METASTRON strontium(89Sr) chloride 150 MBq/4mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

strontium(89Sr) chloride, Quantity: 37 MBq/mL

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: strontium chloride; water for injections

Administration route:

Intravenous

Units in package:

1 X 10mL vial

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 20 MAY 2005 : For the palliation of pain from sclerotic bone metastases secondary to prostate carcinoma in patients who have not responded, or who are no longer responding to conventional therapies, including external beam radiotherapy. As an alternative to external beam therapy for the palliation of pain from bone metastases secondary to prostatic carcinoma at the stage of hormone therapy failure.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 28 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-07-21

Patient Information leaflet

1-020605
METASTRON™
_Strontium [_
_89_
_Sr] Chloride Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
METASTRON.
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 METASTRON
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR
OR
NUCLEAR
MEDICINE
TECHNOLOGIST
GIVING YOU METASTRON.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT METASTRON IS
USED FOR
METASTRON contains strontium Sr-
89,
which
sends
out
radioactive
radiation for some time also known as a
radionuclide
or
radioisotope.
Radionuclide
agents may be used in
low
doses
to
help
diagnose
certain
conditions.
When
given
in
higher
doses, some radionuclides can be used
as treatments for certain conditions, as
is the case with METASTRON.
The purpose of METASTRON is to
relieve
bone
pain
that
is
caused
by
prostate
cancer.
METASTRON
is
a
bone-seeking substance which delivers
most
of
the
radiation
to
the
painful
bone lesions and spares other organs.
Therefore
it
will
not
relieve
tumour
pain outside the bone and it is not a
cure for cancer .
It may take about 10 to 20 days after a
dose of METASTRON before you feel
any relief of pain. Sometimes the pain
flares up for a few days after you have
received METASTRON. You will then
be given pain killers.
BEFORE YOU ARE GIVEN
METASTRON
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU
MUST
NOT
BE
GIVEN
METASTRON IF YOU HAVE:

Severe problems with your bone
marrow which cause the blood to
contain very low levels of some
types of white blood cells (which
help
fight
infection)
or
platelets
(which control blood clotting).
METASTRON is also not suitable as a
major treatment where there is pressure
on your spinal cord from a tumour or
bony fragment of spine.
_BEFORE YOU ARE GIVEN IT _
YOUR DOCTOR MUST KNOW ABOUT ALL OF
THE FOLLOWING BEFORE YO

Summary of Product characteristics

PAGE 1 OF 8
METASTRON
TM PRODUCT INFORMATION
PRODUCT INFORMATION
METASTRON
TM (STRONTIUM [
89
SR] CHLORIDE) INJECTION
Sterile Aqueous Injection 150MBq/vial
PRODUCT DESCRIPTION
A sterile aqueous solution of Strontium [
89
Sr] Chloride for intravenous injection.
Each vial contains 43.6-90.4 mg of Strontium Chloride (10.9-22.6mg per
millilitre).
The radioactive concentration is 37 MBq/ml (total 150 MBq per vial).
The specific activity is 2.96-6.17 MBq/mgSr.
The pH of the solution is 4-7.5.
The injection is sterilised by autoclaving and it contains no
bactericide.
The reference date, lot number, volume, radioactive concentration and
total radioactive
content for each batch are stated on the container labels.
The activities quoted are to the activity reference date stated on the
label.
PHARMACOLOGY
The behaviour of strontium in healthy man has been studied under the
auspices of the
International Committee for Radiation Protection (IRCP).
Strontium imitates calcium _IN VIVO_, and therefore localises in bone
mineral, especially at
sites of increased bone deposition. Strontium is not thought to
concentrate in lytic bone
lesions. In normal subjects 82% of an administered dose is initially
distributed in the
soft tissues and is removed with a half-life of about 2 days. However,
approximately
15% is retained in the soft tissues for a much longer period.
The strontium initially lost from soft tissue is partly excreted and
partly taken up by the
skeleton, which reaches a maximum content of 25% of the administered
strontium.
The behaviour of intravenous strontium in patients with bone
metastases has been
studied using strontium-85, a radioactive tracer with a gamma emission
convenient for
measurement. This study showed that sclerotic metastatic bone lesions
accumulated
strontium more than did normal bone. It was also observed that the
biological half-life
of strontium in the lesions was long compared to the 50.5 day physical
half-life of
strontium-89, whilst normal trabecular bone turned over strontium with
its usual initial
h