MYOVIEW 30ML POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TETROFOSMIN

Fáanlegur frá:

GE HEALTHCARE CANADA INC

ATC númer:

V09GA02

INN (Alþjóðlegt nafn):

TECHNETIUM (99m Tc) TETROFOSMIN

Skammtar:

1.38MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

TETROFOSMIN 1.38MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Schedule C

Lækningarsvæði:

ROENTGENOGRAPHY

Vörulýsing:

Active ingredient group (AIG) number: 0152605002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2014-03-07

Vara einkenni

PRODUCT MONOGRAPH
MYOVIEW
TM
30 ML
[Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection]
Radiodiagnostic Agent
GE HEALTHCARE CANADA INC.
2300 Meadowvale Blvd.,
Mississauga, Ontario,
L5N 5P9
CONTROL NO.:
211074
DATE OF APPROVAL:
February 12, 2018
1
NAME OF DRUG
MYOVIEW
TM
30 mL [Kit for the Preparation of Technetium Tc99m Tetrofosmin
Injection]
Radiodiagnostic Agent
For intravenous use only
DESCRIPTION
The Myoview 30 mL kit is supplied as a package of five multidose vials
for use in the preparation
of a technetium Tc99m tetrofosmin intravenous injection to be used for
scintigraphic imaging
studies for the delineation of regions of reversible myocardial
ischemia in the presence or absence
of infarcted myocardium. Each vial contains a predispensed, sterile,
non-pyrogenic, lyophilized
mixture of 1.38 mg tetrofosmin
[6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane],
0.09 mg stannous chloride dihydrate (minimum stannous tin 0.015 mg;
maximum total stannous
and stannic tin 0.0522 mg), 1.92 mg disodium sulphosalicylate, 3 mg
sodium D-gluconate, 11 mg
sodium hydrogen carbonate, and 3 mg ascorbic acid. The lyophilized
powder is sealed under a
nitrogen atmosphere with a rubber closure. The product contains no
antimicrobial preservative.
When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic
saline is added to the vial, a
Tc99m complex of tetrofosmin is formed. The pH of the reconstituted
vial is 7.5-9.0.
Administration is by intravenous injection for diagnostic use.
PHYSICAL CHARACTERISTICS
Technetium Tc99m decays by isomeric transition with a physical
half-life of 6.02 hours.
(1)
Photons that are useful for imaging studies are listed in Table 1.
TABLE 1 PRINCIPAL RADIATION EMISSION DATA - TECHNETIUM TC99M
RADIATION MEAN %
MEAN ENERGY
/DISINTEGRATION (KEV)
Gamma 2
87.87
140.5
2
EXTERNAL RADIATION
The specific gamma ray constant for technetium Tc99m is 206
microCoulomb.kg
-1
/37 MBq-hr
(0.8 R/mCi-hr) at 1 cm. The first half-value thickness of lead (Pb)
for technetium Tc99m is 0.2
mm. A ran