Celsunax · 4.1 Therapeutic indications · 1

HOS-099215 · has-adverse-reaction-information · PDF-Seite 6

The following undesirable effects are recognised for ioflupane (123I): 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. MedDRA system organ Adverse reaction Frequency classification (SOC) 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 4.63 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099211 · 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). 3

HOS-099210 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. Celsunax 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. Celsunax 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. Celsunax is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

HOS-099213 · has-interaction-information · PDF-Seite 4

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 Celsunax diagnosis. These include: - amfetamine, - bupropion, - cocaine, - codeine, - dexamfetamine, - methylphenidate, - modafinil, - phentermine, - Selective serotonin reuptake inhibitors, such as sertraline, may increase or decrease ioflupane binding to the dopamine transporter. 4 Active substances shown during clinical studies not to interfere with Celsunax imaging include: - amantadine, - trihexyphenidyl, - budipine, - levodopa, - metoprolol, - primidone, - propranolol, - selegiline. Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with Celsunax imaging and can therefore be continued if desired. Medicinal products shown in animal studies not to interfere with Celsunax imaging include pergolide.

HOS-099214 · has-pregnancy-information · PDF-Seite 5

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 to be 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. Celsunax is contraindicated in pregnancy (see section 4.3). Breast-feeding 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.

HOS-099212 · has-warning-information · PDF-Seite 4

Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. The necessary resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available, to enable immediate action in emergencies. 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. Individual benefit/risk justification 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. Renal impairment/hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, Celsunax 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 reduce radiation exposure. Specific warnings This medicinal product contains up to 197 mg of alcohol (ethanol) in each dose which is equivalent to 39.5 mg/mL (5% by volume). The amount in 5 mL of this medicinal product is equivalent to 5 mL beer or 2 mL wine. The small amount of alcohol in this medicinal product will not have any noticeable effects. Precautions with respect to environmental hazard see section 6.6.