RADPHARM HDP sodium oxidronate 3.15 mg kit for the preparation of technetium (99m Tc) oxidronate for injection

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

sodium oxidronate, Quantity: 3.15 mg

Dostupno od:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

INN (International ime):

sodium oxidronate

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients: sodium chloride; stannous chloride dihydrate; dilute hydrochloric acid; gentisic acid; sodium hydroxide

Administracija rute:

Intravenous

Jedinice u paketu:

30 x 10 mL vials, 10 x 10 mL vials

Tip recepta:

Not scheduled. Not considered by committee

Terapijske indikacije:

Technetium [99m Tc] Sodium Oxidronate is a diagnostic skeletal imaging agent to demonstrate areas of altered osteogenesis in adult patients.

Proizvod sažetak:

Visual Identification: fine white powder in glass vials; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2011-08-15

Uputa o lijeku

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.
Technetium-99m
emits
small
amounts of radiation similar to x-rays which can be
detected by a special camera (gamma camera) to
produce an image known as a scan. A nuclear
medicine
specialist
interprets
these
scans
and
provides information related to your referral.
Your nuclear medicine specialist may be giving you
RADPHARM HDP to help diagnose other conditions.
Ask your nuclear medicine specialist if you have any
questions
about
why
RADPHARM
HDP
is
being
given to you and why you have been referred for a
scan.
_ _
_Before receiving RADPHARM HDP _
Tell your nuclear medicine specialist or technologist
if;
1

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – RADPHARM HDP SODIUM
OXIDRONATE 3.15 MG KIT FOR THE PREPARATION OF TECHNETIUM
(99M TC) OXIDRONATE FOR INJECTION (SODIUM OXIDRONATE)
1
NAME OF THE MEDICINE
sodium oxidronate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Radpharm HDP is supplied as sterile, pyrogen free, lyophilised powder,
under nitrogen in borosilicate
Type 1 glass 10mL vial for intravenous injection following
reconstitution with non-pyrogenic 99mTc
as pertechnetate sodium (99mTcO4-).
Each 10mL tinted vial contains: Sodium oxidronate 3.15mg as an active
ingredient; Stannous chloride
dihydrate 0.297mg, Gentisic acid 0.84mg and Sodium chloride 29mg as
excipients.
The reconstituted product is a clear, colourless liquid.
Radpharm HDP contains no antimicrobial preservatives
3
PHARMACEUTICAL FORM
Fine white powder in glass vials.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Technetium [99mTc] Sodium Oxidronate may be used as a skeletal imaging
agent to delineate areas
of altered osteogenesis in adult patients.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULT:
The recommended intravenous dose of Technetium [99mTc] Sodium
Oxidronate for the average
adult patient (70kg) is 555MBq, with a minimum administered activity
of 370MBq and maximum
administered activity is 740MBq. The administered dose of Sodium
Oxidronate should not exceed
0.05mg/kg.
GENERAL INSTRUCTIONS
:
The administered dose of Sodium Oxidronate is between 0.001-0.05mg/kg.
The ideal administered
dose of Sodium Oxidronate is 0.005mg/kg. The radioactivity of each
dose should be measured by an
appropriate radiation calibration system immediately prior to
administration. The dose should be
administered intravenously by slow injection. For optimal results bone
imaging should be performed
1-4 hours post-injection.
2
RADIATION DOSIMETRY
The estimated absorbed radiation doses and effective doses from an
intravenous administration of
Technetium [99mTc] Sodium Oxidronate are presented in Table 1
.
Table 1: Estimated absorbed radiation dose per unit administered
activit