LEUKOSCAN sulesomab 0.31mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Sulesomab, Quantity: 0.31 mg

זמין מ:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (שם בינלאומי):

Sulesomab

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: glacial acetic acid; stannous chloride dihydrate; sodium acetate trihydrate; sodium chloride; sucrose; potassium sodium tartrate tetrahydrate; hydrochloric acid

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

Single unit pack

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Use in diagnostic imaging for the investigation of suspected osteomyelitis in long bones and in feet in patients including those with diabetic foot ulcers.

leaflet_short:

Visual Identification: Colourless Solution when reconstituted.; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2002-03-20

עלון מידע

LEUKOSCAN
® SULESOMAB
1
CONSUMER MEDICINE INFORMATION
LEUKOSCAN
® SULESOMAB
KIT FOR THE PREPARATION OF TECHNETIUM -99M LABELLED LEUKOSCAN
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about LeukoScan. It does
not contain all the
available information, nor does it take the place of you talking to
your nuclear medicine specialist
or physician.
All medicines and diagnostic agents have risks and benefits associated
with their use. Your
nuclear medicine specialist has weighed the risks of you being treated
with LeukoScan against the
benefits it is expected you will receive.
KEEP THIS LEAFLET. You may need to read it again.
NAME OF YOUR MEDICINE
LeukoScan is the trade name of your medicine. Sulesomab is the common
name.
PRODUCT DESCRIPTION
Each 3-ml vial (glass container) contains 0.31mg of active substance,
sulesomab, as a powder for
solution for injection. The other ingredients are stannous chloride,
sodium chloride, sodium
potassium tartrate, sodium acetate and sucrose.
WHAT LEUKOSCAN IS AND WHAT IT IS USED FOR
An antibody is a natural substance made by the body which binds
foreign substances to help
remove them from your body. You produce many difference kinds on
antibodies. LeukoScan
Sulesomab is a special kind of antibody which binds to the surface of
certain kinds of blood cells
called leukocytes. It is produced in mice and purified so that if can
be used in humans. When it is
combined to the radioactive technetium isotope and injected, it finds
an abnormal accumulation
of white blood cells and attaches to them. This helps your doctor make
a diagnosis and evaluate
the extent of your illness. The doctor does this by using a special
imaging camera that reveals
areas of radioactivity.
THERAPEUTIC GROUP:
HOW LEUKOSCAN WORKS.
LeukoScan is used to determine the present of infections in long
bones. Shortly after mixing the
LeukoScan with the radioactive technetium isotope, the doctor will
inject it into your vein. One
to eight hours later you will be placed on a special table and
pictures will be

מאפייני מוצר

_PI_
P
RODUCT
I
NFORMATION
Sterile, Non-pyrogenic,
Lyophilized Powder for Intravenous Use after Reconstitution with
Pertechnetate [
99m
Tc]
Radiodiagnostic Agent, Infectious Disease Imaging Agent
_PI_
P
RODUCT
I
NFORMATION
LEUKOSCAN
®
, SULESOMAB
KIT FOR THE PREPARATION OF TECHNETIUM-99M LABELLED LEUKOSCAN
Immunomedics, Inc.
300 American Road
Morris Plains, New Jersey 07950
United States of America
Distributed by
TGA Approval date: 5 March 2002
TGA Approval Date: 5th March 2002
AUST R: 82071
Product No: 10165
SUPPLIER
LeukoScan is supplied in Australia by:
LEUKOSCAN
®
, SULESOMAB
Locked Bag 2001
Kirrawee DC
NSW 2232
Amended format: February 2011
Date of printing:
30/3/2011
ANSTO Health
Locked Bag 2001
Kirrawee DC
NSW 2232
Telephone:
1800 251 572
Facsimile:
02 9543 6511
ANSTO Health is a commercial enterprise
of the Australian Nuclear Science and
Technology Organisation (ANSTO),
which is located at Lucas Heights,
in Sydney, N.S.W.
ANSTO Health
2.
Table 1
Summary of Normal organ Dosimetry
to an Average Adult Patient (70 kg) from
an Intravenous Dose of Technetium-99m
LeukoScan
[Dose estimate from 13 Subjects
26 Administrations]
AVERAGE DOSE
ORGAN
(ΜGY/MBQ)
Kidneys
Urinary Bladder Wall
Spleen
Heart Wall
Lungs
Liver
Bone Surfaces
Adrenals
Red Marrow
Pancreas
Thyroid
Gall Bladder Wall
Uterus
ovaries
Small Intestine
Stomach
Upper Large Intestinal Wall
Lower Large Intestinal Wall
Thymus
Total Body
Muscle
Testes
Breasts
Brain
Skin
effective Dose (µSv/MBq)
PRESENTATION
Package containing one (1) vial, with a
single-use dose of 0.31 mg lyophilized
sulesomab. The product should not be used
beyond the expiration date printed on the
label.
EXPIRY
The expiry date for this kit stored at 2°C-8°C
is 48 months from the day of manufacture.
STORAGE
Store at 2°C-8°C. Do not freeze.
To reduce microbiological hazard, use as
soon as practicable after reconstitution and
radiolabelling. If storage is necessary, hold at
2°C-8°C for not more than four hours.
Contains no antimicrobial agent. Use once
and discard any residue. Product