Omnipaque injection 300mg I/ml

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

IOHEXOL

Disponible depuis:

GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway

Code ATC:

V08AB02

DCI (Dénomination commune internationale):

IOHEXOL 300 mg I/ml

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

IOHEXOL 300 mg I/ml

Type d'ordonnance:

POM

Domaine thérapeutique:

CONTRAST MEDIA

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-09-20

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
•
Some other people are given this medicine before or during a scan of
their 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.
Your doctor will explain which part of your body will be scanned.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OMNIPAQUE
DO NOT USE OMNIPAQUE:
•
If you suffer from severe thyroid problems
•
If you are allergic (hypersensiti

Résumé des caractéristiques du produit

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OMNIPAQUE injection, 300 mg I/ml, 350 mg I/ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Strength
Content per. ml.
Iohexol (INN) Iohexol
(INN)
300 mg I/ml
350 mg I/ml
647 mg equiv. 300 mg I
755 mg equiv. 350 mg I
Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray
contrast medium.
The osmolality and viscosity values of Omnipaque are as follows:
Concentration
Osmolality *
Osm/kg H2O
37°C
20°C
37°C
300 mg I/ml
350 mg I/ml
0.64
0.78
11.6
23.3
6.1
10.6
* 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. Omnipaque injection is supplied ready to use
as clear, colourless to
pale yellow, sterile aqueous 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
cardioangiography,
arteriography, urography, phlebography and CT-enhancement. Cervical
myelography,
following subarachnoid injection. Arthrography, hysterosalpingography,
sialography and
studies of the gastrointestinal tract.
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
Page 2 of 18
contrast media.
For intravenous, intra-arterial and intrathecal use, and use in body
cavities.
The following dosages may serve as a guide.
GUIDES FOR INTRAVENOUS USE
Indication
Concentration
Volume
Comments
UROGRAPHY
adults:
children < 7 kg
300 mg I/ml
or 350 mg I/ml
300 mg I/ml
40 - 80 ml
40 - 80 ml
3 ml/kg b.w.
80 ml may be
exceeded in
selected cases
children >