देश: साइप्रस
भाषा: यूनानी
स्रोत: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
TETROFOSMIN
GE HEALTHCARE AS (NYDALEN) (0000010815) NYDALEN, OSLO, NO-0401, 4220
V09GA02
TECHNETIUM (99MTC) TETROFOSMIN
0.23MG
KIT FOR RADIOPHARMACEUTICAL PREPARATION
TETROFOSMIN (8000001935) 0,23MG
INTRAVENOUS USE
Εθνική Διαδικασία
TECHNETIUM (99mTc) TETROFOSMIN
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 5 VIALS X 0.23MG (230025202) 5 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
than 5% of the administered activity remains in whole blood at 10 minutes post- injection. Background tissue clearance is rapid from lung and liver and activity is reduced in these organs following exercise, with enhanced sequestration in skeletal muscle. Approximately 66% of the injected activity is excreted within 48 hours post- injection, with approximately 40% excreted in the urine and 26% in the faeces. MYOCARDIAL UPTAKE: Uptake in the myocardium is rapid, reaching a maximum of about 1.2% of injected dose with sufficient retention to allow imaging of the myocardium by planar or SPECT techniques from 15 minutes up to 4 hours post-administration. PRECLINICAL SAFETY DATA Acute toxicity studies employing Myoview at dosage levels of approximately 1050 times the maximum human single dose failed to reveal mortality or any significant signs of toxicity in rats or rabbits. In repeated dose studies some evidence of toxicity was observed in rabbits, but only at cumulative doses exceeding 10,000 times the maximum human single dose. In rats receiving these doses there was no significant evidence of toxicity. Studies on reproductive toxicity have not been conducted. Tetrofosmin showed no evidence of mutagenic potential in _in _ _vitro_ or _in _ _vivo_ mutagenicity studies. Studies to assess the carcinogenic potential of Myoview have not been performed. RADIATION DOSIMETRY Estimated absorbed radiation doses for an average adult patient (70kg) from intravenous injections of 99mTc-tetrofosmin are listed below. The values are calculated assuming urinary bladder emptying at 3.5 hour intervals. Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure. 6. Cut the strip into 3 pieces at the marked cutting positions and measure the activity on each using suitable counting equipment. Try to ensure similar counting geometry for each piece and minimize equipment dead time losses. 7. Calculate the radiochemical purity from: % 99m Tc-tetrofosmin = Activity of centre piece x 100 Total activity of all पूरा दस्तावेज़ पढ़ें