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STABILISED CERETEC 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): EXAMETAZIME

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Package leaflet: Information for the patient
Stabilised Ceretec 500 micrograms kit for
radiopharmaceutical preparation
Exametazime
(called Stabilised Ceretec in this leaflet)
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.
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 Stabilised Ceretec is and what it is used
for
2. What you need to know before Stabilised
Ceretec is used
3. How Stabilised Ceretec is used
4. Possible side effects
5. How Stabilised Ceretec is stored
6. Contents of the pack and other information
1. What Stabilised Ceretec is and what it is
used for

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Stabilised Ceretec is a radiopharmaceutical
product for diagnostic use only. It is used only
to help identify illness.
Stabilised Ceretec is given before a scan and
helps a special camera see inside a part of your
body.

• It contains an active ingredient called
‘exametazime’. This is mixed with another
ingredient called ‘technetium’ before it is used.
• Once injected it can be seen from outside your
body by a special camera used in the scan.
• The scan can help your doctor see how much
blood is flowing through your brain. This may
be important to know after a stroke, if you have
fits or epilepsy, Alzheimer’s disease or a similar
type of dementia. It may also be used in people
who have migraine (headaches) or a brain
tumour
The use of Stabilised Ceretec involves exposure
to small amounts of radioactivity. Your doctor
and the nuclear medicine doctor have considered
that the clinical benefit of this procedure with the
radiopharmaceutical outweighs the risk of being
exposed to these small amounts of radiation.
Ask your nuclear medicine doctor if you have any
questions.
2. What you need to know before Stabilised
Ceretec is used
Stabilised Ceretec must not be used:
• if you are allergic (hypersensitive) to the active
ingredient or any other ingredients of this
medicine. (listed in Section 6).
Warnings and precautions
Talk to your nuclear medicine doctor before using
Stabilised Ceretec
• if the person who will be given this medicine
is a child.
• if you are pregnant or think you may be
pregnant.
• if you are breast feeding.
• if you are on a low sodium diet.
Children and adolescents
Stabilised Ceretec is not recommended for
administration to children.

Other medicines and Stabilised Ceretec
Tell your nuclear medicine doctor who will
supervise the procedure if you are taking, have
recently taken or might take any other medicines
since they may affect the way Stabilised Ceretec
works.
No medicines have been reported that affect the
way Stabilised Ceretec works. But it is still best
to tell your doctor or nurse if you are taking any
other medicines.

Driving and using machines
It is considered unlikely that Stabilised Ceretec
will affect your ability to drive or to use machines.
Ask your nuclear medicine doctor if you can
drive or use machines after you have been given
Stabilised Ceretec.

Pregnancy and breast-feeding
You must tell your nuclear medicine doctor
before you are given Stabilised Ceretec if there
is a possibility you might be pregnant, if you have
missed your period or 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 give
this medicine during pregnancy if a benefit is
expected which would outweigh the risk.
If you are breast-feeding
Do not breast-feed if you are given Stabilised
Ceretec. 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 using Stabilised Ceretec. If it is not
possible to wait, your nuclear medicine doctor will
ask you to:
• stop breast-feeding for 12 hours or longer, and
• use formula feed for your child, and
• express (remove) breast milk and throw away
the milk.
Your nuclear medicine doctor will let you know
when you can start breast-feeding again.

3. How Stabilised Ceretec is used

Stabilised Ceretec contains sodium
1.77 mg per vial. This should be considered for
patients on a controlled sodium diet.
There are strict laws on the use, handling and
disposal of radiopharmaceutical products.
Stabilised Ceretec will only be handled and given
to you by professionals who are trained and
qualified to use it safely.
Before administration of Stabilised Ceretec you
should
Drink plenty of water before the start of the
examination in order to urinate as often as
possible during the first hours after the scan.
Administration of Stabilised Ceretec and
conduct of the procedure
Dose
The nuclear medicine doctor supervising the
procedure will decide on the amount of Stabilised
Ceretec to be used in your case. The doctor will
choose the smallest amount necessary to get the
desired information.
The amount to be administered usually
recommended for an adult ranges from 350 to
500 MBq for brain scintigraphy. Megabecquerel
(MBq) is the unit used to express radioactivity

One injection is sufficient to carry out the scan
that your doctor needs.
• Stabilised Ceretec will always be used in
a hospital or clinic.
• Stabilised Ceretec will be given to you by
a specially trained and qualified person.
• They will provide you with the necessary
information on the procedure
Duration of the procedure
Your nuclear medicine doctor will inform you
about the usual duration of the procedure.
After administration of Stabilised Ceretec you
should:
• 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 are given more Stabilised Ceretec than
you should
An overdose is unlikely because you will only
receive a single dose of Stabilised Ceretec
precisely controlled by the nuclear medicine
doctor supervising the procedure. However, in
the case of an overdose, you would receive the
appropriate treatment.
If you have any further questions on the use of
this medicine, please ask your nuclear medicine
doctor who supervises the procedure.

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Allergic reactions
Tell your doctor straight away if you have an
allergic reaction when you are in hospital or
a clinic having the scan. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing.
If any of the side effects above happen after you
leave the hospital or clinic, go straight to the
casualty department of your nearest hospital.
Other side effects include:(frequency not known)
• itchy lumpy rash
• headache
• feeling dizzy
• flushing
• feeling sick (nausea)
• being sick (vomiting)
• general feeling of being unwell, weak or tired
• unusual feelings of numbness, tingling, prickling
burning or creeping on skin.
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 Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How Stabilised Ceretec 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.

Hospital staff will ensure that the product is
stored and disposed of correctly and not used
after the expiry date stated on the label.
The following information is intended for
healthcare or medical professionals only.
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which are stated on the label after ‘EXP’.
• Store the stabilised reconstituted product below
25°C. Do not freeze
• The stabilised product must be injected
between 30 minutes and 5 hours after
preparation
6. Contents of the pack and other information
What Stabilised Ceretec contains
• The active ingredient is exametazime. Each vial
of Stabilised Ceretec contains 500 micrograms
of exametazime.
• The other ingredients are stannous chloride
dihydrate, sodium chloride, cobalt (II) chloride
6-hydrate and water for injections.
What Stabilised Ceretec looks like and contents
of the pack
Stabilised Ceretec is supplied as a kit for
radiopharmaceutical preparation. The kit
contains:
• two vials containing 500 micrograms
exametazime and two vials of a solution for
injection, or
• five vials containing 500 micrograms
exametazime and five vials of a solution for
injection.
Not all pack sizes may be marketed.

Marketing
Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire
HP7 9NA
United Kingdom
Manufacturer
GE Healthcare AS
Nycoveien 1-2
0401 OSLO
Norway

GE Healthcare

PATIENT
INFORMATION

Stabilised Ceretec™
500 micrograms kit for
radiopharmaceutical
preparation
Exametazime

This leaflet was last
revised in February
2017.
Marketing
Authorisation
UK: PL 00221/0136
Stabilised Ceretec
is a trademark of
GE Healthcare.
GE and the
GE Monogram are
trademarks of General
Electric Company.

1189017

1189017 GBR

Document: 1189018 GBR Version: 0

PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
1 Name of the medicinal product
Stabilised Ceretec 500 micrograms kit for radiopharmaceutical preparation
2 Qualitative and Quantitative Composition
Each vial contains exametazime 500 micrograms.
Stabilised Ceretec is reconstituted with Sodium Pertechnetate (99mTc)
Injection Ph.Eur. (not included in this kit) to prepare stabilised Technetium
(99mTc) Exametazime Injection.
Excipients with known effect
The product before reconstitution contains sodium: 1.77 mg/vial. 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
Kit for radiopharmaceutical preparation for injection.
A white powder.
4 Clinical Particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (99mTc) Injection, the
product is indicated in adults for:
Technetium-99m exametazime injection is indicated for brain scintigraphy.
The product is to be used for the diagnosis of abnormalities of regional
cerebral blood flow, such as those occurring following stroke and other
cerebrovascular disease, epilepsy, Alzheimer’s Disease and other forms of
dementia, transient ischaemic attack, migraine and tumours of the brain.
4.2 Posology and method of administration
Posology
Adults and the elderly population
350-500 MBq by direct intravenous injection.
Normally a once-only diagnostic procedure.
Paediatric population
Technetium-99m exametazime is not recommended for administration to
children.
Method of administration
This medicinal product should be reconstituted before administration to
the patient.
For instructions on reconstitution of the medicinal product before
administration, see section 12.
For patient preparation, see section 4.4
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.
4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
The possibility of hypersensitivity including anaphylactic/anaphylactoid reactions
should always be considered. If hypersensitivity or anaphylactic reactions occur,
the administration of the medicinal product must be discontinued immediately

and intravenous treatment initiated, if necessary. To enable immediate action
in emergencies, the necessary medicinal products and equipment such as
endotracheal tube and ventilator must be immediately available.
Individual benefit/risk justification
For each patient, exposure to ionising radiation must be justifiable on the
basis of likely benefit. The activity administered should in every case be as
low as reasonably achievable to obtain the required diagnostic information.
Renal impairment and hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required
since an increased radiation exposure is possible.
Paediatric population
Paediatric population, see section 4.2
Patient preparation
The patient should be well hydrated before the start of the examination
and urged to void as often as possible during the first hours after the
examination in order to reduce radiation.
Specific warnings
Depending on the time when you administer the injection, the content of
sodium given to the patient may in some cases be greater than 1 mmol.
This should be taken into account in patients on low sodium diet.
Precautions with respect to environmental hazard see section 6.6.
4.5 Interaction with other medicinal products and other forms of
interaction
No interaction studies have been performed and no drug interactions
have been reported to date.
4.6 Fertility, pregnancy and lactation
Women with 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
No data are available on the use of this product in human pregnancy.
Animal reproduction studies have not been performed.
Radionuclide procedures carried out on pregnant women also involve
radiation doses to the foetus. Only essential investigations should therefore
be carried out during pregnancy, when the likely benefit far exceeds the
risk incurred by the mother and the foetus.
Breast-feeding
Before administering a radioactive medicinal product to a mother who is
breast feeding consideration should be given as to whether the investigation
could be reasonably delayed until after the mother has ceased breast feeding
and as to whether the most appropriate choice of radiopharmaceutical has
been made, bearing in mind the secretion of activity in breast milk. If the
administration is considered necessary, breast feeding should be interrupted
for 12 hours and the expressed feeds discarded.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have
been performed.

4.8 Undesirable effects
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
Not known: Hypersensitivity including rash, erythema, urticaria,
angiooedema, pruritus
Nervous system disorders
Not known: Headache, dizziness, paraesthesia
Vascular disorders
Not known: Flushing
Gastrointestinal disorders
Not known: Nausea, vomiting
General disorders and administration site conditions
Not known: Asthenic conditions (e.g., malaise, fatigue)
Exposure to ionising radiation is linked with cancer induction and a potential
for development of hereditary defects. As the effective dose is 5.2 mSv
when the maximal recommended activity of 555 MBq is administered these
adverse events 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 Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
4.9 Overdose
In the event of the administration of a radiation overdose frequent
micturition and defaecation should be encouraged in order to minimise
the absorbed dose to patient.
5 Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceutical for central
nervous system, technetium (99mTc) exametazine, ATC Code: V09AA01.
At the chemical concentrations and activities used for diagnostic
procedures technetium-99m exametazime does not appear to exert any
pharmacodynamic effects.
5.2 Pharmacokinetic properties
The technetium-99m complex of the active ingredient is uncharged, lipophilic
and of sufficiently low molecular weight to cross the blood-brain barrier. It is
rapidly cleared from the blood after intravenous injection. Uptake in the brain
reaches a maximum of 3.5-7.0% of the injected dose within one minute of
injection. Up to 15% of the cerebral activity washes out of the brain 2 minutes
post injection after which there is little loss of activity for the following 24 hours
except by physical decay of technetium-99m. The activity not associated with
the brain is widely distributed throughout the body particularly in muscle and
soft tissue. About 20% of the injected dose is removed by the liver immediately
after injection and excreted through the hepatobiliary system. About 40% of the
injected dose is excreted through the kidneys and urine over the 48 hours after
injection resulting in a reduction in general muscle and soft tissue background.
In vitro stabilisation of technetium-99m exametazime injection with cobalt (II)
chloride does not appear to affect the in vivo pharmacokinetics of the complex.

5.3 Preclinical safety data
There are no additional preclinical safety data of relevance concerning
exametazime for the prescriber in recognising the safety profile of the
product used for the authorised indication.
There are no indications that the gross toxicity profile of the stabilised
formulation of technetium-99m exametazime is significantly different from
that of the non-stabilised formulation.
In vitro mutagenicity studies indicate that the stabilised formulation of
technetium-99m exametazime is weakly mutagenic in the Ames (bacterial
mutation) test, human lymphocyte chromosome aberration assay and
mouse lymphoma thymidine kinase assay. The stabilised formulation is
found not to be mutagenic in two in vivo assays (rat bone marrow
micronucleus and rat liver micronucleus).
At quantities such as those encountered in stabilised technetium-99m
exametazime preparations, cobalt (II) ions or complexed forms of cobalt
have no known adverse effects and are rapidly eliminated from the
circulation by urinary excretion.
6 Pharmaceutical particulars
6.1 List of excipients
The finished product contains the following excipients:
Ceretec component:
• Sodium chloride Ph.Eur
• Stannous chloride dihydrate Ph.Eur
Cobalt stabiliser solution:
• Cobalt (II) chloride 6-hydrate
• Water for injections Ph.Eur
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 12.
6.3 Shelf life
26 weeks from the day of manufacture. The stabilised product must be
injected between 30 minutes and 5 hours after preparation.
The stabilised reconstituted product should be stored below 25°C. Do not
freeze.
6.4 Special precautions for storage
For storage conditions after reconstitution of the medicinal product, see
section 6.3.
Storage should be in accordance with national regulations for radioactive
materials.
6.5 Nature and contents of container
The freeze-dried component of the product is supplied in a glass vial
sealed with a chlorobutyl rubber closure and aluminium overseal and blue
flip off cap. The cobalt stabiliser solution is supplied in a glass vial with a
chlorobutyl rubber closure and metal overseal.
Pack sizes: each kit contains 2 or 5 vials.
Not all pack sizes may be marketed.
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. Its 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) exametazime injection and are not to be administered
directly to the patient without first undergoing the preparative procedure.
For instructions on reconstitution 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 reconstitution is not radioactive. However,
after sodium pertechnetate (99mTc), Ph. Eur. is added, adequate shielding of
the final preparation must be maintained.
The administration of radiopharmaceuticals creates risks for other persons
from external radiation or contamination from spill of urine, vomiting etc.
Radiation protection precautions in accordance with national regulations
must therefore be taken.
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 local requirements.
7 Marketing Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
8 Marketing Authorisation Number
UK: PL 00221/0136
9 Date of First authorisation/Renewal of the authorisation

UK

Date of first authorisation

Date of last renewal

09 November 1999

29 November 2003

Document: 1189018 GBR Version: 0

10 Date of Revision of the text
August 2016
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 table below shows the dosimetry as calculated according to the
Publication ICRP 62 (International Commission on Radiological Protection,
Radiological Protection in Biomedical Research, Pergamon Press 1991).

Organ

Absorbed dose
per unit activity administered (mGy/MBq)
Adult

Adrenals
Bladder
Bone surfaces
Brain
Breast
Gall bladder
GI tract
Stomach
SI
ULI
LLI

5.3E-03
2.3E-02
5.1E-03
6.8E-03
2.0E-03
1.8E-02

Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas

3.7E-03
3.4E-02
8.6E-03
1.1E-02
2.8E-03
2.6E-03
6.6E-03
5.1E-03

Red marrow
Skin
Spleen
Testes
Thymus
Thyroid
Uterus

3.4E-03
1.6E-03
4.3E-03
2.4E-03
2.6E-03
2.6E-02
6.6E-03

Remaining organs

3.2E-03

Effective dose
(mSv/MBq)

9.3E-03

6.4E-03
1.2E-02
1.8E-02
1.5E-02

Effective Dose is 4.7 mSv/500 MBq (70 kg individual).
The biodistribution and hence the radiation dosimetry of technetium-99m
exametazime is not significantly altered by in vitro cobalt stabilisation.
12 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.
Method of preparation of cobalt stabilised technetium-99m
exametazime for intravenous injection:
Use aseptic technique throughout.
(1) Place the exametazime vial in a shielding container and swab the
closure with the sanitising swab provided.
(2) Using a 10 ml syringe, inject into the shielded vial 5 ml of sterile eluate
from a technetium-99m generator (see notes 1 - 6). Before withdrawing
the syringe from the vial withdraw 5 ml of gas from the space above
the solution to normalise the pressure in the vial. Shake the shielded
vial for 10 seconds to ensure complete dissolution of the powder.

(3) Between 1 and 5 minutes after reconstitution, inject 2 ml of cobalt
stabiliser solution into the shielded vial using a 3 ml syringe. Before
withdrawing the syringe from the vial, withdraw 2 ml of gas from the
space above the solution to normalise the pressure in the vial. Shake
the shielded vial for 10 seconds to ensure complete mixing.
(4) Assay the total radioactivity and calculate the volume to be injected.
(5) Complete the label provided and attach to the vial.
(6) Use the stabilised product between 30 minutes and 5 hours after
preparation. Individual patient doses may be stored aseptically in a
capped syringe if required (see note 7).
(7) Discard any unused material.
Note:
(1) For the highest radiochemical purity reconstitute with freshly eluted
technetium-99m generator eluate.
(2) The technetium-99m generator eluate must be used within 4 hours of
elution from a generator that has already been eluted within the
previous 24 hours.
(3) 0.37 - 1.11 GBq technetium-99m may be added to the vial.
(4) Before reconstitution the generator eluate may be adjusted to the
correct radioactive concentration (0.37 - 1.11 GBq in 5 ml) by dilution
with sodium chloride for injection.
(5) [99mTc]pertechnetate complying with the specifications prescribed by
the USP and BP/Ph.Eur. Monographs on Sodium Pertechnetate (99mTc)
Injection should be used.
(6) The cobalt stabilised technetium-99m exametazime is a pale strawcoloured solution and the pH is in the range 5.0 - 8.0.
(7) When Stabilised Ceretec preparations are transferred to individual
patient syringes, a small volume of the headspace gas must be
withdrawn from the vial into the syringe after solution transfer to
ensure that no solution remains in contact with the syringe needle
prior to administration to the patient.
(8) The shelf life of the reconstituted Ceretec component without the
addition of the cobalt stabiliser is only 30 minutes.
Quality Control
Three potential radiochemical impurities may be present in prepared Technetium
(99mTc) Exametazime Injection. These are a secondary 99mTc-exametazime
complex, free [99mTc]pertechnetate and reduced-hydrolysed-technetium-99m.
A combination of two chromatographic systems is necessary for the determination
of the radiochemical purity of the injection.
Test samples are applied by needle approximately 2.5 cm from the bottom
of two Glass Microfiber Chromatography Paper impregnated with Silicic Acid
(GMCP-SA) strips (2 cm (±2 mm)x 20 cm). The strips are then immediately placed
in prepared ascending chromatography development tanks, one containing
butan-2-one and the other 0.9% sodium chloride (1 cm depth fresh solvent).
After a 15 cm. elution the strips are removed, solvent fronts marked, the strips
dried and the distribution of activity determined using suitable equipment.
Interpretation of chromatograms
System 1 (GMCP-SA:butan-2-one(methyl ethyl ketone))
Secondary 99mTc-exametazime complex and reduced-hydrolysedtechnetium-99m remain at the origin.
Lipophilic 99mTc-exametazime complex and [99mTc]pertechnetate migrate
at Rf 0.8-1.0.

System 2 (GMCP-SA:0.9% sodium
chloride)
Lipophilic 99mTc-exametazime
complex, secondary 99mTcexametazime complex and
reduced-hydrolysed technetium99m remain at the origin.
[99mTc]pertechnetate migrates at
Rf 0.8-1.0.
I. Calculate the percentage of
activity due to both secondary
99mTc exametazime complex
and reduced-hydrolysedtechnetium-99m from
System 1 (A%). Calculate the
percentage of activity due to
[99mTc]pertechnetate from
System 2 (B%).
II. The radiochemical
purity (as percentage
lipophilic technetium-99m
exametazime complex) is
given by:
100-(A%+B%) where:
A% represents the level
of secondary technetium99m exametazime complex
plus reduced-hydrolysed
technetium-99m.
B% represents the level of
[99mTc]pertechnetate.
A radiochemical purity of at
least 80% may be expected
provided the test samples have
been taken and analysed within
5 hours of the preparation of
the stabilised product.
13 OTHER INFORMATION
Manufacturer
GE Healthcare AS
Nycoveien 1-2
0401 Oslo
Norway
Ceretec is a trademark of GE
Healthcare.
GE and the GE Monogram are
trademarks of General Electric
Company.

GE Healthcare

HEALTHCARE PROFESSIONAL
INFORMATION

Stabilised Ceretec™
500 micrograms kit for
radiopharmaceutical
preparation
Exametazime

1189018 GBR

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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