Lipiodol Ultra Fluid 38% w/w Solution for injection

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

organically combined iodine.

Tilgængelig fra:

Guerbet

ATC-kode:

V08AD

INN (International Name):

organically combined iodine.

Dosering:

38 percent weight/weight

Lægemiddelform:

Solution for injection

Recept type:

Product subject to Restricted Prescription (C)

Terapeutisk område:

Non-watersoluble X-ray contrast media

Autorisation status:

Marketed

Autorisation dato:

1996-05-07

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPIODOL ULTRA FLUID 38% W/W, SOLUTION FOR INJECTION
Iodised ethyl-esters of fatty acids of poppy seed oil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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.
WHAT IS IN THIS LEAFLET
:
1.
What Lipiodol Ultra Fluid is and what it is used for
2.
What you need to know before you use Lipiodol Ultra Fluid
3.
How to use Lipiodol Ultra Fluid
4.
Possible side effects
5.
How to store Lipiodol Ultra Fluid
6.
Contents of the pack and other information
1.
WHAT LIPIODOL ULTRA FLUID IS AND WHAT IT IS USED FOR
Lipiodol Ultra Fluid is a diagnostic agent. It belongs to the group of
contrast agents used for radiological
examinations.
Lipiodol Ultra Fluid is used to enhance the contrast of the images
obtained during radiological examinations.
This contrast enhancement improves the visualisation and outline of
certain body parts.
Lipiodol Ultra Fluid is used in radiological examinations of the
uterus and Fallopian tubes when searching
for causes of infertility.
When mixed with certain medicines used to treat liver cancer, Lipiodol
Ultra Fluid carries and delivers the
anti-cancer medicine into the area to be treated as part of a TACE
procedure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LIPIODOL ULTRA FLUID
You should read the information in this section carefully.
You and your doctor should take the information into consideration
before you are given Lipiodol Ultra
Fluid.
DO NOT USE LIPIODOL ULTRA FLUID:

If you are allergic to iodised ethyl-esters of the fatty acids of
poppy seed oil (the active substance),

If you have an overactive thyroi

Produktets egenskaber

Health Products Regulatory Authority
09 June 2022
CRN00C437
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipiodol Ultra Fluid 38% w/w Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100% iodised ethyl-esters of the fatty acids of poppy-seed oil
containing approximately 38% w/w organically combined iodine.
This product does not contain any excipient.
3 PHARMACEUTICAL FORM
Solution for injection.
A pale yellow, clear oily liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In diagnostic radiology:
Lipiodol Ultra Fluid is an X-ray contrast medium for use in certain
radiological investigations where it is desired to outline a
viscous or other structure with directly instilled radio-opaque
material.
Lipiodol Ultra Fluid is used in hysterosalpingography in women
undergoing infertility workup.
From most sites in the body it is slowly absorbed, but from the
peritoneal cavity (after hysterosalpingography) absorption is
relatively rapid. On account of its low viscosity Lipiodol ultra Fluid
is suitable for introduction into narrow channels and may
therefore be used in ducts and sinuses.
In interventional radiology:
Visualisation, localisation and carrier of cytotoxic medicine during
Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular
carcinoma at intermediate stage, in adults (see sections 4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IN DIAGNOSTIC RADIOLOGY:
The volume to be administered depends on the particular requirements
of the technique and
the size of the patient.
Recommended dosages
- Lymphography: 3 to 10 mL (maximum 20 mL)
- Hysterosalpingography:
Inject increments of 2 mL of Lipiodol Ultra Fluid into the endometrial
cavity under fluoroscopic control until tubal patency is
determined.
The total volume to be injected depends on the volume of the uterine
cavity, usually not exceeding 15 mL.
The dose of Lipiodol Ultra Fluid for hysterosalpingography should be
kept as low as possible to minimize the potential risk of
thyroid dysfunction; thi