Striascan · 4.3 Contraindications · 1

HOS-287361 · has-adverse-reaction-information · PDF-Seite 6

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) 6 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. MedDRA Body system Adverse reaction Frequency SOCs Preferred term Immune system disorders Hypersensitivity Not known Metabolism and nutrition Appetite increased Uncommon disorders Nervous system disorders Headache Common Dizziness, formication Uncommon (paraesthesia), dysgeusia Ear and labyrinth disorders Vertigo Uncommon Vascular disorders Blood pressure decreased Not known Respiratory, thoracic and Dyspnea Not known mediastinal disorders Gastrointestinal disorders Nausea, dry mouth Uncommon Vomiting Not known Skin and subcutaneous tissue Erythema, pruritus, rash, Not known disorders urticaria, hyperhidrosis General disorders and Injection site pain (intense pain Uncommon administration site conditions or burning sensation following administration into small veins) 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

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HOS-287357 · has-contraindication-information · PDF-Seite 3

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Pregnancy (see section 4.6).

HOS-287356 · has-indication-information · PDF-Seite 2

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 d i s e a s e . Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

HOS-287359 · has-interaction-information · PDF-Seite 5

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, - bupropion, - cocaine, - codeine, - dexamfetamine, - methylphenidate, - modafinil, - phentermine, Selective serotonin reuptake inhibitors (SSRIs), such as sertraline, may increase or decrease ioflupane binding to the dopamine transporter. Serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine, may decrease ioflupane binding to the dopamine transporter especially in patients on higher doses. 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.

HOS-287360 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about 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). 5 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.

HOS-287358 · has-warning-information · PDF-Seite 3

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. 3 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 and after the examination and urged to void as often as possible during the first 48 hours after the procedure in order to minimise radiation exposure. Interpretation of Striascan Images Striascan images are interpreted visually, based upon the appearance of the striata. Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determination of whether an image is normal or abnormal is made by assessing the extent (as indicated by shape) and intensity (in relation to the background) of the striatal signal. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal or reduced intensity and/or loss of crescent. As an adjunct, visual interpretation may be assisted by semi-quantitative assessment using CE-marked software, where Striascan uptake in the striatum is compared with uptake in a reference region and ratios are compared against an age adjusted healthy subjects’ database. The evaluation of ratios, such as the left/right striatum Striascan uptake (symmetry) or caudate/putamen uptake, may further help with the image assessment. The following precautions should be taken when using semi-quantitative methods: • Semi

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