ISOVUE 370 151.04g/200mL injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

iopamidol, Quantity: 755.3 mg/mL (Equivalent: iodine, Qty 370 mg/mL)

Tillgänglig från:

Bracco Pty Ltd

Läkemedelsform:

Injection, solution

Sammansättning:

Excipient Ingredients: water for injections; sodium calcium edetate; hydrochloric acid; trometamol

Administreringssätt:

Intravenous, Intraarterial

Enheter i paketet:

200mL X 1

Receptbelagda typ:

Not scheduled. Not considered by committee

Terapeutiska indikationer:

In adults, Isovue is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, peripheral venography (phlebography), coronary arteriography and ventriculography, selective visceral arteriography and aortography, intravenous excretory urography and contrast enhancement of computed tomographic head and body imaging. Isovue is also indicated for myelography (lumbar, total columnar) and for contrast enhancement in computed tomography of the central nervous system. In children, Isovue is indicated for intravascular use only, including intravenous excretory urography.

Produktsammanfattning:

Visual Identification: Clear colourless liquid; Container Type: Vial; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

1993-12-06

Bipacksedel

ISOVUE®
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers common questions about ISOVUE®.
It does not contain all the available information.
It does not take the place of talking to your radiologist (the
specialist doctor who does X‐rays), doctor or
pharmacist. All preparations of this type have risks and benefits.
Your radiologist and/or your doctor have
weighed the risks of your receiving ISOVUE® against the benefits they
expect it will have for you.
If you have any concerns about being given this preparation, ask your
radiologist, doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT IS ISOVUE®
ISOVUE® is the trade name for iopamidol, an iodine‐containing dye,
called a “contrast medium”. It comes
as a solution for injection in ampoules or vials.
WHAT ISOVUE® IS USED FOR AND HOW IT WORKS
ISOVUE® is used for making blood vessels and other parts of the body
visible to X‐rays.
Injection of ISOVUE® into the blood vessels dyes the blood vessels
through which the blood flows. This
allows the blood vessels in that area to be seen on an X‐ray.
Injection of ISOVUE® into the spinal cord allows the nerves within
the spine to be seen on an X‐ray. The
resulting X‐ray photographs may help your doctor to diagnose your
illness or problem.
In children, Isovue® is injected only into the blood vessels.
BEFORE YOU HAVE AN INJECTION OF ISOVUE®
_YOU MUST NOT HAVE AN INJECTION OF _ISOVUE®:
•If you are ALLERGIC TO IOPAMIDOL OR TO ANY OF THE INGREDIENTS IN
ISOVUE® (listed under “PRODUCT
DESCRIPTION, WHAT IT LOOKS LIKE”, at the end of this leaflet) or to
any other iodine‐containing contrast
media.
There have been some cases of severe and life‐threatening reactions
occurring with iodine‐containing
contrast media. The possibility of such reactions occurring with
ISOVUE® therefore cannot be ruled out.
Your radiologist has appropriate medicines and equipment on hand to
treat you, in the unlikely event that
you should experience a reaction to ISOVUE®.

Produktens egenskaper

AUSTRALIAN PRODUCT INFORMATION –
ISOVUE
® 300 (IOPAMIDOL) AND ISOVUE
® 370 (IOPAMIDOL)
1 NAME OF THE MEDICINE
Iopamidol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isovue
®
300 (lopamidol Injection 61%) provides 612mg iopamidol.
Isovue
®
370 (lopamidol Injection 76%) provides 755 mg iopamidol.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Injection, solution. Clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults, Isovue
®
is indicated for angiography throughout the cardiovascular system,
including
cerebral and peripheral arteriography, peripheral venography
(phlebography), coronary arteriography
and ventriculography, selective visceral arteriography and
aortography, intravenous excretory
urography and contrast enhancement of computed tomographic head and
body imaging.
Isovue
®
is also indicated for myelography (lumbar, total columnar) and for
contrast enhancement in
computed tomography of the central nervous system.
In children, Isovue
®
is indicated for intravascular use only, including intravenous
excretory
urography.
4.2 DOSE AND METHOD OF ADMINISTRATION
Depending on age, weight, cardiac output, general state of health, the
clinical problem, examination
technique, kind and volume of the region to be examined, an
appropriate dose should be used.
Examinations of infants and children always require individualisation
of dosages, to be chosen in the
first place in relation to the region to be demonstrated, the weight
and the age.
It is desirable that solutions of radiopaque diagnostic agents for
intrathecal or intravascular use be at
body temperature when injected. Isovue
®
solutions should be used only if clear and within the normal
colourless to pale yellow range. In the event that crystallisation of
the medium has occurred, the
solution should not be used. Many radiopaque contrast agents are
incompatible in vitro with some
antihistamines and many other drugs; therefore, no other
pharmaceuticals should be admixed with
contrast a