Omnipaque 240 iohexol 25.9g/50mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

iohexol, Quantity: 518 mg/mL (Equivalent: iodine, Qty 240 mg/mL)

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intraarterial, Oral

Units in package:

50 mLx10, 50mL x 1

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 12 NOVEMBER 2003: Intravascular: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography. Oral/Body Cavities: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography and in adults, children and premature babies for studies of the gastrointestinal tract.

Product summary:

Visual Identification: Clear, colourless to pale yellow slightly viscous liquid; Container Type: Ampoule; Container Material: PP; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-10-31

Patient Information leaflet

Omnipaque™ CMI
Page 1 of 5
CONSUMER PRODUCT INFORMATION
OMNIPAQUE™ INJECTION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about OMNIPAQUE. 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 you
receiving OMNIPAQUE 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 OMNIPAQUE IS USED FOR
OMNIPAQUE is one of a group of medicines known as “contrast media”
for diagnostic use. OMNIPAQUE is used in X-
ray examinations in many different parts of the body for adults and
children. It can make it easier to find and see
abnormalities, and improves the diagnostic information needed by the
doctor.
BEFORE YOU ARE GIVEN OMNIPAQUE
WHEN YOU MUST NOT BE GIVEN IT.
OMNIPAQUE SHOULD NOT BE GIVEN TO YOU IF
:
1.
You have ever had or are allergic to OMNIPAQUE, to any of the
ingredients listed at the end of this leaflet (see
Product Description) or to any other contrast medium. Symptoms of an
allergic reaction may include
wheeziness, difficulty in breathing or tightness or pain in the chest,
skin rash, swelling or itching.
2.
You have thyroid gland problems.
3.
You have had recent heart disease or problems with your heart.
4.
The expiry date on the pack has passed. If you use it after the expiry
date, it may have no effect at all, or worse,
an entirely unexpected effect.
5.
You have an infection or open wound near the site to be examined.
6.
You are pregnant or intend to become pregnant. If you receive
Omnipaque whilst pregnant, your newborn should
be tested to ensure they are producing the correct amount of thyroid
hormone.
BEFORE YOU ARE GIVEN IT.
YOU MUST TELL YOUR DOCTOR IF:
1.
You are pregnant, intend to beco

Summary of Product characteristics

020507
OMNIPAQUE™ Product
Page 1 of 30
AUSTRALIAN PRODUCT INFORMATION
OMNIPAQUE
TM
(IOHEXOL) INJECTION FOR
INTRAVASCULAR, ORAL AND BODY CAVITIES AND INTRATHECAL USE
1. NAME OF THE MEDICINE
Iohexol
2 . QUALITATIVE AND QUANTITATIVE COMPOSITON
OMNIPAQUE 180 mgI/mL, 240 mgI/mL, 300 mgI/mL, 350 mg/mL Solution for
Injection
Active
ingredient
Strength
Content per mL
Iohexol (INN)
Iohexol (INN)
Iohexol (INN)
Iohexol (INN)
180 mg
I/ml
240 mg
I/ml
300 mg
I/ml
350 mg
I/ml
388 mg equiv. 180 mg I
518 mg equiv. 240 mg I
647 mg equiv. 300 mg I
755 mg equiv. 350 mg I
020507
OMNIPAQUE™ Product
Page 2 of 30
LIST OF EXCIPIENTS
For the full list of excipients, see Section 6.1 List of Excipients
3. PHARMACEUTICAL FORM
Omnipaque Solution for injection.
OMNIP AQ UE is supplied ready to use as clear, colourless to pale
yellow,
sterile aqueous
solutions.
OMNIPAQUE at a concentration of 140 mg I/mL is isotonic to blood.
OMNIPAQUE
contains no
preservative. Each vial or bottle should be used only once and any
residue
discarded.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
INTRAVASCULAR:
OMNIPAQUE is indicated in adults for angiography, excretory urography
and contrast enhancement
in
computerised tomography. In children, OMNIPAQUE is indicated for
angiography and
urography.
ORAL/BODY CAVITIES:
OMNIPAQUE is indicated in adults for arthrography, endoscopic
retrograde pancreatography (ERP),
endoscopic retrograde cholangiopancreatography (ERCP), herniography,
hysterosalpingography,
and
in adults, children and premature babies for studies of the
gastrointestinal tract.
INTRATHECAL:
OMNIPAQUE is indicated for lumbar, thoracic, cervical and total
columnar myelography and
in
computerised tomography of the CNS in adults and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
General
Administration of contrast media should be performed by qualified
personnel familiar with
the
procedure, and an appropriate technique should be utilised.
As in all diagnostic procedures, the lowest dose of OMNIPAQU