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CHROMIUM (51CR) EDTA 3.7 MBQ/ML SOLUTION FOR INJECTION

Active substance(s): CHROMIUM EDETATE (51CR) / CHROMIUM EDETATE (51CR) / CHROMIUM EDETATE (51CR)

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Chromium (51Cr) EDTA 3.7 MBq/ml solution for injection
(called Chromium EDTA Injection in this leaflet)
Chromium-51 edetate
Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your nuclear
medicine doctor who will supervise the procedure.
• If you get any side effects, talk to your nuclear
medicine doctor. This includes any side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Chromium EDTA Injection is and what it is used
for
2. What you need to know before Chromium EDTA
Injection is used
3. How Chromium EDTA Injection is used
4. Possible side effects
5. How Chromium EDTA Injection is stored
6. Contents of the pack and other information
1. What Chromium EDTA Injection is and what it is
used for
This medicine is a radiopharmaceutical product for
diagnostic use only. It is used only to help identify illness.
Chromium EDTA Injection is given before a scan and
helps a special camera see inside a part of your body.
• It contains an active ingredient called ‘chromium
edetate’.

• 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 well your
kidneys are working.
The use of Chromium EDTA Injection does involve
exposure to small amounts of radioactivity. Your doctor
and the nuclear medicine doctor have considered
that the clinical benefit that you will obtain from the
procedure with the radiopharmaceutical outweighs the
risk due to radiation.
2. What you need to know before Chromium EDTA
Injection is used
Chromium EDTA Injection must not be used:
• If you are allergic (hypersensitive) to Chromium
EDTA Injection or any of the other ingredients of this
medicine (listed in section 6).
Premature babies or newborn babies (neonates) must
not be given Chromium EDTA Injection. (See “Important
information about some of the ingredients of Chromium
EDTA Injection”).
Warnings and precautions
Talk to your nuclear doctor who is conducting the
investigation before you are given Chromium EDTA
Injection.
Take special care with Chromium EDTA Injection
Talk to your nuclear medicine doctor before having
Chromium EDTA Injection:
• If you are pregnant or believe you may be pregnant.
• If you are breastfeeding
• If you are on a low sodium diet. This medicinal product
contains 0.23 mg Sodium per ml. To be taken into
consideration by patients on a controlled sodium diet
Before administration of Chromium EDTA Injection 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 study.
Children and adolescents
Talk to your nuclear medicine doctor if you are under
18 years old.
Other medicines and Chromium EDTA Injection.
Tell your nuclear medicine doctor if you are taking or
have recently taken or might take any other medicines,
since they might interfere with the interpretation of
images.
No medicines have been reported that affect the way
Chromium EDTA Injection works. But it is still best to tell
your nuclear medicine doctor if you are taking any other
medicines.
Having Chromium EDTA Injection with food and drink
• Your doctor may recommend that you drink plenty of
fluids and pass water (urinate) as often as possible in
the hours after the injection.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask your
nuclear medicine doctor for advice before you are given
this medicine.
You must inform the nuclear medicine doctor before the
administration of Chromium EDTA Injection if there is a
possibility you might be pregnant, if you have missed
your period or if you are breastfeeding.
When in doubt, it is important to consult your nuclear
medicine doctor who will supervise the procedure.
If you are pregnant
You must tell your nuclear medicine doctor if you are
pregnant or think you may be pregnant. Your nuclear
medicine doctor will only administer this product during
pregnancy if a benefit is expected which would outweigh
the risks.

If you are breastfeeding
Do not breastfeed if you are given Chromium
EDTA Injection. This is because small amounts of
‘radioactivity’ may pass into the mother’s milk. If you
are breastfeeding, your nuclear medicine doctor may
wait until you have finished breastfeeding before using
Chromium EDTA Injection. If it is not possible to wait
your nuclear medicine doctor may ask you to:
• stop breastfeeding for 4 hours, 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
start breastfeeding again.
Driving and using machines
Ask your doctor if you can drive or use machines after
you have been given Chromium EDTA Injection.
Important information about some of the ingredients
of Chromium EDTA Injection
• Chromium EDTA Injection contains benzyl alcohol.
Benzyl alcohol may cause toxic reactions and allergic
reactions in infants and children up to 3 years old.
Important information about Chromium EDTA
Injection
When Chromium EDTA injection 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.
3. How Chromium EDTA Injection is used
There are strict laws on the use, handling and disposal
of radiopharmaceutical products. Chromium EDTA
Injection will only be used in special
turn over ➤

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 Chromium EDTA Injection
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 is one capsule and the maximal
recommended activity is 1.1 – 6.0 MBq (megabecquerel,
the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be
administered will be adapted to the child’s weight.
Administration of Chromium EDTA Injection and
conduct of the procedure
Chromium EDTA Injection is administered by one single
intravenous injection or single injection followed by a
type of drip called a slow infusion.
One injection is sufficient to conduct the test that your
doctor needs.
After injection, you will be offered a drink and asked to
urinate immediately preceding the test.
Use in adults and the elderly
• The normally recommended dose is 1.1-6.0 MBq.
Duration of the procedure
Your nuclear medicine doctor will inform you about the
usual duration of the procedure.
After administration of Chromium EDTA Injection, 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 have been given more Chromium EDTA Injection
than you should:
An overdose is unlikely because you will only receive
a single dose of Chromium EDTA Injection precisely
controlled by the nuclear medicine doctor supervising
the procedure. However, in the case of overdose, you
will receive the appropriate treatment.
Should you have any further questions on the use
of Chromium EDTA Injection, please ask the nuclear
medicine who supervises the procedure.
Samples that may be required after you have had
Chromium EDTA Injection
• Samples of your blood will be collected, possibly for
up to 24 hours, after the injection.
• Samples of your urine may be collected.
4. Possible side effects
Like all medicines, Chromium EDTA Injection can
cause side effects: for example, fainting, although not
everybody gets them.
This radiopharmaceutical will deliver low amounts of
ionising radiation associated with the least risk of cancer
and hereditary abnormalities.
Allergic reactions
If you have an allergic reaction when you are in hospital
or a clinic having the scan, tell the nuclear medicine
doctor straight away. 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.
Reporting of side effects
If you get any of the 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 Website:
www.mhra.gov.uk/yellowcard. By reporting side effects,
you can help provide more information on the safety of
this medicine.
5. How Chromium EDTA Injection 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 regulations on
radioactive materials.
The following information is intended for the specialist
only.
• Keep this medicine out of the sight and reach of
children
• Chromium EDTA Injection must not be used after the
expiry date which is stated on the label after ‘EXP’
• Chromium EDTA solution must not be used if it is
noticed that the vial is damaged
6. Contents of the pack and other information
What Chromium EDTA Injection contains
• The active ingredient is chromium-51 edetate.
Each ml of Chromium (51Cr) EDTA contains 3.7 MBq
(Megabecquerel – the unit in which radioactivity is
measured) of chromium-51edetate as an aqueous
solution.
• The other ingredients are disodium EDTA, benzyl
alcohol and water for injections.

What Chromium EDTA
Injection looks like and
contents of the pack
Chromium EDTA Injection
is supplied in a 10ml
colourless glass vial
containing a clear, violet
solution for injection.
One vial solution
contains 370 MBq
(megabecquerels, the
unit used to express
radioactivity).
Marketing Authorisation
Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire
HP7 9NA
United Kingdom
Manufacturer
GE Healthcare Limited
The Grove Centre
White Lion Road
Buckinghamshire
HP7 9LL
United Kingdom
This leaflet was last
revised in December
2016

GE Healthcare

PATIENT
INFORMATION

Chromium (51Cr)
EDTA
3.7 MBq/ml solution for
Injection
Chromium-51 edetate
CJ13P
9 9 9 9 9 9 9

P/5873/03

Marketing
Authorisations
UK: PL 00221/0108
GE and the GE
Monogram are
trademarks of General
Electric Company.

HEALTHCARE PROFESSIONAL LEAFLET
1
NAME OF THE MEDICINAL PRODUCT
Chromium (51Cr) EDTA 3.7 MBq/ml solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chromium-51 edetate 3.7 MBq/ml (37 MBq/vial) at the activity reference
date.
The formulation contains 0.64 mg/ml chromium edetate. Chromium-51
has a physical half-life of approximately 28 days and decays by gamma
emission with a principal energy of 0.32 MeV.
Excipient(s) with known effect
This medicinal product contains:
• Sodium: 0.23 mg/ml.
• Benzyl Alcohol: 10 mg/ml
For a full list of the excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, violet solution.

toxic reactions and anaphylactoid reactions in infants and children up to
3 years old.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely
benefit. The activity administered should in every case be as low as
reasonably achievable to obtain the required diagnostic information.
Renal/Hepatic impairment
Chromium (51Cr) EDTA injection has not been studied in patients with
significant renal or hepatic impairment. Careful consideration of the
benefit risk ratio in these patients is required since an increased radiation
exposure is possible.
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 the radiation dose to the bladder and an
accumulation of radioactivity in it.
Specific warnings
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially sodium free.
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.

4

CLINICAL PARTICULARS

4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
Chromium (51Cr) EDTA is indicated for the determination of glomerular
filtration rate in the assessment of renal function.
4.2 Posology and method of administration
Posology
Adults and elderly:
The normally recommended dose for adults and the elderly is 1.1-6.0 MBq
by intravenous injection or continuous infusion based on the average
patient weight of 70kg. The actual activity administered will depend on
the technique used to determine the renal clearance and on that used for
radioactivity detection. Higher activities up to a maximum of 11 MBq may
be appropriate for use in conjunction with external counting techniques.
Paediatric population:
The use in children and adolescents has to be considered carefully, based
upon clinical needs and assessing the risk/benefit ratio in this patient
group. The activity to be administered to children and to adolescents may
be calculated approximately by correcting on a weight, body surface
area or age basis the activity to adults. For children under about one
year of age, the target organ size in relation to the whole body must also
be taken into consideration. The maximal activity to be used in children
must not exceed 3.7 MBq.
Chromium (51Cr) EDTA Injection contains benzyl alcohol. It must not be
given to premature babies or neonates.
Renal/Hepatic impairment:
Chromium (51Cr) EDTA injection has not been studied in patients with
significant renal or hepatic impairment. Careful consideration of the
activity to be administered is required since an increased radiation
exposure is possible in these patients.
Method of administration
The following methods of administration are recommended:
Single intravenous injection
Because of the complexities of the infusion technique (see below) a
single injection technique is normally used. This method obviates the
need for urine collection. However, it is not suitable for use with patients
with oedema since in such patients equilibration of the administered
chromium-51 edetate between the plasma and interstitial fluid may take
up to 12 hours.
The single injection plasma clearance is calculated from the injected
amount of chromium-51 edetate and the decrease of activity in plasma
samples as a function of time. A number of different methods are
available for analysis of the plasma disappearance curve, one of which
is presented below.
A single intravenous administration of 3.7 MBq of chromium-51 edetate
is given. Venous samples are taken at appropriate intervals (for example,
two, three, and four hours after administration) with another at 24 hours if
renal failure is suspected. The venous samples are spun and the plasma
separated and counted, together with an aliquot of the given dose. The
net plasma activities are then expressed in terms of fractional dose and
plotted against time on a log-linear plot. A regression line is then fitted to
the data and the line extrapolated back to the ordinate axis. The turnover
rate k is determined from the slope of the line. The apparent distribution
volume of the tracer V is obtained by dividing the count rate due to the
administered dose by the plasma concentration given by the intercept on
the ordinate axis. The plasma clearance C is then given by:
C = kV
In order to correlate the chromium-51 edetate values with standard inulin
clearance values, a correction factor may be applied to the final result if
this is required.
Continuous intravenous infusion
A priming administration of 1.85 MBq is given intravenously followed
by the infusion of a solution containing 37 kBq/ml at a rate of 0.5 ml/
minute. After about 40 minutes, the plasma concentration becomes
constant. A urine collection lasting about 15 minutes is then started and
a venous sample taken at the mid-time. This process is repeated with
rapid separation and counting of the plasma radioactivity until constant
plasma activity is observed in two successive samples. The values of
the urine and the plasma concentrations and the urine flow are then
substituted into the equation:
C = UV
P
(where C = vol. of plasma cleared per unit time, U = urine concentration,
V = urinary flow, P = plasma concentration) to give the clearance. When
the urinary flow is low, it may be necessary to catheterise the bladder
in order to remove the whole of the urine sample for a particular time
period.
Alternative methods for determining glomerular filtration rate (GFR) using
chromium-51 edetate may be used in certain centres.
For instructions on preparation 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.
Must not be given to premature babies or neonates.
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 readily available.
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).
This medicinal product contains benzyl alcohol. Benzyl alcohol may cause

4.6 Fertility, pregnancy and lactation
No data are available on the use of this product in human pregnancy.
Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of
childbearing potential is intended, it is important to determine whether
or not she is pregnant. Any woman who has missed a period should
be assumed to be pregnant until proven otherwise. If in doubt about the
potential pregnancy (if the woman has missed a period, if the period is
very irregular, etc.), alternative techniques not using ionising radiation
(if there are any) should be offered to the patient.
Pregnancy
Radionuclide procedures carried out on pregnant women also involve
radiation dose to the foetus. Only essential investigations should therefore
be carried out during pregnancy, when the likely benefit far exceeds the
risk incurred by the mother and foetus.
Avoidance of pregnancy following administration of chromium-51 edetate
is not necessary for a woman of child-bearing potential because of the
low absorbed radiation dose associated with such an administration.
Breast-feeding
Before administering a radioactive medicinal product to a mother
who is breast-feeding, consideration should be given to the possibility
of delaying the administration of radionuclide until the mother has
ceased breast-feeding, and to what is the most appropriate choice
of radiopharmaceuticals, bearing in mind the secretion of activity in
breast milk. If the administration of chromium-51 edetate is considered
necessary, breast-feeding should be interrupted for 4 hours and the
expressed feeds discarded, after which time the level of activity in the
milk will not result in a radiation dose to the child greater than 1mSv.
Fertility
Animal reproduction studies have not been performed.
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:
Hypersensitivity
Not known:
Nervous system disorders:
Syncope vasovagal
Not known:
Unwanted effects have been reported infrequently after single or
repeated intravenous administrations of chromium-51 edetate such
that the incidence of individual reactions cannot be quantified. Limited
details are available, but mild allergic phenomena have been described.
The causation of the adverse events reported to date has not been firmly
established.
Exposure to ionising radiation is linked with cancer induction and a
potential for development of hereditary defects. As the effective dose
is 0.0231 mSv when the maximal recommended activity of 11MBq is
administered these adverse reactions are expected to occur with a low
probability.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via:
United Kingdom:
Yellow Card Scheme at www.mhra.gov.uk/yellowcard
Suomi/Finland:
www-sivusto: www.fimea.fi
Laakealan turvallisuus- ja kehittamiskeskus Fimea
Laakkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA
Ελλάδα/ Greece:
Εθνικός Οργανισμός Φαρμάκων
Μεσογείων 284
GR-15562 Χολαργός, Αθήνα
Τηλ: + 30 21 32040380/337
Φαξ: + 30 21 06549585
Ιστότοπος: http://www.eof.gr
Netherlands:
Nederlands Bijwerkingen Centrum Lareb.
Website: www.lareb.nl
4.9 Overdose
In the event of administration of a radiation overdose of chromium-51
edetate, the absorbed dose to the patient should be reduced where
possibly by increasing the elimination of the radionuclide from the body
by frequent emptying of the urinary bladder by hydration, diuretics and
catheterisation. It might be helpful to estimate the effective dose that was
applied.
5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, renal
system, chromium (51Cr) edetate, ATC code: V09CXO4
Chromium-51 edetate is a chemically stable, hydrophilic metal chelate. It
is metabolically inert.
Pharmacodynamic effects
Renal function is unaffected even by large amounts of chromium edetate.
At the chemical concentrations and activities used chromium-51 edetate
does not appear to exert any pharmacodynamic effects.
Clinical efficacy and safety
See Pharmacodynamic effects.
5.2 Pharmacokinetic properties
Distribution
Less than 0.5% plasma protein binding occurs.
Elimination
Following intravenous administration, the chromium-51 edetate
complex is excreted almost exclusively by the kidneys via the glomerular
membrane (less than 1% faecal excretion in 24 hours reported for an
anuric patient).

After intravenous administration, the chromium-51 edetate equilibrates
within the intra- and extravascular spaces, a process taking between
30 and 90 minutes. Beyond this period a constant percentage of the
chromium-51 edetate present in the extracellular fluid is excreted by the
kidneys per unit time.
In patients with normal or near-normal glomerular filtration rate the
recovery of unchanged chelate in the urine during the first 24 hours after
administration is close to 100% of the injected activity, cumulative faecal
clearance accounting for less than 0.1%. There is no significant tubular
secretion or re-absorption of chromium-51 edetate. However, a small
amount of tubular re-absorption, some whole body retention or complex
dissociation have each been postulated to explain the known but small
underestimation of inulin clearance by chromium-51 edetate.
Half-life
Total body retention is described by a double exponential function.
The mean value of the glomerular filtration rate in the normal adult is
approximately 130 ml/min in men and 120 ml/min in women (normalised
for body surface area of 1.73 m2).
Renal/Hepatic impairment
The pharmacokinetics in patients with renal or hepatic impairment has
not been characterised.
5.3 Preclinical safety data
It has been reported that no toxic effects were noted in dogs following
intravenous infusion for a period of 36 hours of 1.5 g chromium-51
edetate/kg.
Intravenous administration of a formulation of chromium-51 edetate to
rats and mice has indicated that the average lethal dose is more than
1000 times the maximum recommended dose to humans. Repeat dose
studies with the same formulation revealed no detrimental clinical or
histological effects when the equivalent of more than 50 times the
maximum recommended human dose was administered to rats and
dogs over a two week period. Chromium-51 edetate is not intended for
regular or continuous administration.
Mutagenicity studies and long-term carcinogenicity studies have not
been carried out.
6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Disodium EDTA Ph.Eur.
Benzyl alcohol Ph.Eur.
Water for injections Ph.Eur.
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 shelf-life of the product is not more than 90 days after the date of
release.
The reference date of the product is 60 days before expiry.
6.4 Special precautions for storage
Store below 25oC. Do not freeze.
Storage of radiopharmaceuticals should be in accordance with national
regulation on radioactive materials.
6.5 Nature and contents of container
The product is supplied in a 10ml Type I Ph.Eur clear, colourless, borosilicate
glass vial sealed with a PTFE faced rubber closure and oversealed with
an aluminium overseal with an aperture. Each vial is packed within a
radiation shielding container of lead metal.
Pack size: 37 MBq (10 ml vial).
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 organization.
Radiopharmaceuticals should be prepared in a manner which satisfies
both radiation safety and pharmaceutical quality requirements.
Appropriate aseptic precautions should be taken.
If at any time in the preparation of this product the integrity of this
container is compromised it should not be used.
Administration procedures should be carried out in a way to minimize
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.
Any unused medicinal product or waste material should be 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 00221/0108
Finland: 11192
Greece: 20616//17-03-2009
Netherlands: RVG 57761
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 05 July 1999
Date of last renewal: 28 May 2005
10 DATE OF REVISION OF THE TEXT
December 2016
11 DOSIMETRY
The table below shows 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).
Absorbed dose per unit activity administered
(mGy/MBq)
Organ

Adult

15 year

10 year

5 year

1 year

Adrenals

7.2E-04

9.2E-04

1.4E-03

2.1E-03

3.9E-03

Bladder
wall

2.4E-02

3.1E-02

3.8E-02

3.6E-02

6.6E-02

Bone
surfaces

8.2E-04

1.0E-03

1.4E-03

2.1E-03

3.8E-03

Brain

4.7E-04

6.0E-04

9.9E-04

1.6E-03

2.9E-03

Breast

4.3E-04

5.6E-04

8.3E-04

1.3E-03

2.5E-03

Gall
bladder

7.8E-04

1.0E-03

1.6E-03

2.2E-03

3.4E-03

Stomach

6.9E-04

8.5E-04

1.3E-03

2.0E-03

3.5E-03

SI

1.1E-03

1.4E-03

2.0E-03

2.7E-03

4.8E-03

Colon

1.3E-03

1.6E-03

2.2E-03

2.9E-03

4.9E-03

GI-tract

Absorbed dose per unit activity administered
(mGy/MBq)
Organ
(ULI

Adult

15 year

10 year

5 year

1 year

9.6E-04

1.2E-03

1.8E-03

2.6E-03

4.3E-03)

(LLI

1.7E-03

2.1E-03

2.8E-03

3.3E-03

5.6E-03)

Heart

6.3E-04

8.2E-04

1.3E-03

1.9E-03

3.4E-03

Kidneys

1.8E-03

2.2E-03

3.0E-03

4.4E-03

7.8E-03

Liver

6.5E-04

8.4E-04

1.3E-03

2.0E-03

3.6E-03

Lungs

5.5E-04

7.3E-04

1.1E-03

1.7E-03

3.1E-03

Muscles

7.7E-04

9.6E-04

1.4E-03

1.9E-03

3.6E-03

Oesophagus

5.7E-04

7.4E-04

1.1E-03

1.7E-03

3.2E-03

Ovaries

1.6E-03

2.0E-03

2.7E-03

3.3E-03

5.8E-03

Pancreas

7.5E-04

9.5E-04

1.5E-03

2.2E-03

4.0E-03

Red
marrow

7.4E-04

9.3E-04

1.3E-03

1.8E-03

3.2E-03

Skin

4.7E-04

5.8E-04

8.9E-04

1.4E-03

2.6E-03

Spleen

6.7E-04

8.7E-04

1.3E-03

2.0E-03

3.7E-03

Testes

1.2E-03

1.6E-03

2.5E-03

3.0E-03

5.4E-03

Thymus

5.7E-04

7.4E-04

1.1E-03

1.7E-03

3.2E-03

Thyroid

5.6E-04

7.4E-04

1.2E-03

1.9E-03

3.5E-03

Uterus

2.8E-03

3.4E-03

4.6E-03

5.1E-03

8.8E-03

Remaining
organs

7.7E-04

9.7E-04

1.4E-03

2.0E-03

3.6E-03

Effective
dose (mSv/
MBq)

2.0E-03

2.6E-03

3.4E-03

3.9E-03

7.1E-03

The data presented above assume a body retention half-time of
100 minutes and a renal transit time of 5 minutes. Data are also
presented for abnormal renal function in which the retention half-time is
1000 minutes and the renal transit time is increased to 20 minutes.
The table below shows the dosimetry as calculated according to the
Publication 53 of the ICRP (International Commission on Radiological
Protection, Radiation dose to Patients from Radiopharmaceuticals,
Pergamon Press 1987).
Abnormal renal function
Absorbed dose per unit activity administered
(mGy/MBq)
Organ

Adult

15 year

10 year

5 year

1 year

Adrenals

4.5E-03

5.0E-03

7.7E-03

1.2E-02

2.1E-02

Bladder
wall

2.1E-02

2.9E-02

4.2E-02

6.4E-02

1.2E-01

Bone
surfaces

3.6E-03

4.2E-03

6.4E-03

9.8E-03

1.8E-02

Breast

3.2E-03

3.2E-03

4.8E-03

7.6E-03

1.4E-02

Stomach
wall

4.1E-03

4.7E-03

7.2E-03

1.1E-02

1.9E-02

Small
intest

4.5E-03

5.5E-03

8.4E-03

1.3E-02

2.3E-02

GI-tract

ULI wall

4.3E-03

5.2E-03

7.7E-03

1.2E-02

2.1E-02

LLI wall

4.6E-03

5.7E-03

8.8E-03

1.3E-02

2.3E-02

Kidneys

8.3E-03

1.0E-02

1.4E-02

2.1E-02

3.6E-02

Liver

3.8E-03

4.6E-03

7.2E-03

1.1E-02

2.0E-02

Lungs

3.3E-03

4.2E-03

6.3E-03

9.7E-03

1.8E-02

Ovaries

4.6E-03

6.0E-03

9.1E-03

1.4E-02

2.5E-02

Pancreas

4.3E-03

5.2E-03

8.1E-03

1.2E-02

2.2E-02

Red
marrow

4.0E-03

4.8E-03

7.1E-03

1.0E-02

1.8E-02

Spleen

4.0E-03

4.8E-03

7.3E-03

1.1E-02

2.0E-02

Testes

3.7E-03

4.6E-03

7.2E-03

1.1E-02

2.1E-02

Thyroid

3.1E-03

4.3E-03

6.8E-03

1.1E-02

2.0E-02

Uterus

5.8E-03

7.1E-03

1.1E-02

1.7E-02

2.9E-02

Other
tissue

3.4E-03

4.1E-03

6.3E -03

9.9E-03

1.8E-02

Effective
dose
equivalent
(mSv/MBq)

5.2E-03

6.5E-03

9.7E-03

1.5E-02

2.7E-02

The effective dose resulting from the administration of a maximal
recommended activity of 11MBq for an adult weighing 70 kg is about
0.0231 mSv. For this product, the effective dose equivalent to a 70 kg
adult resulting from an administered activity of 1.1 to 6 MBq is typically
0.0025 to 0.014 mSv in the case of normal kidney function and is
0.0057 to 0.031 mSv under conditions of abnormal renal function.
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Solution for intravenous injection.
Withdrawals should be performed under aseptic conditions. The vials
must not be opened without 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.
13

OTHER INFORMATION

Manufacturer
GE Healthcare Limited
The Grove Centre
White Lion Road
Buckinghamshire HP7 9LL
United Kingdom
GE and the GE Monogram are the trademarks of General Electric
Company.

GE Healthcare

HEALTHCARE PROFESSIONAL
LEAFLET

Chromium (51Cr)
EDTA

3.7 MBq/ml solution
for injection
Chromium-51 edetate
CJ13P

9999999

L/5871/04

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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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