LIPIODOL ULTRA FLUID

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

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Lastnosti izdelka Lastnosti izdelka (SPC)
25-01-2024
Javno poročilo o oceni Javno poročilo o oceni (PAR)
07-03-2022

Aktivna sestavina:

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

Dostopno od:

PROMEDICO LTD

Koda artikla:

V08AD

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

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

Pot uporabe:

INTRA-LYMPHATIC, INTRA-ARTERIAL

Tip zastaranja:

Required

Izdeluje:

GUERBET, FRANCE

Terapevtska skupina:

NON WATERSOLUBLE X-RAY CONTRAST MEDIA

Terapevtske indikacije:

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

Datum dovoljenje:

2022-02-28

Lastnosti izdelka

                                1
Lipiodol SPC vr 02A
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
LIPIODOL ULTRA-FLUID
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
for ................................................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
-
Lymphography.
-
Visualisation, localisation and vectorisation during Trans-Arterial
Chemo-Embolisation (TACE) of
hepatocellular carcinoma, in adults.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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. Given
that part of the product
temporarily embolises the pulmonary capillaries, the dose must be
adjusted in elderly patients with
cardiorespiratory insufficiency or the examination must be cancelled.
In interventional radiology
•
Trans-Arterial Chemo-Embolisation of hepatocellular carcinoma
:
2
Lipiodol SPC vr 02A
The dose of LIPIODOL ULTRA-FLUID depends on the extent of the lesion,
but should usually not
exceed a total dose of 15 mL 
                                
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