INDIUM DTPA IN 111 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PENTETATE INDIUM DISODIUM IN 111

Available from:

GE HEALTHCARE CANADA INC

ATC code:

V09AX01

INN (International Name):

INDIUM 111 IN PENTETIC ACID

Dosage:

37MBq

Pharmaceutical form:

SOLUTION

Composition:

PENTETATE INDIUM DISODIUM IN 111 37MBq

Administration route:

INTRATHECAL

Units in package:

15G/50G

Prescription type:

Schedule C

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0152616001; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-07-08

Summary of Product characteristics

PRODUCT MONOGRAPH
INDIUM DTPA IN 111
(PENTETATE INDIUM DISODIUM IN 111 INJECTION)
DIAGNOSTIC RADIOPHARMACEUTICAL
GE Healthcare Canada Inc.
2300 Meadowvale Blvd.,
Mississauga, Ontario,
L5N 5P9
CONTROL #: 215028
DATE OF APPROVAL: JUNE 7, 2018
INDIUM DTPA IN 111
Pentetate Indium Disodium In 111 Injection
DESCRIPTION
GE Healthcare Indium DTPA In 111 is a diagnostic drug for intrathecal
use. It is available as a
sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to
8. At calibration time, each
milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111
(no-carrier added), 20 to
50 µg of pentetic acid, and sodium bicarbonate for pH adjustment.
_THE DRUG IS TO BE DISCARDED _
_AFTER SINGLE USE._
Radionuclide purity at calibration time is at least 99.88% with less
than 0.06%
Indium In 114 m and 0.06% Zinc Zn 65. The concentration of each
radionuclidic contaminant
changes with time. Graph 1 shows maximum concentration of each
radionuclidic impurity as a
function of time.
Graph 1 -
Radionuclidic Impurities
The chemical names are 1. Indate (2-)-
111
_In_
-,[
_N,N_
,-bis[2-[bis-(carboxymethyl) amino] ethyl]
glycinato(5-)]-,disodium; and 2. Disodium [
_N,N_
-bis[2-(carboxymethyl)amino]glycinato(5-)-
indate(2-)
111
_In_
.
Molecular formula: C
14
H
18
O
10
N
3
111
InNa
2
Molecular weight: 545.29
3
Structural formula:
PHYSICAL CHARACTERISTICS
Indium 111 decays by electron capture with a physical half-life of
67.9 hours.
1
The energies of
the photons that are useful for detection and imaging studies are
listed in Table 1.
Table 1. Principal Radiation Emission Data
1
Radiation
Mean %/Disintegration
Mean Energy (keV)
Gamma-2
90.2
171.3
Gamma-3
94.0
245.4
EXTERNAL RADIATION
The specific gamma ray constant for Indium In 111 is 3.3 R/hr-mCi at 1
cm. The half-value
thickness of lead (Pb) for Indium In 111 is 0.021 cm. To facilitate
control of the radiation
exposure from millicurie amounts of this radionuclide, a range of
values for the relative
attenuation of the radiation emitted by this radionuclide that re