RADPHARM LEUCOCYTE LABELLING KIT injection composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium fluoride, Quantity: 1 mg/mL

Available from:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

INN (International Name):

sodium fluoride,Stannous fluoride

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: stannous fluoride

Administration route:

Intravenous

Units in package:

5xvials of solution 6mL, 5xvials of powder

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) labelled leucocytes may be used to image acute inflammation or infection.

Product summary:

Visual Identification: White powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 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 LLK
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 a LLK Radpharm
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 LLK is used for _
LLK Radpharm is used with an imaging agent to form an
image of areas of inflammation or infection that may be
present.
_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 LLK
Radpharm to help diagnose other conditions.
Ask your nuclear medicine specialist if you have any
questions about why LLK Radpharm 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – RADPHARM LEUCOCYTE
LABELLING KIT FOR THE PRODUCTION OF TECHNETIUM (99MTC)
STANNOUS FLUORIDE INJECTION COMPOSITE PACK (SODIUM
FLUORIDE)
1
NAME OF THE MEDICINE
Sodium Fluoride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RADPHARM LLK Kit consists of sterile, pyrogen free ingredients which
need
reconstitution with sodium pertechnetate [99mTc] injection and mixing
to
produce technetium [99mTc] stannous colloid complex suitable for
labelling
white blood cells in whole blood.
Each vial A (solution) and Vial B (lyophilized) contains the following
active ingredient and
excipient:
a) Vial A
6 mL solution of 1mg/mL sodium fluoride (active ingredient) in Water
for Injections BP
(excipient).
b) Vial B
0.64 mg of stannous fluoride (excipient) as a lyophilised powder.
The product contains no preservatives.
3
PHARMACEUTICAL FORM
Radpharm LLK is a composite kit consists of:
a) Vial A- clear concentrated liquid for Intravenous Injection in 10
mL vials.
b) Vial B- dry white lyophilised powder in multi-dose 8mL vacuum
sealed vials for
intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Technetium[99mTc] labelled leucocytes may be used to image acute
inflammation or
infection.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Recommended intravenous dose for the normal adult is 400 to 600 MBq.
RADIATION DOSIMETRY
Table 1.
Estimated Absorbed Dose from Intravenous Administration of
Technetium[99mTc] Labelled Leucocytes
Organ
mGy/600MBq
Adrenals
5.34
Bladder wall
1.56
Bone surfaces
7.8
Breast
1.86
GI-tract:
Stomach wall
Small intestine
ULI wall
LLI wall
4.8
2.94
2.94
2.34
Heart
5.4
Kidneys
5.9
Liver
12
Lungs
4.14
Ovaries
2.52
Pancreas
8.4
Red marrow
13.2
Spleen
90
Testes
1.02
Thyroid
1.44
Uterus
2.28
Other Tissue
2.04
EFFECTIVE DOSE
6.6 MSV/600MBQ
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).
HEPARIN PREPARATI