MYOVIEW kit for the preparation of technetium [99cm Tc] tetrofosmin injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tetrofosmin, Quantity: 0.23 mg; stannous chloride dihydrate, Quantity: 0.03 mg

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium bicarbonate; sodium gluconate; disodium sulfosalicylate

Administration route:

Intravenous

Units in package:

2 vials, 5 vials

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Myoview is indicated as an adjunct in the diagnosis of ischaemic heart disease infarction.

Product summary:

Visual Identification: White, powdery solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 52 Weeks; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1997-08-26

Patient Information leaflet

MYOVIEW™
_For preparation of Technetium [_
_99m_
_Tc] Tetrofosmin Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MYOVIEW. It does
not contain all the available
information, nor does it take the place
of talking to your doctor or pharmacist.
All medicines and diagnostic
preparations have risks and benefits.
Your doctor has weighed the risks of
you being treated with MYOVIEW
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST OR TREATMENT PROVIDER.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MYOVIEW IS USED
FOR
MYOVIEW is used in the preparation
of Technetium [
99m
Tc] Tetrofosmin
Injection, a radioactive medicinal
product. Such substances are also
known as radiopharmaceuticals.
Such radiopharmaceuticals are given in
small amounts to find or rule out a
disease. When used in this way the
radiation your body receives is very
low and is considered safe.
After the radioactive liquid is given to
you, it is taken up by the organs of
interest, especially the heart muscle or
just passes through your body. The
radiation is taken up by a special
camera and pictures are prepared.
These pictures allow the nuclear
medicine doctor to detect any
problems.
MYOVIEW is used to help detect areas
in the heart that may not be getting
enough blood to work properly.
MYOVIEW is used as an aid in
diagnosis only. It is not used to treat or
cure the condition.
BEFORE YOU ARE GIVEN
MYOVIEW
_WHEN YOU MUST NOT BE GIVEN _
_IT _
_ _
MYOVIEW is not recommended for
adolescents or children under 12 years
of age.
You must not be given MYOVIEW if
you are allergic to it or any of the
ingredients listed at the end of this
leaflet or have had an allergic reaction
in a diagnostic procedure with the same
or a similar preparation.
You must not be given MYOVIEW if
you are pregnant.
_BEFORE YOU ARE GIVEN IT _
YOUR DOCTOR MUST KNOW ABOUT ALL OF
THE FOLLOWING BEFORE YOU ARE GIVEN
MYOVIEW. TELL YOUR DOCTOR IF YOU:
1.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION -MYOVIEW
KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] TETROFOSMIN INJECTION
1.
NAME OF THE MEDICINE
TETROFOSMIN
2. & 3. QUALITATIVE AND QUANTITATIVE
COMPOSITION AND PHARMACEUTICAL FORM
MYOVIEW
®
consists of a freeze-dried formulation contained within a 10mL,
neutral
glass vial and sealed with a chlorobutyl closure and an aluminium
overseal.
Each vial contains:
Tetrofosmin (active ingredient)
0.23mg
Stannous chloride dihydrate
0.03mg
Disodium sulphosalicylate
0.32mg
Sodium D-gluconate
1.0mg
Sodium bicarbonate
1.8mg
Nitrogen gas
to 80% atmospheric pressure
Nuclear Data for Technetium-99m
Sodium Pertechnetate [
99m
Tc] Injection Ph.Eur is produced by a [
99
Mo/
99
Tc] generator.
Technetium-99m disintegrates with the emission of gamma radiation
(energy 141keV,
88.5%; 43keV, 0.03%) and a half life of 6.02 hours).
To correct for the physical decay of this radionuclide, the fractions
that remain at
selected intervals relative to the time of calibration are shown in
the following Table:
TABLE 1
PHYSICAL DECAY CHART FOR
99M
TC
HOURS
FRACTION
REMAINING
HOURS
FRACTIONING
REMAINING
*
1.000
7
0.447
1
0.891
8
0.339
2
0.795
9
0.355
3
0.708
10
0.317
4
0.631
11
0.282
5
0.563
12
0.252
6
0.502
24
0.063
*
Calibration time (time of preparation)
The specific gamma ray constant for
99m
Tc is 0.19mGy per MBq-hour at 1cm. The first
half-value thickness of lead for
99m
Tc is 0.2mm. Attenuation by lead is given in the
following Table:
TABLE 2
RADIATION ATTENUATION BY LEAD SHIELDING
SHIELD THICKNESS Pb (mm)
COEFFICIENT OF ATTENUATION
0.2
0.5
0.95
10
-1
1.8
10
-2
2.7
10
-3
3.6
10
-4
4.5
10
-5
These data are useful for radiation protection purposes. The dose rate
at 0.5m from a
vial containing 1.11GBq technetium-99m will be reduced to less than
2.5

Sv/h by
shielding with 2mm lead.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYOVIEW® is indicated as an adjunct in the diagnosis of ischaemic
heart
disease
4.2 DOSAGE AND ADMINISTRATION
For the diagnosis and localization of myocardial ischaemia the
r