CARDIOLITE POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TETRAKIS [CU(MIBI)4]BF4

זמין מ:

LANTHEUS MI CANADA INC

קוד ATC:

V09GX

INN (שם בינלאומי):

OTHER CARDIOVASCULAR SYSTEM DIAGNOSTIC RADIOPHARM.

כמות:

1MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

TETRAKIS [CU(MIBI)4]BF4 1MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

2/5/20/30 X 5ML VIALS

סוג מרשם:

Schedule C

איזור תרפויטי:

RADIOACTIVE AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0152590001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2008-11-07

מאפייני מוצר

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