DRAXMIBI Kit for radiopharmaceutical preparation 1 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE
Available from:
DRAXIMAGE (UK) Limited
Dosage:
1 Milligram
Pharmaceutical form:
Kit for radiopharmaceutical preparation
Authorization date:
2009-07-10
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DRAXMIBI 1 mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains:
Active substance
Tetrakis(2-methoxyisobutylisonitrile)copper(I) Tetrafluoroborate 1 mg
Excipients:
This medicinal product contains 0.61 mg of Sodium per vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Lyophilized, white powder.
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection (not included in this kit).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with sodium technetium pertechnetate (
99m
Tc) solution for injection, the solution of technetium
(
99m
Tc) sestamibi obtained is indicated for:
MYOCARDIAL PERFUSION SCINTIGRAPHY
Detection and localization 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/08/2011_
_CRN 2094519_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use.
The suggested activity range for intravenous administration to a
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