INDIUM(111In) Oxine solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indium (111In) hydroxyquinoline, Quantity: 0.01 microgram/mL (Equivalent: indium (111In) chloride, Qty 37 MBq/mL)

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; hepes; oxyquinoline; polysorbate 80

Administration route:

Intravenous

Units in package:

1mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For in vitro radiolabelling of separated leucocytes and platelets which are subsequently reinjected intravenously for investigative purposes using appropriate imaging/counting procedures.

Product summary:

Visual Identification: Clear colourless or faint straw coloured solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Days; Container Temperature: Store between 15-25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-05-04

Patient Information leaflet

1-020605
INDIUM [111IN] OXINE SOLUTION
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about
Indium [
111
In] Oxine
solution.. It does not contain all the
available information, nor does it take
the place of talking to your doctor or
treatment provider.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being treated with Indium [
111
In]
Oxine solution
against the expected benefits.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
THIS
PREPARATION,
ASK
YOUR DOCTOR OR TREATMENT PROVIDER.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT INDIUM [111IN]
OXINE SOLUTION IS USED
FOR
Indium
[
111
In]
Oxine
solution
is
a
radiopharmaceutical
which
is
a
medicinal product containing a small
amount
of
radioactivity.
Such
radiopharmaceuticals
are
given
in
small amounts to find out or rule out a
disease. A sample of your blood will
be taken and mixed with the product to
label
some
of
the
blood
cells
with
radioactivity. This blood sample will
be re-injected into your body to help to
find infections such as abcesses in your
abdomen, infections inside your bones
and
other
types
of
infections
and
conditions.
The
radiation
that
your
body
receives
is
very
low
and
is
considered
safe.
The
labelled
blood
cells circulate in the body and may
temporarily collect in a particular area
of
tissue.
The
radioactivity
can
be
detected from outside the body using
special cameras, and a picture, known
as a scan, can be taken. This scan will
show
the
distribution
of
the
radioactivity
within
your
body.
This
can
give
the
doctor
valuable
information
about
the
location
of
inflammation or possible tissue damage
or disease
Your
doctor
will
explain
for
which
particular
purpose
he/she
is
using
Indium [
111
In] Oxine solution.
Indium [
111
In] Oxine solution is used to
find out or rule out a diagnosis only. It
is not used to treat or cure a disease.
Ask
your
doctor
if
you
have
any
questions
about
why
Indium
[
111
In]
Oxine solution has been prescribed for
you.
BEFORE YOU ARE G

Summary of Product characteristics

11. Withdraw half the volume (~2.5 mL) of the platelet-poor plasma
prepared in step 4 into a
20 mL syringe. Withdraw the labelled cell suspension into the same
syringe, leaving a residual
volume of 0.2 - 0.5 mL in the tube. (This residue will contain any
clumps of leucocytes which have
settled during incubation and should be discarded.) Remove the syringe
needle and transfer the
syringe contents to another 15 mL conical tube.
12. Centrifuge the capped tube at 80 - 90g for 7 minutes. Decant the
supernatant and resuspend the
cell pellet in 10 mL saline as described in step 6.
13. Withdraw the remaining volume of platelet-poor plasma (step 4)
into a fresh 20 mL syringe and
withdraw the
111
In-labelled cell suspension into the same syringe. Measure the total
activity
present and if necessary discard any excess volume to leave the
required patient dose.
14. Administer the
111
In -labelled leucocyte suspension by slow intravenous injection using
a 19G
needle.
PROCEDURE FOR THE PREPARATION AND ADMINISTRATION OF INDIUM-111
LABELLED PLATELETS
Aseptic technique should be used throughout.
Good pharmaceutical practice for the preparation of sterile solutions
should be followed. All sterile
solutions should be freshly prepared. Analytical grade chemicals
should be used throughout.
This procedure for the Indium-111 labelling of the patient’s own
platelets is described by Hawker et
al. HAWKER RJ, HAWKER LM and WILKINSON AR. Indium [
111
In] labelled human platelets: optimal
method. Clinical Science. Vol 58, pp243-248, 1980. The procedure takes
approximately 1 hour and
aseptic technique must be used throughout.
PLATELET HANDLING
The following general points should be noted in connection with the
procedure.
(1)
Turbulence and frothing during pipetting stages should be particularly
avoided, especially when
the platelet pellet is resuspended.
(2)
Damage to platelets may result from sudden temperature changes.
(3) Tubes should be kept stoppered whenever possible to avoid pH
changes.
(4) Platelets should never be passed through a n