DaTSCAN

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 



 2 

1. NAME OF THE MEDICINAL PRODUCT 

DaTSCAN 74 MBq/ml solution for injection 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml of solution contains ioflupane (123I) 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 (123I) (specific activity range 2.5 to  

4.5 x 1014 Bq/mmol) at reference time. 

Each 5 ml single dose vial contains 370 MBq ioflupane (123I) (specific activity range 2.5 to  

4.5 x 1014 Bq/mmol) at reference time.   

 

Excipient(s) with known effect 

This medicinal product contains 39.5 g/l ethanol. 

For the 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. 

 



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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 population 

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 

159 keV 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 11-15cm). 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 listed in section 6.1. 

- Pregnancy (see section 4.6). 

 

4.4 Special warnings and precautions for use 

 

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

immediately and, if necessary, intravenous treatment initiated.  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. 

 



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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 5 ml 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 amfetamine, 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 woman 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 ionising 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 (123I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is 

contraindicated in pregnancy (see section 4.3). 

 

Breastfeeding 

It is not known whether ioflupane (123I) 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. 

 



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4.8 Undesirable effects 

 

The following undesirable effects are recognised for DaTSCAN: 

 

Tabulated summary of adverse reactions 

The frequencies of adverse reactions 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).  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 

 

Skin and subcutaneous tissue disorders 

Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis 

 

Respiratory, thoracic and mediastinal disorders 

Not known: Dyspnea 

 

Gastrointestinal disorders 

Uncommon: Nausea, dry mouth 

Not known: Vomiting 

 

Vascular disorders 

Not known: Blood pressure decreased 

 

General disorders and administration site conditions 

Uncommon: Injection site pain (intense pain or burning sensation following administration into small 

veins)  

Not known: Feeling hot 

 

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

hereditary defects.  As the effective dose is 4.63 mSv when the maximal recommended activity of  

185 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 national reporting system 

listed in Appendix V. 

 



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4.9 Overdose 

 

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

order to minimise radiation dose 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: V09AB03. 

 

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

intravenous administration of DaTSCAN at the recommended dosage. 

 

Mechanism of action 

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 (123I) 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 efficacy 

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 

 

Distribution 

Ioflupane (123I) is cleared rapidly from the blood after intravenous injection; only 5% of the 

administered activity remains in whole blood at 5 minutes post-injection.  

 

Organ uptake 

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.  

 

Elimination 

At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with 

faecal excretion calculated at approximately 14%. 



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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 25oC. 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  

 

General warning 

Normal safety precautions for handling radioactive materials should be observed.  

 

Disposal 

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. 

 

 



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7. MARKETING AUTHORISATION HOLDER 

 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven  

The Netherlands 

 

 

8. MARKETING AUTHORISATION NUMBERS 

 

EU/1/00/135/001 (2.5 ml) 

EU/1/00/135/002 (5 ml) 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 27 July 2000 

Date of latest renewal:  28 July 2010 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

11 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 (123I) are listed in the Table 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.  



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 Target Organ 
Absorbed radiation dose 

Gy/MBq 

Adrenals 

Bone surface 

Brain 

Breast 

Gallbladder wall 

Gastrointestinal tract 

      Stomach wall 

      Small intestine wall 

      Colon wall 

      (Upper large intestine wall 

      (Lower large intestine wall 

Heart wall 

Kidneys 

Liver 

Lungs 

Muscles 

Oesophagus 

Ovaries 

Pancreas 

Red marrow 

Salivary glands 

Skin 

Spleen 

Testes 

Thymus 

Thyroid 

Urinary bladder wall 

Uterus 

Remaining organs 

17.0 

15.0 

16.0  

 7.3  

 44.0 

 

 12.0 

  26.0 

  59.0 

   57.0) 

   62.0) 

  32.0 

  13.0 

  85.0 

  42.0 

   8.9 

   9.4 

 18.0 

 17.0 

   9.3 

 41.0 

  5.2 

 26.0 

  6.3 

  9.4 

  6.7 

 35.0 

 14.0 

 10.0 

Effective Dose (µSv/MBq)  25.0  

Ref.: Publication 128 of the Annals of ICRP (Radiation dose to Patients from Radiopharmaceuticals: A Compendium  

of Current Information Related to Frequently Used Substances, 2015 
 

The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.63 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.  

 

 

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. See also section 6.6. 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

 

 

 

 

 

 

 



 10 

 

 

 

 

 

 

 
 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  
 

Name and address of the manufacturer responsible for batch release 

 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven 

The Netherlands 

 

 

B.  CONDITIONS OR RESTRICTIONS REARDING SUPPLY AND USE  

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic Safety Update Reports 

 

The requirements for submission of periodic safety update reports for this medicinal product are set out 

in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 

 

Not applicable



 12 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 



 13 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



 14 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

5 ml presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

DaTSCAN 74 MBq/ml solution for injection.  

Ioflupane (123I)  

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).  

 

3. LIST OF EXCIPIENTS 

 

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections. 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection  

1 vial 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 
 

 

8. EXPIRY DATE 

 

EXP: 20 h post-ref. 

Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25C. 

Do not freeze. 



 15 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Handling and disposal – see package leaflet. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven  

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/135/002  

 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

 

15.     INSTRUCTIONS FOR USE 

 

 

 

 

16.     INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted 

 

 

17.     UNIQUE IDENTIFIER – 2D BARCODE 

 

Not applicable 

 

 

18.     UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

Not applicable 

 

 

 

 



 16 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

5 ml presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

DaTSCAN 74 MBq/ml solution for injection. 

Ioflupane (123I)  

Intravenous use 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP: 20 h post-ref. 

Ref.: 370 MBq/5 ml ioflupane (123I) at 2300 CET on DD/MM/YYYY. 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

 

 

6. OTHER  

 

 
 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven 

The Netherlands 

 

 

 



 17 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

2.5 ml presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

DaTSCAN 74 MBq/ml solution for injection 

Ioflupane (123I)  

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).  

 

 

3. LIST OF EXCIPIENTS 

 

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

1 vial 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 
 

 

8. EXPIRY DATE 

 

EXP: 7 h post-ref. 

Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25C. 

Do not freeze. 



 18 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Handling and disposal – see package leaflet. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven  

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/135/001 

 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

 

15.     INSTRUCTIONS FOR USE 

 

 

 

 

16.     INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted 

 

 

17.     UNIQUE IDENTIFIER – 2D BARCODE 

 

Not applicable 

 

 

18.     UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

Not applicable 

 

 

 

 

 



 19 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

2.5 ml presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

DaTSCAN 74 MBq/ml solution for injection 

Ioflupane (123I)  

Intravenous use 

 

2. METHOD OF ADMINISTRATION 

 

 

 

 

3. EXPIRY DATE 

 

EXP: 7 h post-ref. 

Ref.: 185 MBq/2.5 ml ioflupane (123I) at 1200 CET on DD/MM/YYYY 

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

2.5 ml 

 

 

6. OTHER  

 

 
 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven 

The Netherlands 

 

 

 



 20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 



 21 

 

Package leaflet: Information for the user 

 

DaTSCAN 74 MBq/ml solution for injection 

Ioflupane (123I) 

 

 

Read all of this leaflet carefully before you start using 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 possible side 
effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What DaTSCAN is and what it is used for 
2. What you need to know before DaTSCAN is used 
3. How DaTSCAN is used 
4. Possible side effects 
5. How DaTSCAN is stored 
6. Contents of the pack and other information 
 

 

1. What DaTSCAN is and what it is used for  
 

DaTSCAN contains the active substance ioflupane (123I) which is used to help identify (diagnose) 

conditions in the brain. It belongs to a group of medicines called “radiopharmaceuticals”, which contain 

a small amount of radioactivity.  

• When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a 

short time.  

• Because it contains a small amount of radioactivity it can be detected from outside the body using 

special cameras.  

• A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is 

inside the organ and the body. This can give the doctor valuable information about how that organ 

is working. 

 

When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small 

area of your brain. Changes in this area of the brain occur in: 

• Parkinsonism (including Parkinson’s disease) and  

• dementia with Lewy bodies.  

 

A scan will give your doctor information about any changes in this area of your brain. Your doctor may 

feel that the scan would help in finding out more about your condition and deciding on possible 

treatment. 

 

When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than 

in some types of X-ray investigation. 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. 

 

This medicine is used for diagnostic use only. It is used only to identify illness. 



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2. What you need to know before DaTSCAN is used 

DaTSCAN must not be used  

• if you are allergic to ioflupane or any of the other ingredients of this medicine (listed in section 6). 

• if you are pregnant  

 

Warnings and precautions 

Talk to your nuclear medicine doctor before using DaTSCAN if you have a moderate or severe problem 

with your kidneys or liver.  

 

Children and adolescents  

DaTSCAN is not recommended for children aged 0 to 18 years  

 

Other medicines and DaTSCAN 

Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines.  

Some medicines or substances can affect the way that DaTSCAN works.  

These include: 

• buproprion (used to treat depression (sadness)) 

• benzatropine (used to treat Parkinson’s disease) 

• mazindol (reduces appetite, as a means to treat obesity)  

• sertraline (used to treat depression (sadness)) 

• methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness)) 

• phentermine (reduces appetite, as a means to treat obesity)  

• amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a 

drug of abuse) 

• cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse) 

 

Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking 

them for a short time before you receive DaTSCAN.  

 

Pregnancy and breast-feeding 

Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the 

child may receive some of the radioactivity. Tell your nuclear medicine doctor if you think you might be 

pregnant.  Alternative techniques which do not involve radioactivity should be considered. 

 

If you are breast-feeding, your nuclear medicine doctor may delay the use of DaTSCAN, or ask you to 

stop breast-feeding. It is not known whether ioflupane (123I) is passed into breast milk.  

• You should not breast-feed your child for 3 days after DaTSCAN is given.  

• Instead use formula feed for your child. Express your breast milk regularly and throw away any 

breast milk you have expressed.  

• You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.   

 

Driving and using machines 

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

 

DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is 

about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism and needs 

to be taken into account in pregnant or breastfeeding women, children and high risk groups such as 

patients with liver disease or epilepsy. Tell your doctor if any of these apply to you.  

3. How DaTSCAN is used 

There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN will always be used 

in a hospital or a similar place. It will only be handled and given to you by people who are trained and 

qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine. 



 23 

Your nuclear medicine doctor will decide the dose that is best for you.  

 

Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquid 

that contain iodine. These stop the radioactivity building-up in your thyroid gland. It is important that 

you take the tablets or liquid as the doctor tells you. 

 

DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended 

radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to 

measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours 

after the injection of DaTSCAN. 
 

If you are given more DaTSCAN than you should 

Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an 

overdose. Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get 

rid of the medicine. You will need to be careful with the water (urine) that you pass - your doctor will tell 

you what to do. This is normal practice with medicines like DaTSCAN. Any ioflupane (123I) which 

remains in your body will naturally lose its radioactivity. 

 

If you have any further questions on the use of this medicine, ask your nuclear medicine doctor who 

supervises the procedure.  

4. Possible side effects 

Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.  

The frequency of side effects is: 

 

Common:  may affect up to 1 in 10 people 

-  Headache 

 

Uncommon:  may affect up to 1 in 100 people 

-  Increased appetite 

-  Dizziness 

-  Taste disturbance 

-  Nausea 

-  Dry mouth 

-  Vertigo 

-  A brief irritating feeling similar to ants crawling over your skin (formication) 

-  Intense pain (or burning sensation) at the injection site. This has been reported among   

    patients receiving DaTSCAN into a small vein.  

 

Not known: frequency cannot be estimated from the available data. 

 -  Hypersensitivity (allergic) 

-  Shortness of breath   

-  Redness of the skin   

-  Itching   

-  Rash 

-  Hives (urticaria) 

-  Excessive sweating   

-  Vomiting 

-  Low blood pressure   

-  Feeling hot 

 

The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body 

in a few days without need for you to take special precautions.  

 



 24 

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 national reporting system listed 

in Appendix V.  By reporting side effects you can help provide more information on the safety of this 

medicine.  

 

 

5. How DaTSCAN 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.  

 

The following information is intended for the specialist only: 

 

• Keep this medicine out of the sight and reach of children. 

• Do not store above 25C.  

• Do not freeze. 

 

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The 

expiry date refers to the last day of that month.  Hospital staff will ensure that the product is stored and 

thrown away correctly and not used after the expiry date stated on the label.  

6. Contents of the pack and other information 

What DaTSCAN contains 

• The active substance is ioflupane (123I). Each ml of solution contains ioflupane (123I) 74 MBq at 

reference time (0.07 to 0.13 μg/ml of ioflupane).  

• The other ingredients are acetic acid, sodium acetate, ethanol and water for injections. 

 

What DaTSCAN looks like and contents of the pack 

DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass 

vial sealed with a rubber closure and metal overseal.   

Marketing Authorisation Holder and Manufacturer 

GE Healthcare B.V. 

De Rondom 8 

5612 AP, Eindhoven  

The Netherlands 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 
 

 

België/Belgique/Belgien  

GE Healthcare BVBA 

Tél/Tel: +32 (0) 2 719 7410 

 

Lietuva 

General Electric International Inc. 

Tel.: +370 68 726 753 

 

България 

GE Healthcare Bulgaria EOOD 

Teл: +359 2 9712561 

Luxembourg/Luxemburg  

GE Healthcare BVBA 

België/Belgique/Belgien 

Tél/Tel: +32 (0) 2 719 7410 

 



 25 

 

Česká republika 

M.G.P. spol. s r.o. 

Tel.: +420 577 212 140 

Magyarország 

Radizone Diagnost-X Kft. 

Tel: +36 1 787-5720 

 

Danmark 

GE Healthcare A/S 

Tlf: +45 70 2222 03 

Malta 

Pharma-Cos Ltd. 

Tel:  +356 21441 870 

 

Deutschland 

GE Healthcare Buchler GmbH & Co. KG 

Tel: +49 (0) 5 307 93 00 

Nederland 

GE Healthcare B.V. 

Tel: +31 (0) 40 299 10 00  

 

Eesti 

GE Healthcare Estonia OÜ 

Tel: +372 6260 061 

Norge 

GE Healthcare AS 

Tlf: +47 23 18 50 50 

 

 Ελλάδα 

GE Healthcare A.E. 

Τηλ: +30 210 8930600 

Österreich 

GE Healthcare Handels GmbH 

Tel: +43 (0) 1 97272-0 

 

España 

GE Healthcare Bio-Sciences, S.A.U 

Tel: +34 91 663 25 00 

Polska 

GE Medical Systems Polska Sp. z o.o. 

Tel: +4822 330 83 00 

 

France 

GE Healthcare SAS 

Tél: +33 1 34 49 54 54 

Portugal 

Satis – GE Healthcare 

Tel: +351 214251352 

 

Hrvatska 

GE Healthcare d.o.o. 

Tel: +385 (0)1 61 70 280 

România 

S.C. GENERAL ELECTRIC MEDICAL 

SYSTEMS ROMANIA S.R.L.  

Tel. +40 37 2074527 

 

Ireland 

GE Healthcare Limited 

UK 

Tel: +44 (0) 1494 54 40 00 

 

Slovenija 

Biomedis M.B. trgovina d.o.o. 

Tel: +386 2 4716300 

Ísland 

Icepharma 

Sími: + 354 540 8000 

Slovenská republika 

MGP, spol. s r. o. 

Tel: +421 2 5465 4841 

 

Italia 

GE Healthcare S.r.l. 

Tel: +39 02 26001 111 

Suomi/Finland 

Oy GE Healthcare Bio-Sciences Ab 

Puh/Tel: +358 10 39411 

 

Κύπρος 

Phadisco Ltd 

Τηλ: +357 22 715000 

Sverige 

GE Healthcare AB 

Tel: +46 (0) 8 559 504 00 

 

Latvija 

General Electric International Inc. 

Tel: +371 6780 7086 

United Kingdom 

GE Healthcare Limited 

Tel: +44(0)1494 544000 

 



 26 

 

This leaflet was last revised in <{MM/YYYY} 
 

Detailed information on this medicine is available on the European Medicines Agency web site; 

http://www.ema.europa.eu. 

 

This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET