Striascan

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

Striascan 74 MBq/mL solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each mL of solution contains 74 MBq of ioflupane (123I) 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. 

 

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. 

 

Excipient 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. 

Striascan 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. 

Striascan 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. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s 

disease dementia. 

 

4.2 Posology and method of administration 

 

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

movement disorders and/or dementia.  

 

This medical product is for use in hospitals or in designated nuclear medicine facilities only. 

 



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Posology 

Clinical efficacy has been demonstrated across the range 110 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 Striascan.  

 

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).  

Careful consideration of the activity to be administered is required since an increased radiation exposure 

is possible in these patients. 

 

Paediatric population 

The safety and efficacy of Striascan in children and adolescents aged 0 to 18 years has not been 

established. No data are available. 

 

Method of administration  

Striascan is for intravenous use. 

 

For patient preparation, see section 4.4. 

 

Precautions to be taken before handling or administering the medicinal product  

Striascan 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. 

 

Image acquisition 

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 11-15 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 500 k 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 

 

Potential for hypersensitivity or anaphylactic reactions 

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

discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in 

emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator 

must be immediately available. 

 

Individual benefit/risk justification 

For each patient, 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. 



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Renal impairment / Hepatic impairment 

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

absence of data, Striascan is not recommended in cases of moderate to severe 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 radiation. 

 

Specific warnings 

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. 

 

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say 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 in humans. 

Ioflupane binds to the dopamine transporter. Active substances that bind to the dopamine transporter with 

high affinity may therefore interfere with Striascan diagnosis. These include: 

- amfetamine, 
- benzatropine,  
- bupropion,  
- cocaine,  
- mazindol,  
- methylphenidate,  
- phentermine and  
- sertraline. 

 

Active substances shown during clinical trials not to interfere with Striascan 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 Striascan imaging and can therefore be continued if desired. Medicinal products shown in 

animal studies not to interfere with Striascan imaging include pergolide. 

 

4.6 Fertility, pregnancy and lactation 

 

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.  



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If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very 

irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to 

the patient. 

 

Pregnancy 

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

Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. 

Administration of 185 MBq of ioflupane (123I) results in an absorbed dose to the uterus of 2.6 mGy. 

Striascan is contraindicated in pregnancy (see section 4.3). 

 

Breastfeeding 

It is not known whether ioflupane (123I) is excreted in human milk. Before administering 

radiopharmaceuticals 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 breastfeeding, and to what is 

the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity 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 

 

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

 

4.8 Undesirable effects 

 

The following undesirable effects are recognised for ioflupane (123I). 

 

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) 

Not known  (cannot be estimated from the available data) 

 



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

 

MedDRA Body system  

SOCs 

Adverse reaction 

Preferred term 

Frequency 

Immune system disorders 

 

Hypersensitivity Not known 

Metabolism and nutrition 

disorders 

 

Appetite increased Uncommon 

Nervous system disorders 

 

Headache Common 

Dizziness, formication 

(paraesthesia), dysgeusia 

Uncommon 

Ear and labyrinth disorders 

 

Vertigo Uncommon 

Vascular disorders 

 

Blood pressure decreased 

 

Not known 

Respiratory, thoracic and 

mediastinal disorders  

 

Dyspnea Not known 

Gastrointestinal disorders 

 

Nausea, dry mouth 

 

Uncommon 

 

Vomiting Not known 

Skin and subcutaneous tissue 

disorders 

 

Erythema, pruritus, rash, 

urticaria, hyperhidrosis 

Not known 

General disorders and 

administration site conditions 

Injection site pain (intense pain 

or burning sensation following 

administration into small veins) 

Uncommon 

Feeling hot Not known  

 

 

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

hereditary defects. As the effective dose is 4.6 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. 

 

4.9 Overdose 

 

In the event of administration of a radiation overdose, 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. 

 

At the chemical concentrations used for diagnostic examinations, Striascan does not appear to have any 

pharmacodynamic activity. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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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 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 ioflupane (123I) 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 ioflupane (123I) 

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 ioflupane (123I) 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%. 

 

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. 

 

Environmental Risk Assessment (ERA) 

 

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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6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Acetic acid, glacial (E 260) 

Sodium acetate, trihydrate (E 262) 

Ethanol, anhydrous (E 1510) 

Phosphoric acid, concentrated (E 338) 

Water for injections 

 

6.2 Incompatibilities 

 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products.  

 

6.3 Shelf life 

 

2.5 mL vial 

35 hours from the end of synthesis (7 hours from the activity reference time stated on the label) 

 

5 mL vial 

48 hours from the end of synthesis (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. 

Store in the original lead shielding. 

 

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive 

materials. 

 

6.5 Nature and contents of container 

 

15 mL amber glass vial sealed with a rubber closure and metal overseal. 

The vial is placed into a lead container for protective shielding and packed in a metal box. 

 

Pack size: 1 vial containing 2.5 mL or 5 mL of solution.  

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 

 

General warning 

Radiopharmaceuticals should be received, used and administered only by authorised persons in 

designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations 

and/or appropriate licences of the competent official organisation.  

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and 

pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. 

If at any time in the preparation of this product the integrity of this vial is compromised it should not be 

used. 

 

Administration procedures should be carried out in a way to minimise risk of contamination of the 

medicinal product and irradiation of the operators. Adequate shielding is mandatory. 

 



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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 

 

CIS bio international 

RN 306 – Saclay 

B.P. 32 

F-91192 Gif-sur-Yvette Cedex 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1372/001 (2.5 mL) 

EU/1/19/1372/002 (5 mL) 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

 

11. DOSIMETRY 

 

The biokinetic model for ioflupane (123I) adopted by ICRP 128 ((International Commission on 

Radiological Protection ,2015) assumes initial uptake of 31% of the administered activity in the liver, 

11% in the lungs, and 4% in the brain. The rest is assumed to be distributed uniformly in the remaining 

organs and tissues. For all organs and tissues, 80% is assumed to be excreted with a biological half-time 

of 58 h, and 20% with a half-time of 1.6 h. It is further assumed that 60% of the injected activity is 

excreted to the urine, and 40% is excreted to the gastrointestinal tract for all organs and tissues. Activity 

in the liver is excreted according to the Publication 53 gallbladder model (ICRP, 1987), where 30% is 

eliminated via the gallbladder and the remainder passes directly into the small intestine.  



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

ioflupane (123I) are listed below according to ICRP 128.  

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) 

 

Organ  Absorbed radiation dose 

µGy/MBq 

Adrenals 17 

Bone surfaces 15 

Brain 16 

Breasts 7.3 

Gallbladder wall 44 

Gastrointestinal tract  

Stomach wall 12 

Small intestine wall 26 

Colon wall 59 

(Upper large intestine wall ) 57 

(Lower large intestine wall) 62 

Heart wall 32 

Kidneys 13 

Liver 85 

Lungs 42 

Muscle 8.9 

Oesophagus 9.4 

Ovaries 18.0 

Pancreas 17.0 

Red marrow 9.3 

Salivary glands 41.0 

Skin 5.2 

Spleen 26.0 

Testes 6.3 

Thymus 9.4 

Thyroid 6.7 

Urinary bladder wall 35.0 

Uterus 14.0 

Remaining organs 10.0 

Effective Dose 25.0 µSv/MBq 

 

The effective dose (E) resulting from administration of 185 MBq of Striascan injection is 4.6 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. 

For an administered activity of 185 MBq the typical radiation dose to the target organ (brain) is 3 mGy 

and the typical radiation doses to the critical organs: liver and colon wall are 16 mGy and 11 mGy, 

respectively. 

 

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 

 

Not relevant. 

 

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

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

 

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


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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(s) responsible for batch release 

CIS BIO International 

Route Nationale 306 

Saclay BP 32 

91192 Gif-Sur-Yvette 

France 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING 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 

 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of an 

important (pharmacovigilance or risk minimisation) milestone being reached.  

 



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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Metal Box / Lead Pot - 5 mL presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Striascan 74 MBq /mL solution for injection. 

ioflupane (123I) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Ioflupane (123I): 74 MBq/mL at reference time  

 

 

3. LIST OF EXCIPIENTS 

 

E 1510 (see leaflet for further information), E 260, E 262, E 338, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

1 vial 

 

Volume: 5 mL 

370 MBq / vial  DD/MM/YYYY  xx h xx CET  

74 MBq / mL  DD/MM/YYYY xx h xx CET 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravenous use. 

 

 

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

THE SIGHT AND REACH OF CHILDREN 

 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Radioactive medicine. 

Symbol of radioactivity 

 

 

8. EXPIRY DATE 

 

EXP:    DD/MM/YYYY  xx h xx CET 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25°C. 

Do not freeze. Store in the original lead shielding. 

 

 

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 

 

Marketing authorisation holder and manufacturer: 

CIS bio international  

BP 32 

F-91192 GIF-SUR-YVETTE CEDEX 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

5 mL   EU/1/19/1372/002 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON 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. 

 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

Vial – 5 mL presentation 

 

 

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

 

Striascan 74 MBq/mL solution for injection. 

ioflupane (123I) 

 

I.V. 

 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP:    20 h post-ref. 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

Volume: 5 mL 

370 MBq / vial  at ref. (see outer label) 

74 MBq / mL  

 

 

6. OTHER 

 

Symbol of radioactivity 

 

Manufacturer name address 

CIS bio international  

F-91192 GIF-SUR-YVETTE CEDEX 

 

 

 

 

 

 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Metal Box / Lead Pot – 2.5 mL presentation 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Striascan 74 MBq /mL solution for injection. 

ioflupane (123I) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Ioflupane (123I): 74 MBq/mL at reference time  

 

 

3. LIST OF EXCIPIENTS 

 

E 1510 (see leaflet for further information), E 260, E 262, E 338, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

1 vial 

 

Volume: 2.5 mL 

185 MBq / vial  DD/MM/YYYY  xx h xx CET  

74 MBq / mL  DD/MM/YYYY  xx h xx CET 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravenous use. 

 

 

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

THE SIGHT AND REACH OF CHILDREN 

 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Radioactive medicine. 

Symbol of radioactivity 

 

 

8. EXPIRY DATE 

 

EXP:    DD/MM/YYYY  xx h xx CET 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25°C. 

Do not freeze. Store in the original lead shielding. 

 

 

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 

 

Marketing authorisation holder and manufacturer: 

CIS bio international  

BP 32 

F-91192 GIF-SUR-YVETTE CEDEX 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

2.5 mL  EU/1/19/1372/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON 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. 

 



20 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

Vial – 2.5 mL presentation 

 

 

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

 

Striascan 74 MBq/mL solution for injection. 

ioflupane (123I) 

 

I.V. 

 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP:    7 h post-ref. 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

Volume: 2.5 mL 

185 MBq / vial  at ref. (see outer label) 

74 MBq / mL  

 

 

6. OTHER 

 

Symbol of radioactivity 

 

Manufacturer name address 

CIS bio international  

F-91192 GIF-SUR-YVETTE CEDEX 

 



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B. PACKAGE LEAFLET 



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Package leaflet: Information for the patient 

 

Striascan 74 MBq/mL solution for injection 

ioflupane (123I) 

 

 

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 possible side 
effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Striascan is and what it is used for  

2. What you need to know before Striascan is used 

3. How Striascan is used 

4. Possible side effects  

5. How Striascan is stored  

6. Contents of the pack and other information 

 

 

1. What Striascan is and what it is used for 

 

This medicine is a radiopharmaceutical product for diagnostic use only.  

 

Striascan 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. 

 

Striascan is used only to identify illness. When this medicine is injected into a patient, it is carried around 

the body in the blood and 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 Striascan 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. 

 

 



23 

2. What you need to know before Striascan is used 

 

Striascan 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 this medicine if you have moderate or severe 

problems with your kidneys or liver. 

 

Before administration of Striascan 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 

Striascan is not recommended for children and adolescents aged 0 to 18 years. 

 

Other medicines and Striascan 

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 this medicine works. 

These include: 

 

• bupropion (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 Striascan. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 

nuclear medicine doctor for advice before you are given this medicine. 

 

You must inform the nuclear medicine doctor before the administration of Striascan if there is a 

possibility you might be pregnant, if you have missed your period or if you are breast-feeding.  

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure. 

 

If you are pregnant, do not use Striascan. This is because the child may receive some of the 

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

 

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

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

• You should not breast-feed your child for 3 days after this product 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 

It is considered unlikely that Striascan will affect your ability to drive or to use machines. 



24 

 

Striascan 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. 

 

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. 

 

 

3. How Striascan is used 

 

There are strict laws on the use, handling and disposal of radioactivity. Striascan 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. 

The nuclear medicine doctor supervising the procedure will decide on the quantity of Striascan to be used 

in your case. It will be the smallest quantity necessary to get the desired information.  

The quantity to be administered usually recommended for an adult ranges from 110 to 185 MBq 

(megabecquerel or MBq, the unit used to measure radioactivity). 

 

Administration of Striascan and conduct of the procedure 

Before you receive Striascan, 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. 

 

Striascan is given to you as an injection, usually into a vein in your arm. A single injection is enough.  

 

Duration of the procedure  

The camera pictures are usually taken 3 to 6 hours after the injection of this product. Your nuclear 

medicine doctor will inform you about the usual duration of the procedure. 

 

After administration of Striascan, you should urinate frequently in order to eliminate the product from 

your body.  

 

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving 

this medicine. Contact your nuclear medicine doctor if you have any questions. 

 

If you are given more Striascan than you should 

Since this product 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 Striascan. 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, this medicine 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 
 



25 

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 this product 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. 
 

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of 

cancer and hereditary abnormalities.  

 

Reporting of side effects 

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the 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 Striascan 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: 

• Do not store above 25°C. 

• Do not freeze. 
 

Do not use this medicine after the expiry date which is stated on the labels after EXP. 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 Striascan contains  

- The active substance is ioflupane (123I).  
Each mL of solution contains 74 MBq of ioflupane (123I) at reference time. 

 

- The other ingredients are acetic acid, glacial (E 260); sodium acetate trihydrate (E 262), ethanol, 
anhydrous (E 1510); phosphoric acid, concentrated (E 338) and water for injections. 

Please refer to section 2 “Striascan contains ethanol.” 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


26 

 

What Striascan looks like and contents of the pack 

Striascan is a colourless solution for injection, supplied in a single amber 15 mL glass vial sealed with a 

rubber closure and metal overseal. 

 

Pack size: 1 vial containing 2.5 mL or 5 mL. 

 

Marketing Authorisation Holder and Manufacturer 

 

CIS bio international 

RN 306 – Saclay 

B.P. 32 

F-91192 Gif-sur-Yvette Cedex 

FRANCE 

 

 

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. 

 

------------------------------------------------------------------------------------------------------------------------ 

 

The following information is intended for healthcare professionals only: 

 

The complete Summary of Product Characteristics (SmPC) of Striascan is provided as a separate 

document in the product packaging, with the objective to provide healthcare professionals with other 

additional scientific and practical information about the administration and use of this 

radiopharmaceutical. 

Please refer to the SmPc. 

 

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	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
	A. LABELLING
	B. PACKAGE LEAFLET