DATSCAN 74 MBQML

Israel - English - Ministry of Health

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Active ingredient:
IOFLUPANE
Available from:
ELDAN ELECTRONIC INSTRUMENTS CO LTD
ATC code:
V09AB03
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
IOFLUPANE 74 MBQ/ML
Administration route:
I.V
Prescription type:
Required
Manufactured by:
GE HEALTHCARE B.V., THE NETHERLAND
Therapeutic group:
OTHER DOPAMINERGIC AGENTS
Therapeutic area:
IODINE IOFLUPANE (123I)
Therapeutic indications:
Datscan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: - In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease Multiple System Atrophy and Progressive Supranuclear Palsy. - Datscan is unable to discriminate between Parkinson's Disease Multiple System Atrophy and Progressive Supranuclear Palsy. - In adult patients to help differentiate probable dementia with Lewy bodies from Alzheimer's disease. Datscan is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia
Authorization number:
131 95 30983 00
Authorization date:
2014-11-30

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

:ךיראת

01.07.13

םש

רישכת

תילגנאב

רפסמו

:םושירה

DATSCAN 74 MBQ/ML

םש

לעב

םושירה

:

ELDAN ELECTRONIC INSTRUMENT

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

4.1

Therapeutic

indications

Therapoitic group; other dopaminergic agents

This medicinal product is for diagnostic use

only.

DaTSCAN is indicated for detecting loss of

functional dopaminergic neuron terminals in the

striatum:

In patients with clinically uncertain

Parkinsonian Syndromes, in order to help

differentiate Essential Tremor from

Parkinsonian Syndromes related to idiopathic

Parkinson’s Disease, Multiple System

Atrophy and Progressive Supranuclear Palsy.

DaTSCAN is unable to discriminate between

Parkinson's Disease, Multiple System

Atrophy and Progressive Supranuclear Palsy.

To help differentiate probable dementia with

Lewy bodies from Alzheimer's disease.

DaTSCAN is unable to discriminate between

dementia with Lewy bodies and Parkinson's

disease dementia.

This medicinal product is for

diagnostic use only.

DaTSCAN is indicated for detecting loss

of functional dopaminergic neuron

terminals in the striatum:

In adult patients with clinically

uncertain Parkinsonian

Syndromes, for example those

with early symptoms, in order to

help differentiate Essential

Tremor from Parkinsonian

Syndromes related to idiopathic

Parkinson’s Disease, Multiple

System Atrophy and Progressive

Supranuclear Palsy.

DaTSCAN is unable to

discriminate between Parkinson's

Disease, Multiple System Atrophy

and Progressive Supranuclear

Palsy.

In adult patients

,

to help

differentiate probable dementia

with Lewy bodies from

Alzheimer's disease.

DaTSCAN is unable to

discriminate between dementia

with Lewy bodies and Parkinson's

disease dementia.

4.2

Posology and

method of

administration

DaTSCAN should only be used in patients referred

by physicians experienced in the management of

movement disorders and/or dementia.

Radiopharmaceutical agents should only be used by

qualified personnel with the appropriate government

authorisation for the use and manipulation of

radionuclides within a designated clinical setting.

Prior to administration appropriate

resuscitation equipment should be

available.

DaTSCAN should only be used in adult

patients referred by physicians

experienced in the management of

movement disorders and/or dementia.

DaTSCAN should only be used by

qualified personnel with the appropriate

government authorisation for the use and

DaTSCAN

is a 5% (v/v) ethanolic solution for

intravenous injection and should be used without

dilution. Clinical efficacy has been demonstrated

across the range 111-185 MBq. Do not exceed

185 MBq and do not use when the activity is below

110 MBq. In the event of overdosage, refer to section

4.9.

To minimise the potential for pain at the injection site

during administration, a slow intravenous injection

(not less than 15 – 20 seconds) via an arm vein is

recommended.

Patients must undergo appropriate thyroid blocking

treatment prior to injection to minimise thyroid

uptake of radioactive iodine, for example by oral

administration of approximately 120 mg potassium

iodide 1-4 hours prior to injection and again 12-24

hours post-injection of DaTSCAN.

SPECT imaging should take place between three and

six hours post-injection. Images should be acquired

using a gamma camera fitted with a high-resolution

collimator and calibrated using the 159keV

photopeak and a ± 10% energy window. Angular

sampling should preferably be not less than 120

views over 360 degrees. For high resolution

collimators the radius of rotation should be consistent

and set as small as possible (typically 11-15 cm).

Experimental studies with a striatal phantom, suggest

that optimal images are obtained with matrix size and

zoom factors selected to give a pixel size of 3.5 – 4.5

mm for those systems currently in use. A minimum

of 500k counts should be collected for optimal

images. Normal images are characterised by two

symmetrical crescent-shaped areas of equal intensity.

Abnormal images are either asymmetric or

symmetric with unequal intensity and/or loss of

crescent.

DaTSCAN

is not recommended for use in children or

adolescents due to a lack of data on safety and

efficacy.

manipulation of radionuclides within a

designated clinical setting.

Posology

Clinical efficacy has been demonstrated

across the range 111to 185 MBq. Do not

exceed 185 MBq and do not use when the

activity is below 110 MBq

Patients must undergo appropriate thyroid

blocking treatment prior to injection to

minimise thyroid uptake of radioactive

iodine, for example by oral administration

of approximately 120 mg potassium

iodide 1 to 4 hours prior to injection of

DaTSCAN.

Special Populations

Renal and hepatic impairment

Formal studies have not been carried

out in patients with significant renal or

hepatic impairment. No data are

available (see section 4.4).

Paediatric populations

The safety and efficacy of

DaTSCAN

in

children aged 0 to 18 years has not been

established. No data are available.

Method of Administration

For intravenous use

.

DaTSCAN should be used without

dilution. To minimise the potential for

pain at the injection site during

administration, a slow intravenous

injection (not less than 15 to 20 secinds)

via an arm vein is recommended

.

SPECT imaging should take place

between three and six hours post-

injection. Images should be acquired

using a gamma camera fitted with a high-

resolution collimator and calibrated using

the 159keV photopeak and a ± 10%

energy window. Angular sampling should

preferably be not less than 120 views over

360 degrees. For high resolution

collimators the radius of rotation should

be consistent and set as small as possible

(typically 11-15 cm). Experimental

studies with a striatal phantom, suggest

that optimal images are obtained with

matrix size and zoom factors selected to

give a pixel size of 3.5 – 4.5 mm for

those systems currently in use. A

minimum of 500k counts should be

collected for optimal images. Normal

images are characterised by two

symmetrical crescent-shaped areas of

equal intensity. Abnormal images are

either asymmetric or symmetric with

unequal intensity and/or loss of crescent.

4.4

Special warnings

and special

precautions for

use

This radiopharmaceutical may 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 the appropriate licences of the local competent

official organisations.

Formal studies have not been carried out in patients

with significant renal or hepatic impairment. In the

absence of data, DaTSCAN is not recommended in

cases of moderate to severe renal or hepatic

impairment.

This medicinal product contains (5% volume) ethanol

(alcohol), up to 197 mg per dose, equivalent to 5ml

beer, 2 ml wine. Harmful for those suffering from

alcoholism. To be taken into account in high-risk

groups such as patients with liver disease or epilepsy.

If hypersensitivity reactions occur, the

administration of the medicinal product

must be discontinued immediately and,

if necessary, intravenous treatment

intiated. Resuscitative medicinal

products and equipment ( e.g

endotracheal tube and ventilator) have

to be readily available.

This radiopharmaceutical may 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 the appropriate licences of the local

competent official organisations.

For each patient, exposure to ionising

radiation must be justifiable on the

basis of likely benefit. The activity

administered must be such that the

resulting dose is as low as reasonably

achievable bearing in mind the need to

obtain the intended diagnostic result.

Formal studies have not been carried out

in patients with significant renal or

hepatic impairment. In the absence of

data, DaTSCAN is not recommended in

cases of moderate to severe renal or

hepatic impairment.

This medicinal product contains 39.5 g/l

(5% volume) ethanol (alcohol), up to 197

mg per dose, equivalent to 5ml beer or 2

ml wine. Harmful for those suffering from

alcoholism. To be taken into account in

high-risk groups such as patients with

liver disease or epilepsy.

4.8

Undesirable

effects

No serious adverse reactions related to DaTSCAN

administration have been reported. The following

common side effects are recognised for DaTSCAN:

Summary of the safety profile

No serious adverse reactions related to

DaTSCAN administration have been

reported.

Tabulated summary of adverse

Metabolism and nutrition disorders

Appetite increased

Nervous system disorders

Headache

formication (paraesthesia)

Ear and labyrinth disorders

Vertigo

The following uncommon side effects are recognized

for DaTSCAN:

General disorders and administration site conditions

Injection site pain (intense pain following

administration into small veins)

For each patient, exposure to ionising radiation must

be justifiable on the basis of likely benefit. The

activity administered must be such that the resulting

radiation dose is as low as reasonably achievable

bearing in mind the need to obtain the intended

diagnostic result. Exposure to ionising radiation is

linked with cancer induction and a potential for

development of hereditary defects.

For diagnostic nuclear medicine investigations, the

current evidence suggests that these adverse events

will occur with negligible frequency because of the

low radiation dose incurred.

reactions

The frequencies of adverse reactions

are defined as follows:

Very

common

(≥1/10),

common

(≥1/100,

<1/10),

uncommon (≥1/1,000, <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).

Within

each

frequency

grouping, undesirable effects

are

presented

in order of

decreasing seriousness.

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Uncommon: Appetite increased

Nervous system disorders

Common: Headache

Uncommon: Dizziness

,

formication

(paraesthesia), dysgeusia

Ear and labyrinth disorders

Uncommon

:

Vertigo

Gastrointestinal disorders

Uncommon: Nausea, dry mouth

General disorders and administration

site conditions

Uncommon: Injection site pain (intense

pain following administration into small

veins).

Exposure to ionising radiation is linked

with cancer induction and a potential for

development of hereditary defects. As the

effective dose is 4.35 mSv when the

maximal recommended activity of 185

MBq is administered these adverse

events are expected to occur with a low

probability.

5.3

Preclinical

safety data

Acute toxicity studies employing ioflupane at dosage

levels of 0.06 mg/kg, in excess of 6,500 times the

maximum human (70 kg) single dose on a

bodyweight basis, failed to reveal any mortality or

signs of systemic toxicity in rats or rabbits. In 14 day

repeat dose studies no evidence of toxicity was

observed in rats or rabbits following daily doses of

0.6 mg/kg ioflupane, more than 65,000 times the

maximum human (70 kg) single dose on a

bodyweight basis. Behavioural effects due to

pharmacological activity were observed in these

studies.

Studies on reproductive toxicity have not been

conducted. Ioflupane showed no evidence of

mutagenic potential in in vitro or in vivo

mutagenicity studies. Studies to assess the

carcinogenic potential of ioflupane have not been

performed.

Non-clinical data for ioflupane reveal

no special hazard for humas based on

conventional studies of safety

pharmacology, single and repeated dose

toxicity and genotoxicity.

Studies on reproductive toxicity and to

assess the carcinogenic potential of

ioflupane have not been performed.

DATSCAN

1.

NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution contains Ioflupane (

I) 74 MBq at reference time (0.07 to 0.13 μg/ml of

ioflupane).

Each 2.5 ml single dose vial contains 185 MBq ioflupane (

I) (specific activity range 2.5 to 4.5 x 10

Bq/mmol) at reference time.

Each 5 ml single dose vial contains 370 MBq ioflupane (

I) (specific activity range 2.5 to 4.5 x 10

Bq/mmol) at reference time.

Excipients:

This medicinal product contains 39.5 g/l ethanol.

For a full list of excipients see section 6.1

3.

PHARMACEUTICAL FORM

Solution for injection.

Clear colourless solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

This medicinal product is for diagnostic use only.

DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with

early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes

related to idiopathic Parkinson’s Disease, Multiple System Atrophy and Progressive

Supranuclear Palsy.

DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy

and Progressive Supranuclear Palsy.

In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's

disease.

DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson's

disease dementia.

4.2

Posology and method of administration

Prior to administration appropriate resuscitation equipment should be available.

DaTSCAN should only be used in adult patients referred by physicians experienced in the management

of movement disorders and/or dementia. DaTSCAN should only be used by qualified personnel with

the appropriate government authorisation for the use and manipulation of radionuclides within a

designated clinical setting.

Posology

Clinical efficacy has been demonstrated across the range 111 to 185 MBq. Do not exceed

185 MBq and do not use when the activity is below 110 MBq.

Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid

uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium

iodide 1 to 4 hours prior to injection of DaTSCAN.

Special Populations

Renal and hepatic impairment

Formal studies have not been carried out in patients with significant renal or hepatic impairment. No

data are available (see section 4.4).

Paediatric populations

The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established. No data

are available.

Method of Administration

For intravenous use.

DaTSCAN should be used without dilution. To minimise the potential for pain at the injection site

during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is

recommended.

SPECT imaging should take place between three and six hours post-injection. Images should be

acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the

159keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than

120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent

and set as small as possible (typically 11-15 cm). Experimental studies with a striatal phantom, suggest

that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5 –

4.5 mm for those systems currently in use. A minimum of 500k counts should be collected for optimal

images. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity.

Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.

4.3

Contraindications

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

-Pregnancy (see section 4.6).

4.4

Special warnings and special precautions for use

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued

immediately and, if necessary, intravenous treatment intiated. Resuscitative medicinal products and

equipment ( e.g endotracheal tube and ventilator) have to be readily available.

This radiopharmaceutical may 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 the appropriate licences of the local competent official organisations.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The

activity administered must be such that the resulting dose is as low as reasonably achievable bearing in

mind the need to obtain the intended diagnostic result.

Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the

absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic

impairment.

This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose,

equivalent to 5ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into

account in high-risk groups such as patients with liver disease or epilepsy.

4.5

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed in humans.

Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high

affinity may therefore interfere with DaTSCAN diagnosis. These include amphetamine, benzatropine,

buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.

Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine,

trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine

agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere

with DaTSCAN imaging and can therefore be continued if desired.Medicinal Products shown in animal

studies not to interfere with DaTSCAN imaging include pergolide.

4.6

Fertility, pregnancy and lactation

Women of childbearing potential

Where it is necessary to administer radioactive medicinal products to women of childbearing potential,

information should always be sought about pregnancy.Any women who has missed a period should be

assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation

exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques

which do not involve inising radiation should be considered.

Pregnancy

Animal reproductive toxicity studies have not been performed with this product. Radionuclide

procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of

185 MBq of ioflupane (

I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is

contraindicated in pregnancy (see section 4.3).

Bresstfeeding

It is not known whether ioflupane (

I) is excreted in human milk. Before administering a radioactive

medicinal product to a breast-feeding mother, 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, bearing in mind the secretion of

radioactivity in breast milk. If administration is considered necessary, breast-feeding should be

interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be

expressed at regular intervals and the expressed feeds should be discarded.

Fertility

No fertility studies have been performed. No data are available.

4.7

Effects on ability to drive and use machines

DaTSCAN has no known influence on the ability to drive and use machines.

4.8

Undesirable effects

Summary of the safety profile

No serious adverse reactions related to DaTSCAN administration have been reported.

Tabulated summary of adverse reactions

The frequencies of adverse reactions are defined as follows:

Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <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). Within

each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Uncommon: Appetite increased

Nervous system disorders

Common: Headache

Uncommon: Dizziness, formication (paraesthesia), dysgeusia

Ear and labyrinth disorders

Uncommon: Vertigo

Gastrointestinal disorders

Uncommon: Nausea, dry mouth

General disorders and administration site conditions

Uncommon: Injection site pain (intense pain following administration into small veins)

Exposure to ionising radiation is linked with cancer induction and a potential for development of

hereditary defects. As the effective dose is 4.35 mSv when the maximal recommended activity of 185

MBq is administered these adverse events are expected to occur with a low probability.

4.9

Overdose

In cases of overdose of radioactivity, frequent micturition and defaecation should be encouraged in

order to minimise radiation dosage to the patient. Care should be taken to avoid contamination from the

radioactivity eliminated by the patient using such methods.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system, ATC code: V09A

B 03.

Due to the low quantities of ioflupane injected, pharmacological effects are not expected following

intravenous administration of DaTSCAN at the recommended dosage.

Ioflupane is a cocaine analogue. Studies in animals have shown that ioflupane binds with high affinity

to the presynaptic dopamine transporter and so radiolabelled ioflupane (

I) can be used as a surrogate

marker to examine the integrity of the dopaminergic nigrostriatal neurons. Ioflupane also binds to the

serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.

There is no experience in types of tremor other than essential tremor.

Clinical studies in patients with dementia with Lewy bodies

In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB)

(144 subjects), Alzheimer's disease (124 subjects), vascular dementia (9 subjects) or other (11

subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were

compared to the clinical diagnosis as determined by physicians experienced in the management and

diagnosis of dementias. Clinical categorisation into the respective dementia group was based on a

standardised and comprehensive clinical and neuropsychiatric evaluation. The values for the sensitivity

of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and

specificity from 88.6% to 91.4%. The positive predictive value ranged from 78.9% to 84.4% and the

negative predictive value from 86.1% to 88.7%. Analyses in which both possible and probable DLB

patients were compared with non-DLB dementia patients demonstrated values for the sensitivity of

DaTSCAN ranging from 75.0% to 80.2% and specificity from 81.3% to 83.9% when the possible DLB

patients were included as non-DLB patients. The sensitivity ranged from 60.6% to 63.4% and

specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.

5.2

Pharmacokinetic properties

Ioflupane (

I) is cleared rapidly from the blood after intravenous injection; only 5% of the

administered activity remains in whole blood at 5 minutes post-injection. Uptake in the brain is rapid,

reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours.

About 30% of the whole brain activity is attributed to striatal uptake. At 48 hours post-injection,

approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion

calculated at approximately 14%.

5.3

Preclinical safety data

Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of

safety pharmacology, single and repeated dose toxicity and genotoxicity.

Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been

performed.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Acetic acid

Sodium acetate

Ethanol

Water for injections

6.2

Incompatibilities

Not applicable.

6.3

Shelf-life

2.5 ml vial: 7 hours from the activity reference time stated on the label

5 ml vial: 20 hours from the activity reference time stated on the label

6.4

Special precautions for storage

Do not store above 25

C. Do not freeze.

6.5

Nature and contents of container

2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal

overseal.

Pack size of 1.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

Normal safety precautions for handling radioactive materials should be observed. 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

Little Chalfont

Bucks HP7 9NA

United Kingdom

8.

REGISTRATION HOLDER

Eldan Electronic Indtruments Co. Ltd.

6 Hashiloach st. P.O.B. 7641

Petach – Tiqva 49170

Israel

9.

DOSIMETRY

Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a

predominant energy of 159 keV and X-rays of 27 keV.

The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection

of ioflupane (

I) are listed below. The values are calculated assuming urinary bladder emptying at 4.8-

hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter).

Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.

Target Organ

Absorbed radiation dose

Gy/MBq

Adrenals

Brain

Breasts

Gallbladder wall

Lower large intestine wall

Small intestine

Stomach

Upper large intestine wall

Heart wall

Kidneys

Liver

Lungs

Muscle

Ovaries

Pancreas

Bone marrow

Bone surfaces

Skin

13.1

18.1

25.7

42.4

20.6

11.4

38.1

13.1

11.1

28.3

42.5

17.0

13.2

17.4

Spleen

Testes

Thymus

Thyroid

Urinary bladder wall

Uterus

Total body

10.6

10.3

53.5

16.3

11.5

Effective Dose

23.5

Sv/MBq

The effective dose (E) resulting from administration of a 185 MBq dose of DaTSCAN injection is 4.35

mSv (per 70 kg individual). The above data are valid in normal pharmacokinetic behaviour. When renal

or hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be

increased.

10.

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Any unused product or waste material should be disposed of in accordance with local requirements. See

also section 6.6.

The format of this leaflet was determined by the ministry of health (MOH) and its content was

chechked and approved by the MOH, December 201

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