6E-02
1.9E-02
1.6E-02
3.0E-02
1.5E-02

5.3E-03

6.6E-03

9.8E-02

1.5E-02

2.6E-02

The effective dose equivalent resulting from an administered activity of
800 MBq sodium pertechnetate (99mTc) is 10.4 mSv. Following pretreatment
of patients with a blocking agent, administration of 800 MBq sodium
pertechnetate (99mTc) results in an effective dose equivalent of 4.24 mSv.
(III) The radiation doses absorbed by a patient following intravenous injection
of 99mTc labelled red blood cells are as follows:

Absorbed dose per unit activity administered (mGy/MBq)
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
Gl tract
Stomach wall
Small intest
ULI wall
LLI wall
Heart
Kidneys
Liver
Lungs
Ovaries
Pancreas
Red marrow
Spleen
Testes
Thyroid
Uterus
Other tissue
Effective Dose Equivalent
(mSv/MBq)

Adult
8.7E-03
9.2E-03
9.2E-03
4.3E-03

15 Year
1.1E-02
1.2E-02
1.3E-02
4.5E-03

10 Year
1.7E-02
1.7E-02
2.3E-02
7.2E-03

5 Year
2.7E-02
2.5E-02
3.9E-02
1.1E-02

1 Year
4.9E-02
4.6E-02
7.8E-02
1.9E-02

4.8E-03
4.4E-03
4.3E-03
3.9E-03
2.3E-02
1.0E-02
7.5E-03
1.4E-02
4.2E-03
6.2E-03
7.3E-03
1.5E-02
2.7E-03
4.9E-03
4.7E-03
3.7E-03

6.1E-03
5.3E-03
5.5E-03
5.3E-03
2.8E-02
1.2E-02
8.8E-03
1.8E-02
5.4E-03
7.5E-03
8.8E-03
1.8E-02
3.7E-03
7.1E-03
5.7E-03
4.4E-03

9.5E-03
8.1E-03
7.9E-03
8.0E-03
4.1E-02
1.9E-02
1.4E-02
2.9E-02
7.9E-03
1.1E-02
1.3E-02
2.8E-02
5.4E-03
1.2E-02
8.5E-03
6.4E-03

1.4E-02
1.2E-02
1.3E-02
1.1E-02
6.2E-02
3.0E-02
2.1E-02
4.5E-02
1.2E-02
1.7E-02
2.0E-02
4.4E-02
8.3E-03
1.9E-02
1.3E-02
9.8E-03

2.4E-02
2.2E-02
2.1E-02
2.1E-02
1.1E-01
5.5E-02
3.8E-02
8.5E-02
2.1E-02
2.9E-02
3.5E-02
8.4E-02
1.5E-02
3.5E-02
2.2E-02
1.8E-02

8.5E-03

1.1E-02

1.6E-02

2.5E-02

4.6E-02

The effective dose equivalent resulting from an administration of 925 MBq
99m
Tc-labelled red blood cells is 7.86 mSv.
(IV) The radiation dose absorbed by the lens of the eye following
administration of sodium pertechnetate (99mTc) for lacrimal duct scintigraphy
is estimated to be 0.038 mGy/MBq. This results in an effective dose
equivalent of less than 0.01 mSv for an administered activity of 4 MBq.

12. INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS

Schematic of the Ultra-TechneKow FM:
1 Top cover
2 Elution station
3 Eluent vial chamber
4 Plastic cover for eluent needle
5 Rubber cover for eluate needle
6 Eluate outlet needle
7 Safety valve
8 Valve for partial elution
9 Lever closing ring
10 Air filter for partial elution
11 Inlet needle for sterile air
12 Eluent inlet needle
13 Air filter for eluent bottle
14 Containment
15 Lead shield
16 Support for lead shield
17 Generator column

Instructions for use
The elution must be carried out in an area capable of maintaining the sterility of the
generator.
Preparation
1 Remove the seal, open the lever closing ring and store it together with the top
cover.
2 Put the Ultra-TechneKow FM in the Ultra-TechneKow SAFE or behind any other
suitable laboratory shielding with the elution station facing forward.
NB The needles are sterile beneath their covers and the generator underneath the
top is clean, therefore disinfection with liberal amounts of disinfectants containing
alcohol is undesirable and moreover may influence the pertechnetate (99mTc) yield
unfavourably.
3 Remove the flip-off cover from the capsule of the eluent vial, disinfect the
stopper, remove (and store) the plastic cover of the inlet needle and lower the
eluent vial into its holder.
4 Remove the flip-off cover from the capsule of the sterile vial and put it into the
sterile vial shielding.
5 Remove (and store) the rubber needle protection from the outlet needle and lower
the shielded sterile vial into the elution station.
Elution
1 Remove the flip-off cover from the capsule of the required TechneVial, disinfect
the stopper, let the disinfectant evaporate completely and put the vial into the
UltraVial Shielding. (The TechneVial contains some residual water as a result of
the sterilisation process.)
2 Replace the shielded sterile vial by the UltraVial Shield, ensure the lead glass
window faces front.
3 Elution starts. The process can be interrupted depending on the required elution
volume (Pertechnetate (99mTc) concentration/ml). Elution is always ended by
giving the UltraVial Shield a quarter turn, pushing it down and waiting for a few
seconds (this causes the TechneVial to be filled with sterile air).
4 Replace the TechneVial Shielding by a shielded unused sterile vial.

Never interrupt elution by lifting the TechneVial Shield without the quarter
turn!
Eluates that are not clear or colourless must be rejected.
Disposal of waste and return of the generator
1 Remove and dispose of the used sterile vial and the eluent vial.
2 Replace the original needle cover back on the inlet needles.
3 Elute the remaining millilitres of fluid from the generator (see under elution). The
generator is now dry.
4 Replace the original outlet needle cover on the outlet needle.
5 Close the generator system with its top cover and lever closing ring.
6 Store the generator in a suitable place for decay to a level acceptable for disposal.
NB: In some countries the possibility exists to return expired generators. Consult the
local representative for such a possibility or for details of dismantling.
Elution of the generator must be performed in premises complying with the national
regulations
concerning the safety of use of radioactive products.
The solution eluted is a clear and colourless sodium pertechnetate (99mTc) solution,
with a pH between 4 and 8 and a radiochemical purity equal to or greater than 99%.
When sodium pertechnetate (99mTc) solution is used for kit labelling, please refer to
the package leaflet of the concerned kit.
Quality control
Radioactivity and molybdenum (99Mo) break-through must be checked before
administration.
The test for molybdenum (99Mo) break-through can be performed either according to
Ph. Eur. or to any other validated methods able to determine molybdenum (99Mo)
content below 0.1% of total radioactivity at the date and hour of administration.
The first eluate obtained from this generator can be normally used, unless otherwise
specified. Eluates even eluted later than 24 hours from the last elution can be used for
kit labelling, unless it is excluded by the specifications of the relevant kit SmPC

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Further information

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