MDP Kit for preparation of Technetium(99mTc) medronate powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

medronic acid

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

Medronic acid

Authorization status:

Registered

Patient Information leaflet

1
MDP SKELETAL AGENT
MDP KIT FOR THE PREPARATION OF TECHNETIUM (
99M
TC) MEDRONATE
POWDER FOR INJECTION – MULTIDOSE VIAL
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about MDP Skeletal Agent,
otherwise
known as Methylene Diphosphonic Acid (Medronic Acid). It does not
contain all the
available information.
It does not take the place of talking to your nuclear medicine
physician or specialist. All
medicines have potential risks and benefits associated with them. Your
nuclear medicine
physician or specialist has weighed the small risks of you being
treated with an MDP
injection 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 specialist.
KEEP THIS LEAFLET. You many need to read it again.
WHAT MDP IS USED FOR
MDP Skeletal Agent is used with an imaging agent (radiotracer) to form
an image of the
skeleton.
THE IMAGING AGENT
The imaging agent used is a radio tracer 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 with information
related to your referral that otherwise may not be known or seen on
plain X-rays.
Your nuclear medicine physician or specialist may be giving you MDP to
help diagnose
other conditions. Ask your nuclear medicine physician or specialist if
you have any
questions about why MDP 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 supplier. MDP SKELETAL AGENT
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Summary of Product characteristics

DESCRIPTION
Each vial contains 10 mg medronic acid,
0.84 mg Tin(II) Chloride and 2.0 mg of
ascorbic acid. Hydrochloric acid is used in the
manufacture. Before lyophilisation the pH is
adjusted to 5.0 with sodium hydroxide solution.
The contents of the vial are lyophilized and
stored under nitrogen.
As supplied the product is sterile and pyrogen
free. It contains no preservative.
The product is designed for diagnostic use.
Use by intravenous administration after
reconstitution with sodium pertechnetate
(
99m
Tc) injection.
PHYSICAL CHARACTERISTICS OF
99M
TC
Technetium-99m with a physical half life of six
hours, decays by isomeric transition to
99
Tc.
Photons associated with this transition that are
useful for detection and imaging studies are
TABLE 1
PRINCIPAL RADIATION EMISSION DATA
Reference: “D A Weber, K F Eckerman, LT
Dillman and JC Ryan. MIRD: Radionuclide
and Decay Schemes.” The society of Nuclear
Medicine Inc.
New York, 1989.
TABLE 2:
PHYSICAL DECAY CHART OF
99M
TC
EXTERNAL RADIATION
The specific gamma ray constant for
99m
Tc
half value thickness of lead (Pb) for
99m
Tc is
0.2mm. Attenuation by lead is given in the
following table:
TABLE 3:
RADIATION ATTENUATION BY LEAD SHIELDING
MDP SKELETAL AGENT
_I_
P
RODUCT
I
NFORMATION
PRINCIPAL
MEAN % PER
MEAN ENERGY (KEV)
RADIATION
DISINTEGRATION
Gamma-2
89.1
140.5
HOURS
FRACTION
HOURS FRACTION
REMAINING
REMAINING
0
1.000
7
0.445
1
0.891
8
0.397
2
0.794
9
0.354
3
0.707
10
0.315
4
0.630
11
0.281
5
0.561
12
0.250
6
0.500
SHIELD THICKNESS
COEFFICIENT OF ATTENUATION
MM PB
0.95
0.1
1.8
0.01
2.7
0.001
3.6
0.0001
-h
is 0.19mGy per MBq at 1 cm. The first
listed in Table 1.
PHARMACOLOGY
Upon intravenous injection, skeletal uptake of
technetium (
99m
Tc) MDP appears to be related
to bone metabolic activity and to skeletal blood
flow. Technetium (
99m
Tc) MDP exhibits a
specific affinity for areas of altered osteogenesis.
Localized areas of decreased skeletal accumulation
of technetium (
99m
Tc) MDP may be seen after
therapeutic external irradiation. Technetium
(
99m
Tc) M