PENTASTAN Kit for preparation of Technetium(99mTc) pentetate powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pentetic acid, Quantity: 5 mg

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: stannous chloride dihydrate; sodium chloride

Administration route:

Intravenous

Units in package:

5mg x 5

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

99mTc-Pentastan may be used to perform kidney-imaging, brain imaging, to assess renal perfusion and to estimate glomeruler filtration rate.

Product summary:

Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 8 degrees Celsius (refrigerate)

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

PENTASTAN DTPA REAGENT
1
PENTASTAN DTPA REAGENT
(PENTASTAN KIT FOR THE PREPARATION OF TECHNETIUM (
99M
TC) PENTETATE POWDER FOR INJECTION
)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Pentastan DTPA*
Reagent (also
known as Pentetic Acid). It does not contain all the available
information and it does not
take the place of you talking to your nuclear medicine specialist.
All medicines have potential risks and benefits associated with their
use. Your nuclear
medicine physician or specialist has weighed the small risk of you
being treated with
DTPA against the benefits it is expected you will receive from it.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS INJECTION, DISCUSS
THEM
WITH YOUR NUCLEAR MEDICINE PHYSICIAN OR SPECIALIST.
KEEP THIS LEAFLET. You many need to read it again.
WHAT DTPA IS USED FOR
DTPA Reagent is used with an imaging agent (radiotracer) to study
renal (kidney)
function and blood flow surrounding the brain.
THE IMAGING AGENT
The imaging agent used is a radiotracer called Technetium-99m.
Technetium-99m emits
small amounts of radiation similar to X-rays. This radiation can be
detected by a special
camera, called a gamma camera, and produces an image known as a scan.
A nuclear
medicine physician or specialist interprets these scans and provides
you and your doctor
with information related to your referral that otherwise may not be
known.
Your nuclear medicine physician or specialist may be giving you DTPA
to help diagnose
other conditions. Ask your nuclear medicine physician or specialist if
you have any
questions about why DTPA is being given to you or why you have been
referred for a
scan.
For more information, ask for a copy of the booklet “_Nuclear
Medicine – Answering your _
_Questions_” available from the hospital, clinic or the supplier.
PENTASTAN DTPA REAGENT
•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

Summary of Product characteristics

DESCRIPTION
Each vial contains 5 mg of DTPA (Pentetic
Acid), 250 micrograms (μg) of tin (II) chloride
(equivalent to 210μg of anhydrous stannous
chloride) and 4 mg of sodium chloride. The
contents of the vial are lyophilised and stored
under vacuum. The product is sterilised by
gamma irradiation.
As supplied the product is sterile and pyrogen free.
The product contains no bactericide.
The product is designed for diagnostic use.
Administration after reconstitution with sterile
sodium pertechnetate
99m
Tc solution is by
intravenous injection.
PHYSICAL CHARACTERISTICS OF
99M
TC
Technetium-99m, with a physical half-life
of six hours, decays by isomeric transition to
technetium-99. Photons associated with this
transition which are useful for detection and
TABLE 1
TABLE 2:
PHYSICAL DECAY CHART OF
99M
TC
EXTERNAL RADIATION
The specific gamma ray constant for
99m
Tc
value thickness of lead for
99m
Tc is 0.2mm. A
range of values for the relative attenuation of
the radiation emitted by
99m
Tc resulting from
the interposition of various thicknesses of lead
TABLE 3:
PENTASTAN DTPA REAGENT
SINGLE DOSE VIALS
PRINCIPAL
MEAN % PER
MEAN ENERGY (KEV)
RADIATION
DISINTEGRATION
Gamma-2
87.2
140.5
HOURS
FRACTION
HOURS FRACTION
REMAINING
REMAINING
1.000
0
5
0.562
1
0.891
6
0.501
2
0.794
7
0.447
3
0.708
8
0.398
4
0.631
SHIELD THICKNESS
COEFFICIENT OF ATTENUATION
MM PB
(APPROX)
0.2
0.5
0.95
0.1
1.8
0.01
2.7
0.001
3.6
0.0001
is shown in Table 3.
chart is listed in Table 2.
imaging studies are listed in Table 1. A decay
_I_
P
RODUCT
I
NFORMATION
-h
is 0.19mGy per MBq at 1cm. The first half
ACTIONS
Following intravenous injection,
99m
Tc-DTPA is
rapidly distributed throughout the extracellular
fluid space, where it is promptly cleared from
the body by glomerular filtration. There is
minimal binding to the renal parenchyma.
99m
Tc-DTPA tends to accumulate in
intercranial lesions with excessive neovascularity
or an altered blood-brain barrier. The agent
does not accumulate in the choroid plexus.
Since the agent is excreted by glomerular