DRAXIMAGE MACROSALB kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection vial

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

aggregated albumin, Quantity: 2.5 mg

Pieejams no:

Jubilant Pharma Australia Pty Ltd

Zāļu forma:

Injection, powder for

Kompozīcija:

Excipient Ingredients: stannous chloride dihydrate; sodium chloride; Albumin

Ievadīšanas:

Intravenous, Intraperitoneal

Vienības iepakojumā:

box of 10 vials

Receptes veids:

Not scheduled. Not considered by committee

Ārstēšanas norādes:

Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.

Produktu pārskats:

Visual Identification: powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store between 2 - 25 degrees celsius

Autorizācija statuss:

Registered

Autorizācija datums:

2020-04-23

Lietošanas instrukcija

DRAXIMAGE MACROSALB
®
_Kit for the Preparation of Technetium [_
_99m_
_Tc] Albumin Aggregated Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions
about
DRAXIMAGE
MACROSALB
®
.
It
does
not
contain
all
the
available
information, nor does it take the
place of talking to your doctor
or treatment provider.
All
medicines
and
diagnostic
preparations
have
risks
and
benefits.
Your
doctor
has
weighed
the
risks
of
you
receiving
DRAXIMAGE
MACROSALB
®
against
the
expected benefits.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
DRAXIMAGE
MACROSALB
®
,
ASK
YOUR
DOCTOR OR TREATMENT PROVIDER.
KEEP
THIS
LEAFLET.
You
may
need to refer to it again.
WHAT
DRAXIMAGE
MACROSALB
®
IS
USED
FOR
DRAXIMAGE MACROSALB
®
is for diagnostic use only.
It is used in the preparation of a
radiopharmaceutical, which is a
medicinal product containing a
small amount of radioactivity.
Such
radiopharmaceuticals
are
given in small amounts to find
or
rule
out
a
disease.
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
or
just
passes through your body. The
radiation is captured by a special
camera
and
pictures
are
prepared. These pictures allow
the nuclear medicine doctor to
detect any problems.
DRAXIMAGE MACROSALB
®
can
be
used
for
lung
scans.
These scans provide information
about the structure of the lungs
and the blood flow through the
lung tissue.
DRAXIMAGE MACROSALB
®
can also be used to show how
the
blood
flows
through
the
veins.
Your doctor will tell you which
specific
investigation
DRAXIMAGE MACROSALB
®
will be used for in your case.
BEFORE
YOU
ARE
GIVEN
DRAXIMAGE
MACROSALB
®
_ _
_WHEN YOU MUST NOT BE GIVEN _
_DRAXIMAGE MACROSALB®_
Do
not
use
DRAXIMAGE
MACROSALB
®
if
you
are
allergic
(hypersensitive)
to
macroaggregated albumin or any
of
the
ingredients
of
DRAXIMAGE MACROSALB
®
listed at the end of this leaflet, or
if
you have
severe
pulmonary
hypertension
(unusually
high
blood pr

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION -
DRAXIMAGE MACROSALB
®
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED
INJECTION
1
NAME OF THE MEDICINE
Albumin Aggregated
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The
kit
consists
of
reaction
vials
which
contain
the
sterile,
non-pyrogenic,
non-
radioactive ingredients necessary to produce Technetium Tc 99m Albumin
Aggregated
Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5 mg
of albumin, 0.06
mg (minimum) stannous chloride (maximum stannous and stannic chloride
0.11 mg) and
1.2 mg of sodium chloride; the contents are in a lyophilized form
under an atmosphere of
nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH
adjustment. No
bacteriostatic preservative is present.
The albumin was non-reactive when tested for Hepatitis B Surface
Antigen (HB
s
Ag),
antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2), antibody to
Hepatitis C
Virus
(anti-HCV)
and
Antigen
to
Human
Immunodeficiency
Virus
(HIV-1).
The
aggregated
particles
are
formed
by
denaturation
of
the
albumin
in
a
heating
and
aggregation process. Each vial contains 3 to 8 million particles. By
light microscopy,
more than 90% of the particles are between 10 and 70 micrometers,
while the typical
average size is 20 to 40 micrometers; none is greater than 150
micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is
in its final
dosage form when a sterile isotonic sodium pertechnetate solution is
added to the vial
(The radioisotope is not part of the kit). No less than 90% of the
pertechnetate Tc-99m
added to a reaction vial is bound to aggregate at preparation time and
remains bound
throughout the usage lifetime of the preparation (See Directions for
Preparation under
_Section 4.2 DOSE AND METHOD OF ADMINISTRATION_
).
3
PHARMACEUTICAL FORM
Kit
for
the
Preparation
of
Technetium
Tc
99m
Albumin
Aggregated
Injection
-
DIAGNOSTIC - For Intravenous and Intraperitoneal Use.
4
CLINICAL PARTICULARS
_4.1_
_ _