VISIPAQUE 320 mg I/ml Solution for Injection, glass container

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Iodixanol

Disponible depuis:

GE Healthcare AS

Code ATC:

V08AB; V08AB09

DCI (Dénomination commune internationale):

Iodixanol

Dosage:

320 mg I/mg millilitre(s)

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

Product subject to Restricted Prescription (C)

Domaine thérapeutique:

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

Statut de autorisation:

Marketed

Date de l'autorisation:

1995-09-19

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
VISIPAQUE 270 MG I/ML SOLUTION FOR INJECTION GLASS CONTAINER
VISIPAQUE 320 MG I/ML SOLUTION FOR INJECTION GLASS CONTAINER
VISIPAQUE 270 MG I/ML SOLUTION FOR INJECTION POLYPROPYLENE CONTAINER
VISIPAQUE 320 MG I/ML SOLUTION FOR INJECTION POLYPROPYLENE CONTAINER
iodixanol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor if you need more information or advice.
•
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 Visipaque is and what it is used for
2. What you need to know before you use Visipaque
3. How to use Visipaque
4. Possible side effects
5. How to store Visipaque
6. Contents of the pack and other information
1. WHAT VISIPAQUE IS AND WHAT IT IS USED FOR
Visipaque is a “contrast agent” for diagnostic use in adults and
children. It is used only to help
identify an illness and not in connection with treatment.
•
Once injected, it can help your doctor tell apart normal or abnormal
appearance and shape of
some organs in your body.
•
You can have Visipaque before examination of your urinary system,
joints, ovarian tubes,
spinal cord, blood vessels, including blood vessels of your heart and
the gullet, stomach and
the intestine.
•
This medicine can also be given to you before or during a scan of your
head or body using
“computed tomography” (CT-scan).
Your doctor might give you Visipaque for something else. Ask your
doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VISIPAQUE
DO NOT USE VISIPAQUE:
•
If you suffer from severe thyroid gland problems.
•
If you are allergic (hypersensitive) to iodixanol or any of the other
ingredients of Visipaque
(listed in section 6).
•
If you have acute pelvic inflammatory disease you should not have
X-ray examination of your
uterus and ovarian tubes.
If you are uncert

Résumé des caractéristiques du produit

HealthProductsRegulatoryAuthority
20October2023
CRN00DQVN
Page1of11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VISIPAQUE320mgI/mlSolutionforInjection,glasscontainer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Activeingredient
Strength
Contentpr.ml.
Iodixanol(INN)
270mgI/ml
550mgequiv.270mgI
Iodixanol(INN)
320mgI/ml
652mgequiv.320mgI
Iodixanolisanon‐ionic,dimeric,hexaiodinated,water‐solubleX‐raycontrastmedium.Pureaqueoussolutionsofiodixanolin
allclinicalrelevantconcentrationshavealowerosmolalitythanwholebloodandthecorrespondingstrengthsofthenon‐ionic
monomericcontrastmedia.VISIPAQUEismadeisotonicwithnormalbodyfluidsbyadditionofelectrolytes.Theosmolalityand
viscosityvaluesofVISIPAQUEareasfollows:
Concentration
Osmolality*
mOsm/kgH2O
37°C
Viscosity(mPas)
​
​
​
20°C
37°C
270mgI/ml
290
11.3
5.8
320mgI/ml
290
25.4
11.4
*Method:Vapour‐pressureosmometry.
ThepHoftheproductis6.8‐7.6.
270mgI/ml:Thismedicinalproductcontains0.76mg(0.03mmol)sodiumperml.Tobetakenintoconsiderationbypatients
onacontrolledsodiumdiet.
320mgI/ml:Thismedicinalproductcontains0.45mg(0.02mmol)sodiumperml.Tobetakenintoconsiderationbypatients
onacontrolledsodiumdiet(SEESECTION4.4).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Solutionforinjection.
VISIPAQUEissuppliedreadytouseasclear,colourlesstopaleyellowaqueoussolutions.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thismedicinalproductisfordiagnosticuseonly.
X‐rayco