Scintimun · 4.3 Contraindications · 1

HOS-095380 · has-adverse-reaction-information · PDF-Seite 5

In the most recent clinical study in which 123 patients were administered Scintimun, the most commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14 % of the patients, after a single administration (16 positive over 116 assayed one and/or three months after the administration). The table below reports adverse reactions by MedDRA system organ classes. The frequencies are based on the most recent clinical trial and non interventional safety survey. The frequency listed below is defined using the following convention: 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) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA System Organ Adverse reactions Frequency Classes Immune system disorders Anaphylactic/anaphylactoid reaction Rare Hypersensitivity, including angioedema, Uncommon urticaria Vascular disorders Hypotension Common Musculoskeletal and connective Myalgia, arthralgia Rare tissue disorders Investigations Human anti-mouse antibody positive Very common Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations the frequency of these adverse 5 reactions is not known. As the effective dose is about 6.9 mSv when the maximal recommended activity of 800 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

HOS-095376 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, to other murine antibodies, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical. Positive screening test for human anti-mouse antibody (HAMA). Pregnancy (see section 4.6).

HOS-095375 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. 99m 99m After radiolabelling with sodium pertechnetate ( Tc) solution, the technetium ( Tc) besilesomab solution obtained is indicated in adults for scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.

HOS-095378 · has-interaction-information · PDF-Seite 4

Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics and corticosteroids) may lead to false negative results. Such substances should therefore not be administered together with, or a short time before the injection of Scintimun.

HOS-095379 · has-pregnancy-information · PDF-Seite 4

4 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 very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient. Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3). Breast-feeding It is not known if the product is excreted in human milk. A risk to a breast-fed child cannot be excluded. 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 what is 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 three days and the expressed feeds discarded. These three days correspond to 10 half-lives of technetium (99mTc) (60 hours). At that time the remaining activity represents about 1/1000 of the initial activity in the body. Close contact with infants should be restricted during the first 12 hours after the injection.

HOS-095377 · has-warning-information · PDF-Seite 3

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. Since allergic reactions to the murine protein cannot be excluded, cardiovascular treatment, corticosteroids, and antihistamines must be available during administration of the product. 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. Patient preparation Scintimun should be given to sufficiently hydrated patients. In order to obtain images of best quality and to reduce the radiation exposure of the bladder, patients should be encouraged to drink sufficient amounts and to empty their bladder prior to and after the scintigraphic examination. An interval of at least 2 days must be observed between any previous scintigraphy with other technetium (99mTc)-labelled agents and administration of Scintimun. 3 Interpretation of images There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging. Scintimun images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations. Only limited data is available about binding of technetium (99mTc) besilesomab to CarcinoEmbryonic Antigen (CEA) expressing tumours in vivo. In vitro, besilesomab cross-reacts with CEA. False positive findings in patients with CEA expressing tumours cannot be excluded. False results may be obtained in patients with diseases involving neutrophil defects and to patients with haematological malignancies including myeloma. After the procedure Close contact with infants and pregnant women should be restricted during the first 12 hours after the injection. Specific warnings Fructose intolerance This medicine contains 2 mg sorbitol in each vial of Scintimun. Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodi

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