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    Active Ingredient
    Tetrakis 1 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 X 15 ml

    not in the basket chart

    Related information


    Dosage

    Adults: The suggested activity range for intravenous use to a patient of average weight (70 kg) is:
    Myocardial perfusion scintigraphy: 400-900 MBq.
    Assessment of global ventricular function: 600-800 MBq injected as a bolus.
    For diagnosis of ischaemic heart disease two injections (stress and rest) are required in order to differentiate transiently from persistently reduced myocardial uptake.
    The recommended activity range for diagnosis of ischaemic heart disease according to the European procedural guideline is:
    Two-day protocol: 600–900 MBq/study.
    One-day protocol: 400–500 MBq for the first injection, three times more for the second injection.
    Not more than a total of 2000 MBq should be administered for a one-day protocol and 1800 MBq for a two-day-protocol. For a one day protocol, the two injections (stress and rest) should be done at least two hours apart but may be performed in either order. After the stress injection, exercise should be encouraged for an additional one minute (if possible).
    For diagnosis of myocardial infarction one injection at rest may be sufficient. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified.
    Scinti-mammography for the detection of suspected breast cancer: 750-1000 MBq injected as a bolus in the arm opposite to the lesion.
    Localisation of hyperfunctioning parathyroid tissue: 200-1000 MBq injected as a bolus (the activity used should in every case be as low as reasonably practical). The typical activity is 740 MBq.
    Children & Adolescents: Safety and efficacy in children and adolescents below the age of 18 have not been fully established. Alternative techniques which do not involve ionising radiation should be especially considered.
    The use technetium (99mTc) sestamibi in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activities to be administered for paediatric patients should be modified according to the recommendations of the Paediatric Task Group of the EANM (1990). This activity can be determined from the recommended activity for adults on the basis of body mass, using the following multiplying coefficient: See prescribing information for full details.
    For Method of administration and scintigraphic examination, please refer to prescribing information.


    Indications

    This medicinal product is for diagnostic use only.
    After reconstitution with sodium pertechnetate (99mTc) solution for injection, the solution of technetium (99mTc) sestamibi obtained is indicated for:
    Myocardial perfusion scintigraphy: Detection and localisation of coronary artery disease and myocardial infarction.
    Assessment of global ventricular function: First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion.
    Scinti-mammography for the detection of suspected breast cancer: Detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate.
    Localisation of hyperfunctioning parathyroid tissue: In patients with recurrent or persistent hyperparathyroidism, and in patients scheduled to undergo surgery of the parathyroid glands.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients.


    Special Precautions

    If hypersensitivity or anaphylactoid 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.
    Proper hydration and frequent voiding during the first few hours after injection are necessary to reduce bladder irradiation.
    In newborns, infants, children and adolescents, special attention should be paid to the effective dose per MBq which is higher than in an adult. See prescribing information for full details.
    In myocardial scintigraphy investigations under stress conditions, the general contraindications and precautions associated with the induction of ergometric or pharmacological stress should be considered.
    See prescribing information for full details.


    Side Effects

    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.
    See prescribing information for full details.


    Drug interactions

    No drug interactions have been described to date.
    Medicinal products which affect myocardial function and/or blood fl ow may cause false negative results in the diagnosis of coronary arterial disease. For this reason, concomitant medication should be taken into consideration when
    interpreting the results of the scintigraphic examination.


    Pregnancy and Lactation

    Pregnancy: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
    Lactation: If the administration of the radioactive medicinal product is considered necessary, breast feeding should be interrupted for 24 hours and the expressed feeds discarded.
    Close contact with infants should be restricted during this period.
    See prescribing information for full details.


    Overdose

    In the event of administration of a radiation overdose with technetium (99mTc) sestamibi the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defecation.


    Important notes

    Compatibility: This medicinal product must not be mixed with other medicinal products except: Sodium Pertechnetate (99mTc) Injection, Ph. Eur.
    See prescribing information for full details.


    Manufacturer
    CIS BIO International
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