Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TETROFOSMIN
TUNGGAL IDAMAN ABDI- Indonesia
TETROFOSMIN
0,23 MG
SERBUK INJEKSI
KIT @ 5 VIAL @ 0,23 MG
GE HEALTH CARE LIMITED - UK
2016-03-21
PRESENTATION Each vial contains 230 micrograms tetrofosmin (active ingredient), 0.03mg stannous chloride dihydrate, 0.32mg disodium sulphosalicylate, 1.0mg sodium D-gluconate and 1.8mg sodium hydrogen carbonate as a freeze-dried mixture sealed under nitrogen. Radiopharmaceutical kit - powder for solution for injection following reconstitution with 4-8ml of sterile Sodium Pertechnetate [ 99m Tc] Injection Ph. Eur. at a radioactive concentration not exceeding 1.5GBq/ml to yield 99m Tc-tetrofosmin injection, a diagnostic radiopharmaceutical imaging agent. The product is supplied in a 10ml clear glass vial. Packs of 2 and 5 vials are available. Labels for the reconstituted product and sanitizing swabs (containing 70% isopropyl alcohol B.P.) are provided. MANUFACTURER GE HEALTHCARE AS Oslo Plant Nycoveien 1 NO-0485 Oslo Norway 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. CONTRA-INDICATIONS Myoview is contraindicated in pregnancy and in patients with known hypersensitivity to tetrofosmin or any of the excipients. PRECAUTIONS FOR USE Breast lesions less than 1cm in diameter may not all be detected with scintimammography as the sensitivity of Myoview for the detection of these lesions is 36% (n=5 of 14, 95% CI 13% to 65%) relative to histological diagnosis. A negative examination does not exclude breast cancer especially in such a small lesion. Efficacy in the identification of auxiliary lesions has not been proven, consequently scintimammography is not indicated for staging breast cancer. In myocardial scintigraphy investigations under stress conditio Διαβάστε το πλήρες έγγραφο