Source: European Medicines Agency (EU) Revision Year: 2016 Publisher: CIS bio international, B.P.32, F-91192 Gif sur-Yvette Cedex
Hypersensitivity to the active substances to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
In myocardial scintigraphy investigations under stress conditions, the general contraindications associated with the induction of ergometric or pharmacological stress should be considered.
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.
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.
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible (see section 4.2).
For information on the use in paediatric population, see section 4.2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).
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.
If possible, patients should fast for at least four hours prior to the study. It is recommended that patients eat a light fatty meal or drink a glass or two of milk after each injection, prior to imaging. This will promote rapid hepatobiliary clearance of technetium (99mTc) sestamibi resulting in less liver activity in the image.
Breast lesions less than 1 cm in diameter may not all be detected with scintimammography as the sensitivity of technetium (99mTc) sestamibi for the detection of these lesions is low. A negative examination does not exclude breast cancer especially in such a small lesion.
Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
In myocardial scintigraphy investigations under stress conditions, the general contraindications and precautions associated with the induction of ergometric or pharmacological stress should be considered.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree’.
For precautions with respect to environmental hazard see section 6.6.
Medicinal products which affect myocardial function and/or blood flow may cause false negative results in the diagnosis of coronary arterial disease. Particularly beta-blockers and calcium antagonists reduce oxygen consumption and thus also affect perfusion and beta-blockers inhibit the increase of heart frequency and blood pressure under stress. For this reason, concomitant medicinal product should be taken into consideration when interpreting the results of the scintigraphic examination. The recommendations of the applicable guidelines on ergometric or pharmacological stress tests should be followed.
When the subtraction technique is used for imaging of hyperfunctioning parathyroid tissue, recent use of iodine containing radiologic contrast media, medicinal products used to treat hyper- or hypothyroidism or of several other medicinal products is likely to decrease the quality of thyroid imaging and even makes subtraction impossible. For a complete list of possibly interacting medicinal products refer to the SmPCs of sodium iodide (123I) or sodium pertechnetate (99mTc).
Interaction studies have only been performed in adults.
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.
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.
Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, 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, breastfeeding 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.
No studies on fertility have been performed.
STAMICIS has no or negligible influence on the ability to drive and use machines.
The following table presents how the frequencies are reflected in this section: 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).
Rare: Severe hypersensitivity reactions such as dyspnoea, hypotension, bradycardia, asthenia and vomiting (usually within two hours of administration), angioedema. Other hypersensitivity reactions (allergic skin and mucosa reactions with exanthema (pruritus, urticaria, oedema), vasodilatation).
Very rare: Other hypersensitivity reactions have been described in predisposed patients.
Uncommon: Headache.
Rare: Seizures (shortly after administration), syncope.
Uncommon: Chest pain/angina pectoris, abnormal ECG.
Rare: Arrhythmia.
Uncommon: Nausea.
Rare: Abdominal pain.
Rare: local reactions at the injection site, hypoaesthesia and paraesthesia, flushing.
Not known: Erythema multiforme.
Common: Immediately after injection, a metallic or bitter taste, partly in combination with dry mouth and an alteration in the sense of smell may be observed.
Rare: Fever, fatigue, dizziness, transient arthritic-like pain.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 16.4 mSv when the maximal recommended activity of 2000 MBq (500 at rest and 1500 MBq at stress) for a 1-day-protocol is administered these adverse reactions are expected to occur with a low probability.
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.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
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