Compulsory Statement

Ioflupane (¹²³I) Rotop 74 MBq/ml Solution for injection
Name of the medicinal product: Ioflupane (¹²³I) Rotop 74 MBq/ml Solution for injection. Composition: Each ml of solution contains ioflupane (¹²³I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane). Excipients: Acetic acid (for pH adjustment), sodium acetate (for pH adjustment), ethanol (anhydrous), water for injections. Indications: This medicinal product is for diagnostic use only. Ioflupane (¹²³I) Rotop is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum 1) 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. Ioflupane (¹²³I) Rotop is unable to discriminate between Parkinson‘s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy) and 2) in adult patients to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease (Ioflupane (¹²³I) Rotop is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia). Contraindications: Hypersensitivity to the active substance or to any of the excipients and pregnancy. Undesirable effects: Common (≥ 1/100 to <1/10): headache. Uncommon (≥ 1/1,000 to <1/100): appetite increased, dizziness, formication (paraesthesia), dysgeusia, vertigo, nausea, dry mouth, injection site pain (intense pain or burning sensation following administration into small veins). Not known (cannot be estimated from the available data): hypersensitivity, blood pressure decreased, dyspnea, vomiting, erythema, pruritus, rash, urticaria, hyperhidrosis, 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 reactions are expected to occur with a low probability. Marketing Authorization Holder: ROTOP Radiopharmacy GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany.

Healthcare professionals are asked to report any suspected adverse reactions to pharmacovigilance@rotop-pharmaka.com. Adverse events should be reported to ROTOP Pharmaka GmbH, Tel: +49 351 26 310 0.

Last revision of the text: May 2022

For further information, please contact the ROTOP Team under ioflupane@rotop-pharmaka.com or the local distributor.