LIPIODOL ULTRA FLUID

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IODINE AS ETHYL ESTERS OF IODIZED FATTY ACIDS OF POPPY SEED OIL

Available from:

PROMEDICO LTD

ATC code:

V08AD

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IODINE AS ETHYL ESTERS OF IODIZED FATTY ACIDS OF POPPY SEED OIL 480 MG/ML

Administration route:

INTRA-LYMPHATIC, INTRA-ARTERIAL

Prescription type:

Required

Manufactured by:

GUERBET, FRANCE

Therapeutic group:

NON WATERSOLUBLE X-RAY CONTRAST MEDIA

Therapeutic indications:

Lymphography.- Visualisation, localisation and vectorisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma, in adults.

Authorization date:

2013-02-19

Summary of Product characteristics

THE FORMAT OF THIS LEAFLET HAS BEEN DEFINED BY THE MOH AND ITS CONTENT
HAS BEEN CHECKED AND APPROVED,
JULY 2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
LIPIODOL ULTRA-FLUID (480 mg I/ml), solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Corresponding to an iodine content of
....................................................................................................
480 mg/mL
in the form of ethyl esters of iodized fatty acids of poppy seed oil
per .............................................................. 1
mL
One 10 mL ampoule contains
......................................................................................................
4800 mg of iodine
Viscosity at 15°C: 70 cP (centipoise)
Viscosity at 37°C: 25 cP
Relative density at 15°C: 1.280
This medicinal product does not contain any excipients.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
In diagnostic radiology
-
Lymphography
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
LIPIODOL ULTRA-FLUID must be administered by slow injection or by
catheter, using an appropriate
glass syringe and a catheter (see Section 6.2 – Incompatibilities).
In diagnostic radiology:

Lymphography
Administer via a catheter inserted into a lymph duct. A dye can first
be injected to locate the lymph
ducts.
The usual dose is 5 to 7 mL via the strict lymphatic route to enhance
contrast in an extremity
(depending on the height of the subject), i.e. 10 to 14 mL for
bilateral lymphography of the feet.
Patients with low weight
The dose must be reduced proportionally in this population.
Elderly
The product must be administered with special care in patients over 65
years of age with underlying
diseases of the cardiovascular, respiratory or nervous systems.
Keeping in mind that part of the
product temporarily embolises the pulmonary capillaries, the dose must
be adjusted in elderly patients
with cardiorespiratory failure or the examination must be cancelled.
4.3. CONTRAINDIC