País: Canadá
Língua: inglês
Origem: Health Canada
TETRAKIS [CU(MIBI)4]BF4
LANTHEUS MI CANADA INC
V09GX
OTHER CARDIOVASCULAR SYSTEM DIAGNOSTIC RADIOPHARM.
1MG
POWDER FOR SOLUTION
TETRAKIS [CU(MIBI)4]BF4 1MG
INTRAVENOUS
2/5/20/30 X 5ML VIALS
Schedule C
RADIOACTIVE AGENTS
Active ingredient group (AIG) number: 0152590001; AHFS:
APPROVED
2008-11-07
PRODUCT MONOGRAPH CARDIOLITE ® (KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI FOR INJECTION) RADIODIAGNOSTIC AGENT (MYOCARDIAL IMAGING) Manufacturer: Lantheus Medical Imaging N. Billerica, MA 01862 USA Date of Authorisation: December 11, 2008 Distributor: Lantheus MI Canada, Inc. 1111 Dr. Frederik-Philips Boulevard Montreal, QC Canada Control No.: 124915 1 PRODUCT MONOGRAPH CARDIOLITE ® (KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI FOR INJECTION) THERAPEUTIC CLASSIFICATION Radiodiagnostic Agent (Myocardial Imaging) ACTION AND CLINICAL PHARMACOLOGY Each 5mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (1) tetrafluoroborate 1.0 mg Stannous Chloride, Dihydrate, minimum (SnCl 2 .2H 2 O) 0.025 mg Sodium Citrate Dihydrate 2.6 mg Total Tin, maximum (SnCl 2 . 2H 2 O) 0.086 mg L-Cysteine Hydrochloride Monohydrate 1.0 mg Mannitol 20 mg Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0-6.0). No bacteriostatic preservative is present. The precise structure of the technetium complex is Tc99m [MIBI]+ 6 where MIBI is 2- methoxy isobutyl isonitrile. PHYSICAL CHARACTERISTICS Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours*. Photons that are useful for detection and imaging studies are listed in Table 1. TABLE 1 PRINCIPLE RADIATION EMISSION DATA RADIATION MEAN % DISINTEGRATION MEAN ENERGY (KEV) Gamma-2 89.07 140.5 *Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981). 2 EXTERNAL RADIATION The specific gamma ray constant for Tc99m is 5.4 microcoulombs/Kg-MBq-hr (0.78 R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this r Leia o documento completo