OMNISCAN gadodiamide 4.305g/15mL injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

gadodiamide, Quantity: 287 mg/mL

Tilgjengelig fra:

GE Healthcare Australia Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: water for injections; caldiamide sodium hydrate; hydrochloric acid; sodium hydroxide

Administreringsrute:

Intravenous

Enheter i pakken:

1 X 15mL

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Other conditions: Do not freeze. Omniscan is indicated for use in adults and children from 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood brain barrier or abnormal vascularity. INDICATIONS AS AT 10 DECEMBER 1999: Omniscan is indicated for use in adults and children from 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity and whole body imaging. INDICATIONS AS AT 25 JUNE 2003: OMNISCAN is indicated for: 1) use in adults and children, including infants and neonates less than 6 months of age for the enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity, and; 2) whole body imaging for adults and children over 6 months of age.

Produkt oppsummering:

Visual Identification: Clear, colourless to slightly yellow, particulate-free solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1993-12-16

Informasjon til brukeren

AUSTRALIA CMI
PAGE 1 OF 6
OMNISCAN™ CONSUMER MEDICINE INFORMATION AMENDED MARCH 2007
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet tells you about OMNISCAN™. The information in this
leaflet applies only
to OMNISCAN.
This leaflet answers some common questions about OMNISCAN. It does not
contain
all the available information about the product and is not intended to
replace discussions
you may wish to have with your doctor, radiologist or other health
professional.
All medicines have risks and benefits. Your doctors have weighed the
risks of you
being given this medicine against the benefits they expect it will
have for you.
PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN OMNISCAN.
IF YOU HAVE ANY QUESTIONS, ARE NOT SURE ABOUT ANYTHING OR IF YOU HAVE
ANY CONCERNS
ABOUT BEING GIVEN THIS MEDICINE - ASK YOUR DOCTOR, RADIOGRAPHER OR
NURSE.
KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN.
WHAT OMNISCAN IS USED FOR
OMNISCAN is one of a group of medicines known as ‹contrast media›
which are used
in Magnetic Resonance Imaging (MRI) examinations.
OMNISCAN is used in MRI examinations of the brain or spine, as well as
other parts of
the body. OMNISCAN makes it easier to detect and locate changes and to
improve the
diagnostic information your radiologist needs.
OMNISCAN is intended for use in hospitals and radiology clinics only.
OMNISCAN is for use in adults, children and babies over 4 weeks of
age.
HOW OMNISCAN WORKS
MRI uses the magnetic properties of molecules in the body to “see”
organs and other
structures in the body and how they may have changed as a result of
any condition you
may have. OMNISCAN can greatly improve the clarity of the images the
radiologist
looks at to enable better, and more accurate, diagnosis of your
condition.
AUSTRALIA CMI
PAGE 2 OF 6
OMNISCAN™ CONSUMER MEDICINE INFORMATION AMENDED MARCH 2007
WHAT IS IN OMNISCAN
The name of your medicine is OMNISCAN. It contains an active substance
known as
gadodiamide.
OMNISCAN is a sterile, aqueous solution for injection, and con

Preparatomtale

OMNISCAN
TM PRODUCT INFORMATION
80307
AUSTRALIA PI
PAGE 1 OF 17
AUSTRALIAN PRODUCT
INFORMATION
1.
NAME OF MEDICINE
GADODIAMIDE
2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Sterile Aqueous Injection 287 mg/mL
OMNISCAN (gadodiamide) injection is the formulation of the gadolinium
complex of
diethylenetriamine pentaacetic acid bismethylamide, and is an
injectable, non-ionic,
linear, paramagnetic, extracellular enhancing agent for magnetic
resonance imaging.
OMNISCAN is to be administered by intravenous injection. OMNISCAN is
provided as a
sterile, clear, and colourless to slightly yellow aqueous solution.
Each mL contains 287
mg gadodiamide, 12 mg caldiamide sodium and water for injection. The
pH is adjusted
between 6.0 and 7.0 with hydrochloric acid or sodium hydroxide.
OMNISCAN contains
no antimicrobial preservative.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OMNISCAN is indicated for:
1)
use in adults and children, including infants and neonates less than 6
months of
age for the enhancement of magnetic resonance images of intracranial
and
spinal lesions where there is an abnormal blood-brain barrier or
abnormal
vascularity, and;
2)
whole body imaging for adults and children over 6 months of age.
AUSTRALIA PI
PAGE 2 OF 18
OMNISCAN
TM PRODUCT INFORMATION
80307
4.2 DOSE AND METHOD OF ADMINISTRATION
Gadolinium containing contrast agents (GdCAs) should be used only when
diagnostic
information is essential and not available with unenhanced magnetic
resonance imaging
(MRI).
No special preparation of the patient is required. OMNISCAN should be
drawn into the
syringe immediately before use. For use in single patient only and any
unused portion
must be discarded. For intravenous use. The required dose should be
administered as a
single intravenous injection. To ensure complete injection of the
contrast medium, the
injection should be followed by a 5 mL, sodium chloride 0.9% (normal
saline flush).
Unless otherwise specified, the imaging procedure should be completed
within 1 hour
of admi