MYOVIEW FOR INJECTION 0.23 MG/VIAL [SIN11820P]

Product Info

MYOVIEW FOR INJECTION 0.23 MG/VIAL

[SIN11820P]

Indications

This medicinal product is for diagnostic use only.

Myocardial Imaging:

Myoview™ is a myocardial perfusion agent indicated as an adjunct in the diagnosis and localization of myocardial ischaemia and/or infarction.

Breast Tumour Imaging:

Myoview™ is indicated as an adjunct to the initial assessments (e.g palpation, mammography, or alternative imaging modalities and/or cytology) in the characterisation of malignancy of suspected breast lesions where all these other recommended tests were inconclusive.

Dosage and administration

Paediatric Population

Myoview™ is not recommended for use in children or adolescents as data are not available for these age groups.

Adults

Myocardial Imaging
Patients should be requested to fast overnight or to have only a light breakfast on the morning of the procedure.

For the diagnosis and localization of myocardial ischaemia the recommended procedure involves two intravenous injections of ^99m Tc-Tetrofosmin. For adults and the elderly 185–250MBq is given at peak exercise, followed by 500–750MBq given at rest approximately 4 hours later. The activity administered should be restricted to 1000MBq in any one day.

As an adjunct in the diagnosis and localization of myocardial infarction, one injection of ^99m Tc-Tetrofosmin (185–250MBq) at rest is sufficient.

Planar or preferably SPECT imaging should begin no earlier than 15 minutes post-injection. There is no evidence for significant changes in myocardial concentration or redistribution of ^99m Tc-Tetrofosmin, therefore, images may be acquired up to at least four hours post-injection. For planar imaging the standard views (anterior, LAO 40°–45°, LAO 65°–70° and/or left lateral) should be acquired.

Breast Imaging
For the diagnosis and localization of suspected breast lesions, the recommended procedure involves a single intravenous injection of ^99m Tc-Tetrofosmin between 500–750MBq. The injection should preferably be given in a foot vein or a site other than the arm on the side of the suspected breast lesion. The patient does not need to fast before the injection.

Breast imaging is optimally initiated 5–10 minutes post-injection with the patient in the prone position with the breast(s) freely pendant. A special imaging couch designed for nuclear medicine breast imaging is recommended. A lateral image of the breast suspected of containing the lesions should be obtained with the camera face as close to the breast as is practicable.

The patient should then be repositioned so that a lateral image of the pendant contralateral breast can be obtained. An anterior supine image may then be obtained with the patient’s arms behind her head.

Contra-indications

Myoview™ is contraindicated in pregnancy and in patients with known hypersensitivity to tetrofosmin or any of the excipients.