Omnipaque 300 mg I/ml Solution for Injection (Glass)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iohexol

Available from:

GE Healthcare AS

ATC code:

V08AB; V08AB02

INN (International Name):

Iohexol

Dosage:

300 milligram(s)

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Watersoluble, nephrotropic, low osmolar X-ray contrast media; iohexol

Authorization status:

Marketed

Authorization date:

1990-03-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMNIPAQUE 140 MG I/ML SOLUTION FOR INJECTION
OMNIPAQUE 180 MG I/ML SOLUTION FOR INJECTION
OMNIPAQUE 240 MG I/ML SOLUTION FOR INJECTION
OMNIPAQUE 300 MG I/ML SOLUTION FOR INJECTION
OMNIPAQUE 350 MG I/ML SOLUTION FOR INJECTION
Iohexol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING OMNIPAQUE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Omnipaque is and what it is used for
2.
What you need to know before you use Omnipaque
3.
How to use Omnipaque
4.
Possible side effects
5.
How to store Omnipaque
6.
Contents of the pack and other information
1. WHAT OMNIPAQUE IS AND WHAT IT IS USED FOR
Omnipaque contains the active substance iohexol. This medicine is for
diagnostic use only. It is used
only to help identify an illness and not in connection with treatment.
Omnipaque is a ‘contrast medium’. It is given before an X-ray to
make the picture that your doctor
takes clearer.
•
Once injected, it can help your doctor tell apart normal or abnormal
appearance and shape of
some organs in your body.
•
It can be used for X-rays of your urinary system, spine or blood
vessels, including blood vessels
of your heart.
•
You may be given this medicine before or during a scan of your head or
body using ‘computed
tomography’ (also called a CAT scan). This type of scan uses X-rays.
•
It can also be used to look at your salivary glands, stomach and
intestine, or for looking in body
cavities, such as in your joints or womb and ovarian tubes.
•
It can also be used in cases of mammography examinations.
Your doctor will explain which part of y

Summary of Product characteristics

Health Products Regulatory Authority
12 March 2024
CRN00DLK2
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omnipaque 300 mg I/ml Solution for Injection (Glass)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iohexol 647 mg/ml equivalent to 300mg/ml Iodine.
Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray
contrast medium.
The osmolality and viscosity values of Omnipaque 300 mg I/ml are as
follows:
Concentration
Osmolality *
Osm/kg H2O
Viscosity
(mPa×s)
37°C
20°C
37°C
300 mg I/ml
0.64
11.6
6.1
* Method: Vapour - pressure osmometry.
This medicinal product contains 0.012mg sodium per ml, i.e.
essentially sodium free.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X-ray contrast medium for use in adults and children for angiography,
urography, phlebography and CT-enhancement.
Lumbar, thoracic, cervical myelography and computed tomography of the
basal cisterns, following subarachnoid injection.
Arthrography, endoscopic retrograde pancreatography (ERP), endoscopic
retrograde cholangiopancreatography (ERCP),
herniography, hysterosalpingography, sialography and studies of the
gastrointestinal tract. Contrast-enhanced mammography
(CEM) in adults to evaluate and detect known or suspected lesions of
the breast, as an adjunct to mammography (with or
without ultrasound) or as an alternative to magnetic resonance imaging
(MRI) when MRI is contraindicated or unavailable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage varies depending on the type of examination, age, weight,
cardiac output and general condition of the patient and
the technique used. Usually the same iodine concentration and volume
is used as with other iodinated X-ray contrast media in
current use. Adequate hydration should be assured before and after
administration as for other contrast media.
For intrave