Vizamyl · 4.6 Fertility, pregnancy and lactation · 1

HOS-096354 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects. Tabulated list 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, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions are listed in the Table 1 below: 8 Table 1 List of adverse reactions System Organ Class Common Uncommon Immune system disorders Anaphylactoid reaction Psychiatric disorders Anxiety Nervous system disorders Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor Eye disorders Eye swelling Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Vascular disorders Flushing Pallor Respiratory, thoracic and Dyspnoea mediastinal disorders Hyperventilation Throat irritation Gastrointestinal disorders Nausea Vomiting Dyspepsia Abdominal discomfort Oral discomfort Skin and subcutaneous tissue Facial hypoaesthesia disorders Pruritus Rash Skin tightness Swelling face Musculoskeletal and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-096350 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-096349 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. VIZAMYL should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.

HOS-096352 · has-interaction-information · PDF-Seite 7

Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medicinal products may alter VIZAMYL image results. No in vivo interaction studies have been performed. In vitro binding studies have not shown interference of flutemetamol (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.

HOS-096353 · has-pregnancy-information · PDF-Seite 7

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 irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient. 7 Pregnancy No studies have been conducted in pregnant women. No animal studies have been conducted to investigate the reproductive effects of flutemetamol (18F) (see section 5.3). Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus. Breast-feeding It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding. 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 breast- feeding, and to the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded. Close contact with infants should be restricted during the initial 24 hours following injection. Fertility No studies on fertility have been performed.

HOS-096351 · 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 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 readily available. Individual benefit/risk justification For each patient, the radiation exposure must be justified by the likely benefit. The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal /Hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. Flutemetamol (18F) is excreted largely through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure. See section 4.2. Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1. Interpretation of VIZAMYL images VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F). A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques. A positive scan indicates a moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed. PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale. The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity. The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through - The frontal lobes and anterior cingulate (f, ac, axial review) - Posterior cingulate and precuneus (pc, sagittal review) - Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) - Lateral temporal lobes (lt, axial review) - Striatal region (s, axial review) Interpretation of the images is performed visually by comparing the activity in cortical grey matter with activity in adjacent cortical white matter. - A region is considered as having a negative (normal) pattern if the tracer signal in cortical regions is low (i.e. distinctly lower signal intensity compared

Auszug; vollständigen Abschnitt im Original lesen.