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DRYTEC 2.5-100 GBQ RADIONUCLIDE GENERATOR

Active substance(s): SODIUM MOLYBDATE MO 99 / SODIUM PERTECHNETATE TC 99M

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Package leaflet: Information for the user
Drytec 2.5-100 GBq radionuclide generator
(called Drytec in this leaflet)
Sodium [99mTC]pertechnetate
Read all of this leaflet carefully before you are given Drytec
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 Drytec is and what it is used for
2. Before you are given Drytec
3. How Drytec is given
4. Possible side effects
5. How to store Drytec
6. Contents of the pack and other information
1. What Drytec is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Drytec is used to help identify illness.
Drytec is a ‘radionuclide generator’. It is used to make a liquid which
is a ‘radiopharmaceutical medicine’. This liquid is given before a scan
and helps a special camera see inside a part of your body.
• It contains an active ingredient called ‘sodium pertechnetate’.
• Once the liquid is injected it can be seen from outside your body
by a special camera used in the scan.
• The scan can help your nuclear medicine doctor to see how well
certain parts of your body are working such as the thyroid gland,
saliva glands, brain, tear ducts and heart.
• Some other people are given this medicine to see how well fluids,
such as the blood, are circulating within the body.
• It can be used to find bleeding in the gut.
• It can also be used to find a small pouch that some people have in
the wall of their gut (‘Meckel’s diverticulum’).
Your nuclear medicine doctor or nurse will explain which part of your
body will be scanned.
The use of Drytec does involve exposure to radioactivity. Your nuclear
medicine doctor will have considered that the clinical benefit that
you will obtain from the procedure with the radiopharmaceutical
outweighs the risk due to radiation.
2. Before you are given Drytec
You should not be given Drytec if:
- if you are allergic (hypersensitive to Sodium [ 99mTC]pertechnetate
or any of the other ingredients of this medicine (listed in section 6).
Do not have Drytec if the above applies to you. If you are not sure
talk to your nuclear medicine doctor or nurse.
Warnings and precautions
Talk to your nuclear medicine doctor before having Drytec.
Take special care:
- If you are pregnant or believe you may be pregnant
- If you are breast-feeding
- If you are on a low sodium diet.
Before administration of Drytec you should:
- Drink lots of water
- If the scan is being used used to find a small pouch that some
people have in the wall of their gut (‘Meckel’s diverticulum’) you
should keep an empty stomach for around 3-4 hours before
administration
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old
Other medicines and Drytec
Please tell your nuclear medicine doctor if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription. This includes medicines
obtained without a prescription. This includes herbal medicines.
This is because some medicines can affect the way Drytec works.
Before you have Drytec tell your nuclear medicine doctor or nurse if
you are taking any of the types of medicine below. This is because
they may affect the results of your scan.
For a brain scan:
• Methotrexate (used for lots of different illnesses, such as
rheumatoid arthritis and some types of cancers).

Measure bar should be 150mm at 100% scale

For an abdominal scan:
• Atropine (used for heart, muscle or eye problems).
• Isoprenaline (used for heart problems).
• Painkillers.
If you are not sure if any of the above apply to you, talk to your
nuclear medicine doctor or nurse before having Drytec.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your nuclear medicine doctor for
advice before you are given this medicine.
You must inform the nuclear medicine doctor before the
administration of Drytec if there is a possibility you might be
pregnant, if you have missed your period of if you are breast-feeding.
When in doubt, it is important to consult your nuclear medicine
doctor who will supervise the procedure.
If you are pregnant
The nuclear medicine doctor will only administer this product during
pregnancy if a benefit is expected which would outweigh the risks.
Do not breast-feed if you are given Drytec. This is because small
amounts of ‘radioactivity’ may pass into the mother’s milk.
If you are breast-feeding
Your nuclear medicine doctor may wait until you have finished
breastfeeding before giving you Drytec. If it is not possible to wait
your nuclear medicine doctor will ask you to:
• stop breast-feeding, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.
Please ask your nuclear medicine doctor when you can resume
breast-feeding.
Driving and using machines
Ask your nuclear medicine doctor if you can drive or use machines
after you have been given Drytec.
Important information about Drytec
When Drytec is used you are exposed to radioactivity.
• Your nuclear medicine doctor will always consider the possible
risks and benefits before you are given the medicine.
Ask your nuclear medicine doctor if you have any questions.
Drytec contains sodium chloride and water for injections.
3. How Drytec is given
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Drytec 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 Drytec to be used in your case. It will be the smallest
quantity necessary to get the desired information. The quantity to
be administered usually recommended for an adult ranges from 2 to
925 MBq (megabecquerel, the unit to express radioactivity).
• Drytec will always be used in a hospital or clinic.
• You may be asked to take a medicine to stop radioactivity building
up in your thyroid gland.
• They will tell you anything you need to know for its safe use.
Your nuclear medicine doctor will decide the dose that is best for you.
Use in children and adolescents
In children and adolescents, the quantity to be administered will be
adapted to the child’s weight. Children and adolesents may be asked to
take a medicine to stop radioactivity building up in your thyroid gland.
Administration of Drytec and conduct of the procedure
Drytec is administered intravenously.
One injection is suffiecient to conduct the test that your nuclear
medicine doctor needs.
For a scan of the tear ducts you will be given drops into the eye.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual
duration of the procedure.
After administration Drytec, you should:
- try to go to the toilet as often as possible
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 your have any questions.
If you have been given more Drytec than you should
An overdose is unlikely because you will only receive a single dose
of Drytec precisely controlled by the nuclear medicine doctor
supervising the procedure. However, in the case of an overdose, you
will receive the appropiate treatment.

Should you have any further questions on the use of Drytec, please
ask the nuclear medicine doctor who supervises the procedure.
4. Possible side effects
This radiopharmaceutical will deliver low amounts of ionising
radiation associated with the least risk of cancer and hereditary
abnormalities.
Like all medicines, Drytec can cause side effects, although not
everybody gets them. These can include:
• Allergic reaction
• dizziness
• headache
• blurred vision
• feeling sick & vomitting
• diarrhoea
• swelling, pain or redness at the injection site
Allergic reactions
If you have an allergic reaction when you are in hospital or a clinic
having the scan, tell the nuclear medicine doctor or nurse straight
away. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty breathing.
In more serious cases reactions may include:
• a change in your heart rate (fast, slow or irregular)
• coma (unconsciousness).
If any of the side effects above happen after you leave the hospital or
clinic, you should go or be taken straight to the casualty department
of your nearest hospital.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the national reporting system:
United Kingdom:
Via the Yellow card scheme at www.mhra.gov.uk/yellowcard
Ireland:
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 67 64971
Fax: +353 1 67 62517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Drytec
Drytec is kept out of the reach and sight of children.
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.
Keep this medicine out of the sight and reach of children.
The following information is intended for the specialist only.
6. Contents of the pack and other information
What Drytec contains
• The active substance is sodium [ 99mTc]pertechnetate
• The other ingredients are sodium chloride and water for injections.
What Drytec looks like and contents of the pack
Drytec is a radionuclide generator. The internal generator
components are contained within a plastic casing fitted with a
carrying handle.
Marketing Authorisation Holder and Manufacturer
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
This leaflet was last revised in 03/2014
Marketing Authorisations
UK: PL 00221/0106
IE : PA 240/21/1
Drytec is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.

GE Healthcare GE Healthcare
PATIENT INFORMATION

Drytec ™

2.5-100 GBq
radionuclide generator
Sodium [99mTc]
pertechnetate
MCD

9 9 9 9 9 9 9

Measure bar should be 150mm at 100% scale

P/5977/02

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DRYTEC 2.5-100 GBq radionuclide generator
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The mother nuclide is:

Sodium [99Mo]molybdate 2.5-100 GBq/generator

(no carrier added)

at the activity reference date
The daughter nuclide is:
Sodium [99mTc]pertechnetate Variable
The quantity of Sodium Pertechnetate (99mTc) Injection Ph. Eur. that may be eluted from the generator at any one time
is dependent on the quantity of sodium [99Mo]molybdate present, the volume of eluate obtained and the lapsed time
since the previous elution.
Technetium-99m 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 hours to technetium-99 which, in view of its long half-life of
2.13 x 105 years can be regarded as quasi stable.
Excipients with known effect:
Sodium: 3.54 mg/ml. This needs to be taken into consideration for patients on a controlled sodium diet.
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. When administered intravenously, the
sterile sodium [99mTc]pertechnetate solution is indicated in adults and children as a diagnostic aid in the following:(a) 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.
(b) Salivary gland scintigraphy: to assess salivary gland function and duct patency.
(c) Location of ectopic gastric mucosa: Meckel’s diverticulum
(d) Cerebral scintigraphy: to identify breaches in the blood-brain barrier caused by tumour, infarction, haemorrhage
and oedema, when no other methods are available.
When used in conjunction with pre-treatment with a reducing agent to effect technetium-99m-labelling of red blood
cells:
(e) 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
(f) Diagnosis and localisation of occult gastrointestinal bleeding
Following instillation of sterile sodium [99mTc]pertechnetate solution into the eye.
(g) Lacrimal duct scintigraphy: to assess patency of tear ducts
4.2 Posology and method of administration
Posology
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 non-specific technetium-99m 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 pre-treating 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.
Paediatric population
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 European Association Nuclear Medicine 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:
42 kg   = 0.78
22 kg = 0.50
3 kg = 0.1
44 kg   = 0.80
24 kg = 0.53
4 kg = 0.14
46 kg   = 0.82
26 kg = 0.56
6 kg = 0.19
48 kg   = 0.85
28 kg = 0.58
8 kg = 0.23
50 kg   = 0.88
30 kg = 0.62
10 kg = 0.27
52-54 kg = 0.90
32 kg = 0.65
12 kg = 0.32
56-58 kg = 0.92
34 kg = 0.68
14 kg = 0.36
60-62 kg = 0.96
36 kg = 0.71
16 kg = 0.40
64-66 kg = 0.98
38 kg = 0.73
18 kg = 0.44
68 kg   = 0.99
40 kg = 0.76
20 kg = 0.46
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.
The instructions for preparation of radiopharmaceuticals are given in section 12.
Method of administration
Sodium [99mTc]pertechnetate is normally administered intravenously at activities which vary widely according to the
clinical information required and the equipment employed. Pre-treatment of patients with thyroid blocking agents or
reducing agents may be necessary for certain indications.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Information on contraindications when using a kit for radiopharmaceutical preparation should be sought in the pack
insert of the kit for radiopharmaceutical preparation.
4.4 Special warnings and precautions for use
Potential for Hypersensitivity or anaphylactic reactions
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, 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 result.
Renal impairment, hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure
is possible.
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).
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. Thyroid blocking is of special importance when performing cerebral scintigraphy
in the paediatric population.
Patient preparation
Premedication of patients with thyroid-blocking medicinal products may be necessary for certain indications.
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.
Before the application of Sodium [99mTc]pertechnetate-solution for scintigraphy of Meckel’s diverticulum the patient
should keep an empty stomach for 3 to 4 hours to reduce intestinal peristalsis.
In thyroid gland scintigraphy, salivary gland scintigraphy or location of ectopic gastric mucosa concomitant application
of Sodium perchlorate is associated with reduced uptake of radioactivity in glandular tissue.

Measure bar should be 150mm at 100% scale

In cerebral scintigraphy there is also an uptake of Sodium Pertechnetate (99mTc) in the plexus choroideus that may
be misinterpreted as misfunction of the blood-brain barrier (false-positive finding). To reduce the likelihood of
misinterpretation and to reduce radiation exposure pre-treatment with Perchlorate is recommended as Perchlorate
reduces uptake of Sodium Pertechnetate (99mTc) to the plexus choroideus.
In Shuntscintigraphy blocking of the thyroid gland to reduce radiation exposure is also necessary as with shunts with
normal passability complete activity reaches the peritoneal cavity where it is absorbed and systemically distributed.
After in vivo labelling of erythrocytes using stannous ions for reduction Sodium Pertechnetate (99mTc) is primarily built
into erythrocytes, therefore Meckel scintigraphy should be performed before or some days after in vivo labelling of
erythrocytes.
Specific warnings
This medicinal product contains 0.15 mmol/ml (3.54 mg/ml) sodium. To be taken into consideration by patients on a
controlled sodium diet
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.
Thyroid hormones, iodine, iodide, perchlorate, thiocyanate, aluminium containing antacids, sulfonamides and products
containing stannous (II) ions may to increased concentrations of Sodium Pertechnetate (99mTc) in the vascular space,
in the case of stannous (II) ions and sulfonamides the concentration of Sodium Pertechnetate (99mTc) in red blood cells
may be increased, and there may be decreased accumulation in plasma and cerebral lesions. Such medicines should be
discontinued several days before the procedure.
Iodine containing radiologic contrast media and perchlorate may decrease uptake of 99mTc-Pertechnetate to digestive
mucous. Barium sulphate absorbs most of gamma radiation of the tracer. Scintigraphy of Meckel’s diverticulum should
therefore be performed at the earliest 2-3 days after application of these substances. Laxatives may increase transport
of 99mTc-Pertechnetate from the stomach and the intestine and should not be taken before performing scintigraphy
of Meckel’s diverticulum.
The possible types of interactions following intravenous administration of a 99mTclabelled pharmaceutical preparation
will be dependent on the specific compound being used. Such information can be found in the SmPC of the kit used for
radiopharmaceutical preparation.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
Where 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.
Pregnancy
Technetium-99m (as free pertechnetate) has been shown to cross the placental barrier. 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 [99mTc]pertechnetate to a patient results in an absorbed dose to the uterus of 6.5 mGy. Following
pre-treatment of patients with a blocking agent, administration of 800 MBq sodium [99mTc]pertechnetate results in an
absorbed dose to the uterus of 5.3 mGy. Administration of 925 MBq technetium-99m labelled red blood cells results in
an absorbed dose to the uterus of 4.3 mGy. Doses above 0.5 mGy should be regarded as a potential risk to the foetus.
Breast-feeding
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 12 hours and the expressed feeds discarded. Breast feeding can be restarted
when the activity level in the milk will not result in a radiation dose to the child greater than 1mSv.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Summary of the safety profile:
Information on adverse reactions is available from spontaneous reporting. The reported reaction types are
hypersensitivity or anaphylactoid reactions, unspecific systemic reactions, as well as injection site reactions.
Sodium pertechnetate (99mTc) from the Drytec radionuclide generator is used for radioactive labelling of a variety
of compounds. These medicinal products generally have a higher potential for adverse reactions than 99mTc, and
therefore the reported adverse reactions are rather related to the labelled compounds than to 99mTc.
Possible side-effects following the intravenous administration of 99mTc-labelled pharmaceuticals prepared by
radiolabelling with Sodium (99mTc) Pertechnetate Solution will be dependent on the specific pharmaceutical being used.
Such information can be found in the SmPC of the kit used for radiopharmaceutical preparation.
Tabulated list of adverse reactions
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 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, and swelling)
* Adverse reactions derived from spontaneous reporting
Unspecific systemic reactions and gastrointestinal disorders are rather considered to be related to the examinational
setting than to technetium (99mTc), especially in anxious patients.
Injection site reactions are related to extravasation of the radioactive material during the injection and may range from
local swelling up to cellulitis.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
As the effective dose is 10.4 mSv when the maximal recommended activity of 800 MBq is administered these adverse
reactions are expected to occur with a low probability.
For most diagnostic investigations using a nuclear medicine procedure, the effective dose is less than 20 mSv. Higher
doses may be justified in some clinical circumstances.
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
United Kingdom:
Yellow card scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
In the event of the administration of a radiation overdose with sodium [99mTc]pertechnetate, 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 technetium-99m labelled red blood
cells since elimination is dependent on the normal haemolytic process.
The uptake in the thyroid, salivary glands and the gastric mucosa can be significantly reduced when sodium perchlorate
is given immediately after an accidentally high dose of sodium pertechnetate (99mTc) was administered.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, technetium-99m pertechnetate, ATC code: V09FX01
Pharmacodynamic effects
No pharmacological activity has been observed in the range of doses administered for diagnostic purposes.
5.2 Pharmacokinetic properties
Distruibution
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.
Technetium-99m is selectively excluded from the cerebrospinal fluid.
Elimination
Following intravenous administration, [99mTc]pertechnetate 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 [99mTc]pertechnetate in glandular structures is inhibited by the pre-administration of blocking
agents, excretion follows the same pathways but there is a higher rate of renal clearance.
When [99mTc]pertechnetate 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 [99mTc]pertechnetate
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
(a) There is no information on acute, subacute and chronic toxicity from single or repeated dose administration.
The quantity of sodium [99mTc]pertechnetate administered during clinical diagnostic procedures is very small and
apart from allergic reactions, no other adverse reactions have been reported.
(b) Reproductive Toxicity
Placental transfer of technetium-99m from intravenously administered sodium [99mTc]pertechnetate solution has
been studied in mice. The pregnant uterus was found to contain as much as 60% of the injected technetium-99m
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
The technetium-99m is generated from sodium [99Mo]molybdate adsorbed onto an alumina column.
The generator column is eluted with sodium chloride solution to produce the eluate, Sodium Pertechnetate (99mTc)
Injection, which contains the following excipients:
Sodium chloride
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
The expiry date for the generator is 24 days from the date of manufacture. The reference and expiry dates are stated on
the generator label.
The generator eluate, Sodium Pertechnetate (99mTc) Injection, should be used within 8 hours of elution.
The shelf-life for the sodium chloride eluent is 3 years.
6.4 Special precautions for storage
Store the generator and the eluate, Sodium Pertechnetate (99mTc) Injection, below 25ºC. Do not freeze.
Store the sodium chloride eluent below 25ºC. Do not freeze.
Storage should be in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
The Drytec generator comprises a neutral borosilicate glass column containing alumina on which is adsorbed sodium
[99Mo]molybdate. The column is sealed with a natural rubber closure and a pure gum closure and aluminium overseals.
An air-vented inlet spike is connected by silicone tubing to the top of the column. A stainless steel outlet needle is
connected to a sterilising filter, which is connected by silicone tubing to the bottom of the column. Three variants of the
generator are supplied which differ in the design of the column geometry and shielding materials. The type of generator
is indicated by the generator weight which is given on the generator label. The column is surrounded by lead (11 kg and
15 kg generator) or depleted uranium and tungsten shielding (17 kg generator). The internal generator components are
contained within a robust plastic casing fitted with a carrying handle.
To elute the generator a vial of sodium chloride solution is placed onto the inlet spike. The sodium chloride eluent is
contained in a Type I glass vial sealed with a bromobutyl rubber stopper and a plastic flip-top protected aluminium
overseal. The eluent vials are packed in cartons. A range of different volumes of sodium chloride eluent can be supplied
with the generator. Collection of the eluate, Sodium Pertechnetate (99mTc) Injection, is achieved by placing a sterile
evacuated elution vial comprising a clear glass vial sealed with a rubber closure and metal overseal onto the elution port.
Elution kits and accessories
6.5.1 Elution kit provided with the generator
The following items are provided with the generator:
• saline eluent vials each containing 0.9% sodium chloride solution.
• evacuated vials for collection of the generator eluate
• sterile inlet spike protectors - to maintain sterility of the generator system if the saline vial is removed between
elutions
• sterile closed cell foam collection needle protectors - to maintain sterility of the generator system between elutions
• spare sterile needles - to enable the user to replace the collection needle
• spare bactericidal sanitising swabs - to sanitise saline vial and collection vial closures prior to carrying out elutions
• vial labels - to record the activity, volume and time of elution
• technical leaflet
• leaflet relating to the handling, use, storage and disposal of radiopharmaceuticals
• information pack relating to the return of generators to GE Healthcare Limited.
6.5.2 Accessories available
Saline eluent vials
The saline eluent is available in a range of different volumes to allow the generator eluate to be collected at varying
radioactive concentrations.
Packs of vials containing 0.9% sodium chloride solution. Vials are packed in cartons.
Evacuated collection vials
Vials are packed in cartons.
6.6 Special precautions for disposal and other handling
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 licenses 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.
For instructions on elution of the medicinal product before administration, see section 12.
If at any time in the preparation of this product the integrity of this generator 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 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.
After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any
unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in
accordance with the conditions specified by the local competent authority. Contaminated material must be disposed
of as radioactive waste via an authorised route.
7. MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
UK: PL 00221/0106
Cyprus: S00418
Estonia: 474205
Finland: 11213
Latvia: 01-0399
Greece: 2582201
Hungary: OGYI-T-9098/01-04
Romania: 3416/2003/01

Ireland: PA 240/21/1
Russia: FS#2005/446
Norway: MTNr 8323
Mexico: 1447R97
Sweden: 80028
Singapore: SIN12480P
Belarus: 1078/97/98/02/03/06
Malyasia: MAL19910244X

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
UK
Ireland

Date of first authorisation
16 February 2000
23 August 1999

10. DATE OF REVISION OF THE TEXT
05/2014

Date of last renewal
31 July 2005
19 November 2004

11. DOSIMETRY
The tables below show the dosimetry as calculated according to the publication 80 of the ICRP (International Commission
on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon Press 1998).
(i) Without pre-treatment with blocking agent
Organ
Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 Year
10 Year
5 Year
1 Year
Adrenals
3.7E-03
4.7E-03
7.2E-03
1.1E-02
1.9E-02
Bladder
1.8E-02
2.3E-02
3.0E-02
3.3E-02
6.0E-02
Bone surfaces
5.4E-03
6.6E-03
9.7E-03
1.4E-02
2.6E-02
Brain
2.0E-03
2.5E-03
4.1E-03
6.6E-03
1.2E-02
Breast
1.8E-03
2.3E-03
3.4E-03
5.6E-03
1.1E-02
Gall Bladder
7.4E-03
9.9E-03
1.6E-02
2.3E-02
3.5E-02
GI tract
Stomach
2.6E-02
3.4E-02
4.8E-02
7.8E-02
1.6E-01
SI
1.6E-02
2.0E-02
3.1E-02
4.7E-02
8.2E-02
Colon
4.2E-02
5.4E-02
8.8E-02
1.4E-01
2.7E-01
(ULI
5.7E-02
7.3E-02
1.2E-01
2.0E-01
3.8E-01)
(LLI
2.1E-02
2.8E-02
4.5E-02
7.2E-02
1.3E-01)
Heart
Kidneys
Liver
Lungs
Muscles

3.1E-03
5.0E-03
3.8E-03
2.6E-03
3.2E-03

4.0E-03
6.0E-03
4.8E-03
3.4E-03
4.0E-03

6.1E-03
8.7E-03
8.1E-03
5.1E-03
6.0E-03

9.2E-03
1.3E-02
1.3E-02
7.9E-03
9.0E-03

1.7E-02
2.1E-02
2.2E-02
1.4E-02
1.6E-02

Oesophagus
Ovaries
Pancreas
Red Marrow
Salivary glands
Skin

2.4E-03
1.0E-02
5.6E-03
3.6E-03
9.3E-03
1.8E-03

3.2E-03
1.3E-02
7.3E-03
4.5E-03
1.2E-02
2.2E-03

4.7E-03
1.8E-02
1.1E-02
6.6E-03
1.7E-02
3.5E-03

7.5E-03
2.6E-02
1.6E-02
9.0E-03
2.4E-02
5.6E-03

1.4E-02
4.5E-02
2.7E-02
1.5E-02
3.9E-02
1.0E-02

Spleen
Testes
Thymus
Thyroid
Uterus

4.3E-03
2.8E-03
2.4E-03
2.2E-02
8.1E-03

5.4E-03
3.7E-03
3.2E-03
3.6E-02
1.0E-02

8.1E-03
5.8E-03
4.7E-03
5.5E-02
1.5E-02

1.2E-02
8.7E-03
7.5E-03
1.2E-01
2.2E-02

2.1E-02
1.6E-02
1.4E-02
2.2E-01
3.7E-02

Remaining organs
Effective Dose (mSv/MBq)

3.5E-03
1.3E-02

4.3E-03
1.7E-02

6.4E-03
2.6E-02

9.6E-03
4.2E-02

1.7E-02
7.9E-02

(ii) With pre-treatment with blocking agent
Organ
Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI tract
Stomach
SI
Colon
(ULI
(LLI

Absorbed dose per unit activity (mGy/MBq) when blocking agents are given
Adult
15 Year
10 Year
5 Year
1 Year
2.9E-03
3.7E-03
5.6E-03
8.6E-03
1.6E-02
3.0E-02
3.8E-02
4.8E-02
5.0E-02
9.1E-02
4.4E-03
5.4E-03
8.1E-03
1.2E-02
2.2E-02
2.0E-03
2.6E-03
4.2E-03
7.1E-03
1.2E-02
1.7E-03
2.2E-03
3.2E-03
5.2E-03
1.0E-02
3.0E-03
4.2E-03
7.0E-03
1.0E-02
1.3E-02
2.7E-03
3.5E-03
3.6E-03
3.2E-03
4.2E-03

3.6E-03
4.4E-03
4.8E-03
4.3E-03
5.4E-03

5.9E-03
6.7E-03
7.1E-03
6.4E-03
8.1E-03

8.6E-03
1.0E-02
1.0E-02
1.0E-02
1.1E-02

1.5E-02
1.8E-02
1.8E-02
1.7E-02)
1.9E-02)

Heart
Kidneys
Liver
Lungs
Muscles

2.7E-03
4.4E-03
2.6E-03
2.3E-03
2.5E-03

3.4E-03
5.4E-03
3.4E-03
3.1E-03
3.1E-03

5.2E-03
7.7E-03
5.3E-03
4.6E-03
4.7E-03

8.1E-03
1.1E-02
8.2E-03
7.4E-03
7.2E-03

1.4E-02
1.9E-02
1.5E-02
1.3E-02
1.3E-02

Oesophagus
Ovaries
Pancreas
Red Marrow
Skin

2.4E-03
4.3E-03
3.0E-03
2.5E-03
1.6E-03

3.1E-03
5.4E-03
3.9E-03
3.2E-03
2.0E-03

4.6E-03
7.8E-03
5.9E-03
4.9E-03
3.2E-03

7.5E-03
1.1E-02
9.3E-03
7.2E-03
5.2E-03

1.4E-02
1.9E-02
1.6E-02
1.3E-02
9.7E-03

Spleen
Testes
Thymus
Thyroid
Uterus

2.6E-03
3.0E-03
2.4E-03
2.4E-03
6.0E-03

3.4E-03
4.0E-03
3.1E-03
3.1E-03
7.3E-03

5.4E-03
6.0E-03
4.6E-03
5.0E-03
1.1E-02

8.3E-03
8.7E-03
7.5E-03
8.4E-03
1.4E-02

1.5E-02
1.6E-02
1.4E-02
1.5E-02
2.3E-02

Remaining organs
Effective Dose (mSv/MBq)

2.5E-03
4.2E-03

3.1E-03
5.4E-03

4.8E-03
7.7E-03

7.3E-03
1.1E-02

1.3E-02
1.9E-02

The effective dose resulting from an administered activity of 800 MBq Sodium Pertechnetate (99mTc) Injection is 10.4 mSv.
Following pre-treatment of patients with a blocking agent, administration of 800 MBq Sodium Pertechnetate (99mTc)
Injection results in an effective dose of 3.36 mSv.
(iii) The radiation doses absorbed by a patient following intravenous injection of technetium 99m labelled red
blood cells are as follows:
Organ
Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI tract
Stomach
SI
Colon
(ULI
(LLI

Adult
9.9E-03
8.5E-03
7.4E-03
3.6E-03
3.5E-03
6.5E-03

Absorbed dose per unit activity administered (mGy/MBq)
15 Year
10 Year
5 Year
1.2E-02
2.0E-02
3.0E-02
1.1E-02
1.4E-02
1.7E-02
1.2E-02
1.9E-02
3.6E-02
4.6E-03
7.5E-03
1.2E-02
4.1E-03
7.0E-03
1.1E-02
8.1E-03
1.3E-02
2.0E-02

1 Year
5.6E-02
3.1E-02
7.4E-02
2.2E-02
1.9E-02
3.0E-02

4.6E-03
3.9E-03
3.7E-03
4.0E-03
3.4E-03

5.9E-03
4.9E-03
4.8E-03
5.1E-03
4.4E-03

9.7E-03
7.8E-03
7.5E-03
8.0E-03
6.9E-03

1.4E-02
1.2E-02
1.2E-02
1.3E-02
1.0E-02

2.5E-02
2.1E-02
2.0E-02
2.2E-02)
1.8E-02)

Heart
Kidneys
Liver
Lungs
Muscles

2.3E-02
1.8E-02
1.3E-02
1.8E-02
3.3E-03

2.9E-02
2.2E-02
1.7E-02
2.2E-02
4.0E-03

4.3E-02
3.6E-02
2.6E-02
3.5E-02
6.1E-03

6.6E-02
5.7E-02
4.0E-02
5.6E-02
9.4E-03

1.1E-01
1.1E-01
7.2E-02
1.1E-01
1.7E-02

Oesophagus
Ovaries
Pancreas
Red marrow
Skin

6.1E-03
3.7E-03
6.6E-03
6.1E-03
2.0E-03

7.0E-03
4.8E-03
8.1E-03
7.6E-03
2.4E-03

9.8E-03
7.0E-03
1.3E-02
1.2E-02
3.8E-03

1.5E-02
1.1E-02
1.9E-02
2.0E-02
6.2E-03

2.3E-02
1.9E-02
3.3E-02
3.7E-02
1.2E-02

Spleen
Testes
Thymus
Thyroid
Uterus

1.4E-02
2.3E-03
6.1E-03
5.7E-03
3.9E-03

1.7E-02
3.0E-03
7.0E-03
7.1E-03
4.9E-03

2.7E-02
4.4E-03
9.8E-03
1.2E-02
7.4E-03

4.3E-02
6.9E-03
1.5E-02
1.9E-02
1.1E-02

8.1E-02
1.3E-02
2.3E-02
3.6E-02
1.9E-02

Remaining organs
Effective dose (mSv/MBq)

3.5E-03
7.0E-03

4.5E-03
8.9E-03

7.3E-03
1.4E-02

1.3E-02
2.1E-02

2.3E-02
3.9E-02

The effective dose resulting from an administration of 925 MBq technetium-99m labelled red blood cells is 5.78 mSv.
(iv) 
The radiation dose absorbed by the lens of the eye following administration of sodium [99mTc]pertechnetate for
lacrimal duct scintigraphy is estimated to be 0.038 mGy/MBq. This results in an effective dose of less than 0.01 mSv
for an administered activity of 4 MBq (ICRP 53, 1987).
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may 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 local competent official organisations (see section 6.6).
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination
from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must
therefore be taken.

Measure bar should be 150mm at 100% scale

Instructions for elution of the Drytec Generator
Safe handling
The weight of the generator depends on the shielding used. The approximate weights are:
45 mm lead shielded generator = 11 kg
54 mm lead shielded generator = 15 kg
Depleted uranium shielded generator = 17 kg
Consideration should be given to the safe lifting and carrying of the generators. Local manual handling operations
regulations should be observed in order to reduce the risk of injury caused by manual handling activities.
Elution instructions – please also refer to the adjacent diagrams
The facilities used for elutions should comply with the appropriate regulations for safe radiological handling. Strict
aseptic techniques should be used during the elution of the generator to ensure sterility of the generator eluate. To avoid
unsatisfactory performance it is important to adhere to the following sequence of elution steps.
First elution
Remove the generator and accompanying accessories from their packaging. Place the generator on a flat, level
(1) 
surface, in a suitably authorised and shielded location (Fig 1). Do not remove the spike and needle protectors until
you are ready to carry out the first elution.
(2) Select a saline vial containing the required volume of saline.
(3) 
Remove the flip-top from the saline vial and swab the saline vial closure using a supplied bactericidal swab and allow
to dry.
(4) Remove the spike protector ( Fig 2).
Place the saline vial onto the spike, ensuring that it is fully pushed to the bottom of the inlet well. Partial rotation will
(5) 
assist the positioning of the vial.
(6) 
Select an evacuated collection vial and swab the collection vial closure using a supplied bactericidal swab and allow
to dry. Prior to placing the collection vial inside the collection vial shield ensure that the vial contact surfaces of the
shield have been swabbed using the bactericidal swab provided. Replace the collection vial shield screwlocked cap
as shown (Fig 3). The collection shield push fit top is not required until the elution has been completed.
(7) 
Remove the collection point protector by turning it anti-clockwise (Fig 4). Ensure that the luer type filter attached to
the collection point protector is also removed. Retain the collection point protector for use when returning the
generator. Immediately fit a collection needle provided in the accessory pack (Fig 5). Do not remove the collection
needle sheath until you are ready to place the collection vial on the needle.
(8) 
Remove the collection needle sheath (Fig 6) and place the collection vial shield on to the collection needle, aligning
the side location into its guide, and the window to the front. Push down to ensure that the vial is fully located on the
collection needle (Fig 7).
(9) 
Allow at least 3 minutes for the elution to proceed to completion. Each elution is deemed complete when all vigorous
bubbling has ceased inside the collection vial. Do not remove either the saline vial or collection vial before the
elution is complete.
(10) 
Slowly remove the collection vial shield to prevent damage to the collection needle (Fig 8) and replace the push fit
top for added radiation protection.
(11) 
Select a new collection needle protector from the accessory pack and push on to the collection needle to preserve
sterility (Fig 8).
(12) Leave the empty saline vial in place until the next elution to preserve sterility (Fig 9).
Subsequent elutions
Using a new sanitised saline vial of the required volume repeat steps 5–12.
If the collection needle needs to be changed, simply remove the damaged needle and swab the collection well to ensure
sterility is maintained and fit a new needle. Place a collection needle protector over the new needle.
Following expiry, the generator should be returned according to the return instructions. A spare spike protector and the
retained collection point protector should be used to cover the spike and collection point respectively (Fig 10).

Figure. 2
Figure. 2

Figure. 1
Figure. 1

Figure. 4
Figure. 4

Figure. 3
Figure. 3

Table 2 Factors allowing for growth of technetium-99m at various times following the previous elution
(technetium-99m half-life 6.02 hours)
Hours
1
2
3
4
5
6
7
8

Factor
0.094
0.179
0.256
0.324
0.386
0.442
0.492
0.538

Hours
9
10
11
12
13
14
15
16

Factor
0.579
0.615
0.648
0.678
0.705
0.729
0.751
0.771

Hours
17
18
19
20
21
22
23
24

Factor
0.788
0.804
0.818
0.831
0.843
0.853
0.863
0.871

Hours
25
26
27
28
29
30
31
32

Factor
0.879
0.884
0.892
0.898
0.903
0.907
0.911
0.915

Hours
33
34
35
36
37
38
39
40

Factor
0.918
0.921
0.924
0.926
0.929
0.930
0.932
0.934

Hours
41
42
43
44
45
46
47
48

Factor
0.935
0.937
0.938
0.940
0.941
0.941
0.941
0.942

13 OTHER INFORMATION
Manufacturer
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
DRYTEC is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.

Figure. 5
Figure. 5

3 min

3 min

GE Healthcare GE Healthcare
Figure. 6
Figure. 6

Figure. 7
Figure. 7

Figure. 8
Figure. 8

Figure. 10
Figure. 10

Figure. 9
Figure. 9

Elution volume and yield of technetium-99m
Due to the elution characteristics of the different column designs, it is recommended that the minimum elution volume for
lead shielded generators is 5 ml. For depleted uranium shielded generators the minimum elution volume should be 10 ml.
If 5 ml elutions are used a higher radioactive concentration will be obtained, but a small yield reduction may be expected.
Drytec is calibrated in terms of the amount of molybdenum loaded on the column. The available technetium-99m at any
time depends on the time before or after reference (due to the decay of molybdenum-99, the time elapsed since the
previous elution (due to “growth” of technetium- 99m) and on the decay characteristics of molybdenum-99 (86.2% of all
decay yields technetium-99m). Factors listed in Tables 1 and 2 may be used to calculate the available technetium-99m
activity using the following method.
First, multiply the stated reference activity by the appropriate factor from Table 1(which allows for decay of
molybdenum-99). Then multiply the product by the appropriate factor from Table 2(which allows for the growth of
technetium-99m and for decay characteristics of molybdenum-99).
The actual yield of technetium-99m will vary slightly due to variation in elution efficiency from generator to generator.
It should typically be not less than 90% of the available technetium-99m activity.
Disposal of expired generators
Expired generators containing lead shielding should normally be disposed of by the user as radioactive waste in
accordance with the conditions specified by the local competent authority. If local regulations for disposal require
that the generator should be dismantled, please contact GE Healthcare Limited or its local representative. In certain
markets, arrangements may be made for the return of lead shielded generators to GE Healthcare Limited or its local
representative.
Generators containing depleted uranium and tungsten shielding must be returned to GE Healthcare Limited after expiry. Full
instructions describing how the return of generators to GE Healthcare Limited should be carried out are included with each
generator. Users are reminded that all packaging, documentation and methods of transportation used must be in compliance
with international transport regulations and all local regulations and codes of practice that relate to such matters.
Table 1 Molybdate-99 decay factors at various times from generator reference time (molybdate-99 half-life
66 hours)
GMT

Days from generator reference time

(hrs)

-10

-9

-8

-7

-6

-5

-4

-3

-2

-1

0

1

2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
20.00
22.00
24.00

13.8123
13.5252
13.2441
12.9688
12.6992
12.4353
12.1768
11.9237
11.6758
11.4332
11.1955
10.9628

10.7349
10.5118
10.2933
10.0794
9.8699
9.6647
9.4638
9.2671
9.0745
8.8859
8.7012
8.5203

8.3432
8.1698
8.0000
7.8337
7.6709
7.5114
7.3553
7.2024
7.0527
6.9061
6.7626
6.6220

6.4844
6.3496
6.2176
6.0884
5.9618
5.8379
5.7166
5.5978
5.4814
5.3675
5.2559
5.1467

5.0397
4.9349
4.8324
4.7319
4.6336
4.5373
4.4429
4.3506
4.2602
4.1716
4.0849
4.0000

3.9169
3.8354
3.7557
3.6777
3.6012
3.5264
3.4531
3.3813
3.3110
3.2422
3.1748
3.1088

3.0442
2.9809
2.9190
2.8583
2.7989
2.7407
2.6837
2.6280
2.5733
2.5198
2.4675
2.4162

2.3660
2.3168
2.2686
2.2215
2.1753
2.1301
2.0858
2.0425
2.0000
1.9584
1.9177
1.8779

1.8388
1.8006
1.7632
1.7265
1.6906
1.6555
1.6211
1.5874
1.5544
1.5221
1.4905
1.4595

1.4291
1.3994
1.3704
1.3419
1.3140
1.2867
1.2599
1.2337
1.2081
1.1830
1.1584
1.1343

1.1107
1.0876
1.0650
1.0429
1.0212
1.0000
0.9792
0.9589
0.9389
0.9194
0.9003
0.8816

0.8633
0.8453
0.8278
0.8105
0.7937
0.7772
0.7610
0.7452
0.7297
0.7146
0.6997
0.6852

GMT

Days from generator reference time

(hrs)

2

3

4

5

6

7

8

9

10

11

12

13

14

2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
20.00
22.00
24.00

0.6709
0.6570
0.6433
0.6300
0.6169
0.6040
0.5915
0.5792
0.5672
0.5554
0.5438
0.5325

0.5215
0.5106
0.5000
0.4896
0.4794
0.4695
0.4597
0.4502
0.4408
0.4316
0.4227
0.4139

0.4053
0.3969
0.3886
0.3805
0.3726
0.3649
0.3573
0.3499
0.3426
0.3355
0.3285
0.3217

0.3150
0.3084
0.3020
0.2957
0.2896
0.2836
0.2777
0.2719
0.2663
0.2607
0.2553
0.2500

0.2448
0.2397
0.2347
0.2299
0.2251
0.2204
0.2158
0.2113
0.2069
0.2026
0.1984
0.1943

0.1903
0.1863
0.1824
0.1786
0.1749
0.1713
0.1677
0.1642
0.1608
0.1575
0.1542
0.1510

0.1479
0.1448
0.1418
0.1388
0.1360
0.1331
0.1304
0.1277
0.1250
0.1224
0.1199
0.1174

0.1149
0.1125
0.1102
0.1079
0.1057
0.1035
0.1013
0.0992
0.0972
0.0951
0.0932
0.0912

0.0893
0.0875
0.0856
0.0839
0.0821
0.0804
0.0787
0.0771
0.0755
0.0739
0.0724
0.0709

0.0694
0.0680
0.0666
0.0652
0.0638
0.0625
0.0612
0.0599
0.0587
0.0575
0.0563
0.0551

0.0540
0.0528
0.0517
0.0507
0.0496
0.0486
0.0476
0.0466
0.0456
0.0447
0.0437
0.0428

0.0419
0.0411
0.0402
0.0394
0.0386
0.0378
0.0370
0.0362
0.0354
0.0347
0.0340
0.0333

0.0326
0.0319
0.0313
0.0306
0.0300
0.0293
0.0287
0.0281
0.0275
0.0270
0.0264
0.0259

HEALTHCARE PROFESSIONAL
INFORMATION

Drytec™

2.5-100 GBq
radionuclide generator
Sodium [99mTc]
pertechnetate
MCD
9 9 9 9 9 9 9

L/5976/02

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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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