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IOFLUPANE (123I) ROTOP is a brand name for Ioflupane. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. Ioflupane (123I) Rotop 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Prior to administration appropriate resuscitation equipment should be available. Ioflupane (123I) Rotop should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia.
Ioflupane (123I) Rotop should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting. 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 Ioflupane (123I) Rotop.
Special populations Renal and hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment. 4). Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Paediatric population The safety and efficacy of Ioflupane (123I) Rotop in children aged 0 to 18 years has not been established. No data are available. Method of administration For intravenous use. For patient preparation, see section
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) 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 Headache CommonNervous system disorders 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 Nausea, dry mouth UncommonGastrointestinal disorders Vomiting Not known Skin and subcutaneous tissue disorders Erythema, pruritus, rash, urticaria, hyperhidrosis Not known Injection site pain (intense pain or burning sensation following administration into small veins) UncommonGeneral disorders and administration site conditions Feeling hot Not known Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
63 mSv when the maximal recommended activity of 185 MBq is administered these adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4. Ioflupane (123I) Rotop 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). 5 mm for those systems currently in use. A minimum of 500 k counts should be collected for optimal images.
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. Renal impairment / Hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment.
In the absence of data, Ioflupane (123I) Rotop 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Ioflupane (123I) Rotop Images Ioflupane (123I) Rotop 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 Ioflupane (123I) Rotop 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 Ioflupane (123I) Rotop 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-quantification should only be used an adjunct to visual assessment • Only CE marked software should be used • Users should be trained in the use of CE marked software by the manufacturer and follow EANM practice guidelines for image acquisition, reconstruction and assessment • Readers should interpret the scan visually and then perform the semi-quantitative analysis according to manufacturer’s instructions including quality checks for the quantitation process • ROI /VOI techniques should be used to compare uptake in the striatum with uptake in a reference region • Comparison against an age adjusted healthy subjects database is recommended to account for age-expected decrease in striatal binding • The reconstruction and filter settings (including attenuation correction) used can affect the semi-quantitative values.
The reconstruction and filter settings recommended by the manufacturer of the CE marked software should be followed and should match those used for semi- quantification of the healthy subjects database. • The intensity of the striatal signal as measured by SBR (striatal binding ratio) and asymmetry and caudate to putamen ratio provide objective numerical values corresponding to the visual assessment parameters and can be helpful in difficult to read cases • If the semi-quantitative values are inconsistent with the visual interpretation, the scan should be evaluated for appropriate placement of the ROIs /VOIs, correct image orientation and appropriate parameters for image acquisition and attenuation correction should be verified.
6 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. 6.