RADPHARM MDP kit for the production of Technetium (99mTc) medronate powder for injection multidose vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
01-02-2021
Public Assessment Report
(PAR)
02-12-2017
Active ingredient:
medronic acid, Quantity: 10 mg
Available from:
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
INN (International Name):
Medronic acid
Pharmaceutical form:
Injection, powder for
Composition:
Excipient Ingredients: ascorbic acid; stannous chloride
Administration route:
Intravenous
Units in package:
10 x 10 mL vials
Prescription type:
Not scheduled. Not considered by committee
Therapeutic indications:
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) medronate may be used as a skeletal imaging pharmaceutical.
Product summary:
Visual Identification: White powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
1991-09-05
Patient Information leaflet
_ _
CMI 06.06
1
_ _
_What is in this Leaflet _
This leaflet answers some common questions about MDP
Radpharm. It does not contain all the available information
and it does not take the place of talking to your nuclear
medicine specialist.
All
medicines
and
diagnostic
agents
have
risks
and
benefits. Your referring doctor, in consultation with the
nuclear medicine specialist, has weighed the risks of you
having a procedure where you are given an MDP injection,
against the benefits they expect the procedure will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
THIS
INJECTION,
DISCUSS
THEM
WITH
YOUR
NUCLEAR
MEDICINE
SPECIALIST.
KEEP THIS LEAFLET.
You may need to read it again.
_What MDP is used for _
MDP Radpharm is used with an imaging agent to form an
image of the skeleton.
_THE IMAGING AGENT _
The
imaging
agent
used
is
a
radiotracer
called
Technetium-99m. Technetium-99m emits small amounts
of radiation similar to X-rays. A special camera, called a
gamma camera, can detect this radiation and produces an
image known as a scan. A nuclear medicine 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 specialist may be giving you MDP
to help diagnose other conditions.
Ask your nuclear medicine 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_
, which is
available from the hospital, clinic or supplier.
_ _
_ _
_ _
_ _
_Before you are given it _
Tell your nuclear medicine specialist or technologist if;
1.
YOU ARE PREGNANT
It is not known whether the injection is harmful to an
unborn baby when administered to a pregnant woman.
If you are pregnant, the nuclear medicine specialist
will
need
to
talk
to
your
referring
doctor
before
deciding whether you should have the injection.
2.
YOU ARE BREAST-FEEDING
Suspend breast-feeding for 4 hours a
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – RADPHARM MDP KIT FOR
THE PRODUCTION OF TECHNETIUM (99MTC) MEDRONATE POWDER
FOR INJECTION MULTIDOSE VIAL (MEDRONIC ACID)
1
NAME OF THE MEDICINE
Medronic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RADPHARM MDP Kit consists of sterile, pyrogen free, lyophilised
ingredients which need
reconstitution with sodium pertechnetate (99mTc) injection to produce
a technetium
[99mTc] medronate complex suitable for bone scanning. The precise
structure of the
technetium[
99m
Tc] medronate complex is not known at this time.
Each vial contains the following active ingredient and excipient as a
lyophilized powder:
Active Ingredient
10 mg of Medronic acid
Excipient
1 mg of stannous chloride
1 mg of ascorbic acid
The product contains no preservatives.
3
PHARMACEUTICAL FORM
Radpharm MDP is available as a dry white lyophilised powder in 10 mL
vacuum sealed vials
for intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Technetium [99mTc] medronate may be used as a skeletal imaging
pharmaceutical.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Recommended intravenous dose for the normal adult is 740 MBq.
2
RADIATION DOSIMETRY
Table 1.
Estimated Absorbed Dose from Intravenous Administration of
Technetium[99mTc] Medronate.
Organ
mGy/740MBq
Bone surfaces
46
Bladder wall
37
Kidneys
5.4
Red bone marrow
7.1
GT-LLI wall
2.8
Ovaries
2.6
Testes
1.8
Effective Dose:
4.3 mSv/740MBq
Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation
Dose To Patients from Radiopharmaceuticals
(1987).
Reference for Effective Dose: ICRP Publication 62, Radiological
Protection in Biomedical Research (1993).
PROCEDURE
NOTE: If there is no vacuum, discard vial and do not deliver the
sodium pertechnetate
[99mTc] injection.
1.
Place MDP Radpharm vial in a shielding container.
2.
Draw a suitable volume (2 to 8 mL) of sodium pertechnetate [99mTc]
injection eluted
from a technetium-99m generator (1 to 16 GBq), and inject into the MDP
Radpharm
vial. Mix by inversion for 20 seconds and leave standing at ro
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