STAMICIS 1 mg Kit for Radiopharmaceutical Preparation

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

Available from:

QUANTARAD TECHNOLOGIES SDN BHD

INN (International Name):

Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

Units in package:

1mg mcg/mL

Manufactured by:

CIS Bio International

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
STAMICIS 1 mg kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg [Tetrakis (2-methoxyisobutyl isonitrile)
copper (I)] tetrafluoroborate.
The radionuclide is not part of the kit.
Excipients with known effect:
One ml of solution contains 4.5 mg of sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. This is indicated
for adults. For paediatric
population see section 4.2.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the solution of technetium (
99m
Tc)
sestamibi obtained is indicated 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.
CIS bio international, Member of IBA Molecular group of companies
T3069nE-project
04/2017
2
•
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly population _
Posology may vary depending on gamma camera characteristics and
reconstruction modalities. The
injection of activities greater than local DRLs (Diagnostic Reference
Levels) should be justified.
The recommended activity range for intravenous administration to an
adult patient of