MEDI-EXAMETAZIME

2. After radiolabelling with sodium pertechnetate (99mTc) solution, the solution of technetium (99mTc) exametazime obtained is indicated for: Neurology Technetium (99mTc) exametazime is indicated for use with single photon emission tomography (SPECT).

In brain perfusion SPECT, the diagnostic target is detection of abnormalities of regional cerebral blood flow. The following indications are sufficiently documented: - Evaluation of patients with cerebrovascular disease (specifically acute stroke, chronic ischemia, and transient ischemic attack) - Presurgical lateralization and localization of epileptogenic foci.

- Evaluation of patients with suspected dementia (specifically Alzheimer’s disease and frontotemporal dementia) - Evaluation of patients with migraine - Adjuvant technique in the diagnosis of brain death Infectious or inflammatory diseases In infectious or inflammatory diseases, the diagnostic target is tissue or structures in which labeled leukocytes are retained.

In infectious or inflammatory diseases, the following indications are sufficiently documented: - Localisation of abnormal foci guiding the aetiologic diagnosis in case of fever of unknown origin - Diagnosis of infection in case of suspected osteomyelitis (with or without implants) and suspected hip or knee prosthesis infection.

- Detection of the extension of inflammation in case of inflammatory bowel disease. 2 Posology and method of administration Posology Adults and elderly population The suggested activity range for intravenous administration to an adult patient of average weight (70 kg) is for: - Brain perfusion SPECT: 350-500 MBq - For labelled leukocyte scintigraphy: 200 MBq Renal/Hepatic impairment In case of renal or hepatic impairment, exposure to ionising radiation can be increased.

This must be taken into account when calculating the activity to be administered. Paediatric population The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group.

Safety and efficacy in paediatric population have not been fully established. Alternative techniques which do not involve ionising radiation should be especially considered. The activities to be administered to children and adolescents may be calculated according to the recommendations of the European Association of Nuclear Medicine (EANM) paediatric dosage card; the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the weight-dependent multiples given in the table below.

8 MBq for brain perfusion SPECT, and the minimum activity is 100 MBq. For labelled leukocyte scintigraphy, the baseline activity is 35 MBq and the minimum activity is 40 MBq. 00 Method of administration - Brain perfusion SPECT: intravenous use.

The radiopharmaceutical should be injected no sooner than 10 min but not later than 60 min after radioligand reconstitution. - For labelled leukocyte scintigraphy: Leukocytes are labelled in vitro and subsequently labelled leukocytes are for intravenous use.

Because of potential tissue damage extravasal injection of this radioactive product has to be strictly avoided. For multidose use. Precautions to be taken before handling or administration of the medicinal product This medicinal product should be reconstituted before administration to the patient.

For instructions on reconstitution and control of the radiochemical purity of the medicinal product of the medicinal product before administration, see section 12. For patient preparation, see section

The frequencies of undesirable effects 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) Immune system disorders Not known Re-injected labelled leukocytes only Not known Hypersensitivity including rash, erythema, urticaria, angiooedema, pruritus.

, malaise, fatigue) Other disorder Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 7 mSv when the maximal recommended activity of 500 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

4. Image acquisition Brain perfusion SPECT Imaging should be delayed 30-90 min after injection for best image quality. g. g. 120 projections, 60 projections per head, 30 s/projection). Imaging should be completed within 4 hours post injection.

Labeled leukocyte scintigraphy A large-field-of-view gamma camera with a low-energy high-resolution collimator is usually preferred. Early imaging of the pelvis and abdomen is essential (bowel activity is seen in 20%– 30% of children by 1 h and 2%–6% of adults by 3–4 h after injection).

Images of the limbs should be acquired for 10 min/view at 4–8 h and at least 15 min/view at 16–24 h (particularly for osteomyelitis). SPECT images of the chest, abdomen/pelvis,or spine may be helpful. 1 or to any of the components of the labelled radiopharmaceutical.

4 Special warnings and precautions for use Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occurs, 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 or Hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11). 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.

Brain perfusion SPECT Patients should preferably avoid excessive stimulants (such as caffeine, cola, and energy drinks), alcohol, smoking, and any drugs known to affect cerebral blood flow prior to imaging. After the procedure Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.

e. essentially ‘sodium- free’. Depending on the time when you administer the injection, the content of sodium given to the patient may in some cases be greater than 1 mmol. This should be taken into account in patient on low sodium diet.

The preparation without reconstitution with sodium 99mTc-pertechnetate must not be administered to patients. Reinjected Medi –exametazime labelled leukocytes only When preparing technetium (99mTc)-labelled leukocytes, it is essential that cells are washed free of sedimentation agents before they are re-injected into the patient as materials used in cell separation may cause hypersensitivity reactions.

Manipulation of human cells (labelling of leucocytes) carries the risk of potential transmission of infections (HBV, HIV, etc). 6.

1 or to any of the components of the labelled radiopharmaceutical.