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Product information
MEDI-MIBI 500 MICROGRAMS
Active substance
Sestamibi [tetrakis (1 isocyanide-2-methoxy-2-methylpropyl-) copper(I)] tetrafluoroborate 0.5 mg
Indications
The Tc-99m labelled compound can be used for
- Myocardial perfusion scintigraphy for the detection and localisation of coronary artery disease
(angina pectoris 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.
- Scintimammography for the detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate.
- Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands.
Excipients
- Stannous(II) chloride dihydrate
- Sodium chloride
- Tetrasodium pyrophosphate decahydrate
- L-cysteine hydrochloride monohydrate
- Glycine
Dose for adults
Diagnosis of reduced coronary perfusion and myocardial infarction:
- 400 – 900 MBq
Diagnosis of ischaemic heart disease:
- Two-day protocol: 600–900 MBq/study
- One-day protocol: 400–500 MBq
Assessment of global ventricular function
- 600-800 MBq injected as a bolus
Scintimammography:
- 700 - 1000 MBq injected as a bolus
Localisation of hyperfunctioning parathyroid tissue:
- 200 - 700 MBq injected as a bolus
Labelling volume
1-5 ml
Labelling activity
Up to 15 GBq
Storage of cold kit
30 months from date of manufacturing,
Do not store above 25°C
Protect from light
Storage of labelled compound
8 hrs,
Do not store above 25°C
Package size
6 vials
Registration numbers
Denmark: DK.R.2236
Austria: 4-00035
Spain: 70755
Italy: 040312011
Croatia: HR-H-769142649
Republic of Belarus: 10057/12/18
Hong-Kong: HK-64680
Taiwan: R00098
Marketing Authorization Holder
Medi-Radiopharma Co., Ltd.
2040 Budaörs, Gyár u. 2., Hungary
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