情報リーフレット
RADPHARM HDP
RADPHARM HDP kit for the preparation of Technetium [
99m
Tc]
Oxidronate injection
_Sodium Oxidronate _
_ _
Consumer Medicine Information_ _
RADPHARM
SCIENTIFIC
CMI 08.11
1
_What is in this Leaflet _
This leaflet answers some common questions about
RADPHARM HDP. It does not contain all of the
available information and does not take the place of
talking to your doctor or nuclear medicine specialist.
All medicines, including diagnostic agents, have risks
and benefits. Your referring doctor, in consultation
with the nuclear medicine specialist, has weighed the
risks of giving you RADPHARM HDP injection,
against the benefits they expect the procedure will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN
RADPHARM HDP, DISCUSS WITH YOUR DOCTOR
AND/OR NUCLEAR MEDICINE SPECIALIST.
KEEP THIS LEAFLET AS YOU MAY NEED TO REFER TO IT
AGAIN.
_ _
_What is RADPHARM HDP _
RADPHARM HDP belongs to a group of medicines
called radiopharmaceuticals.
RADPHARM HDP
is only available through a doctor’s
prescription.
RADPHARM HDP contains the active ingredient,
sodium oxidronate and is reconstituted with sodium
pertechnetate (
99m
Tc) prior to injection. Once
reconstituted, the product becomes radioactive.
_ _
_What RADPHARM HDP is used for _
RADPHARM HDP is used in conjunction with an
imaging agent to detect alterations of the skeletal
system in adults.
The imaging agent used is a radiotracer called
Technetium-99m.
完全なドキュメントを読む
製品の特徴
_RADPHARM HDP sodium oxidronate 3.15mg kit for
the preparation of technetium (_
_99m_
_Tc) oxidronate for injection _
_ _
__AUST R 160732 _
_ _
_PRODUCT INFORMATION SHEET _
_________________________________________________________
_
Page 1 of 6
NAME OF THE MEDICINE
PROPRIETARY NAME
RADPHARM HDP kit for the preparation of
Technetium [
99m
Tc] Oxidronate Injection
NON-PROPRIETARY NAME
Sodium Oxidronate
CHEMICAL NAME
Hydroxymethylenediphosphonate disodium
salt (HDP)
MOLECULAR FORMULA
CH
4
Na
2
O
7
P
2
MOLECULAR WEIGHT
235.97
CAS NUMBER
14255-61-9
CHEMICAL STRUCTURE
P
P
HO
H
O
HO
ONa
O
OH
NaO
Chemical Formula: CH
4
Na
2
O
7
P
2
Molecular Weight: 235.97
Elemental Analysis: C, 5.09; H, 1.71; Na,
19.49; O, 47.46; P, 26.25
DESCRIPTION
RADPHARM HDP is supplied as sterile,
pyrogen free, lyophilised powder, vacuum
sealed in borosilicate Type 1 glass 10mL vial
for
intravenous
injection
following
reconstitution with non-pyrogenic
99m
Tc as
pertechnetate sodium (
99m
TcO
4
-
).
The reconstituted product is a clear, colourless
liquid.
Each 10mL tinted vial contains:
Sodium oxidronate 3.15mg as an active
ingredient; Stannous chloride dihydrate
0.297mg, gentisic 0.84mg and sodium chloride
29mg as excipients.
RADPHARM HDP contains no antimicrobial
preservatives.
PHYSICAL CHARACTERISTICS OF TECHNETIUM-99M
Technetium 99m, with a physical half life of 6
hours, decays by isomeric transition to
technetium-99. Photons associated with this
transition that are useful for detection and
imaging studies are listed in the tables below,
followed by the physical decay chart for
Technetium-99m
1
.
_Table 1: Principal Radiation Emission Data _
Prin
完全なドキュメントを読む