Lipiodol Ultra Fluid

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Iodised oil 38%{relative} (eqv to 48% w/v iodine);  

Beschikbaar vanaf:

Obex Medical Ltd

INN (Algemene Internationale Benaming):

Iodised oil 38% w/w

Dosering:

38% w/w

farmaceutische vorm:

Solution for injection

Samenstelling:

Active: Iodised oil 38%{relative} (eqv to 48% w/v iodine)  

Eenheden in pakket:

Ampoule, 1 x 10mL, 10 mL

klasse:

General sale

Prescription-type:

General sale

Geproduceerd door:

Simafex

therapeutische indicaties:

In diagnostic radiology LIPIODOL ULTRA FLUID is used in lymphography, hysterosalpingography in women undergoing infertility workup and sialography.

Product samenvatting:

Package - Contents - Shelf Life: Ampoule, glass, 1 x 10mL - 10 mL - 36 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1965-11-15

Productkenmerken

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
LIPIODOL ULTRA FLUID (480 mg iodine/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 iodised 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
LIPIODOL ULTRA FLUID is used in lymphography, hysterosalpingography in
women undergoing
infertility workup and sialography.
In interventional radiology
Visualisation and localisation during Trans-Arterial Chemo
Embolisation (TACE) of hepatocellular
carcinoma (HCC) at intermediate stage in adults.
4.2. DOSE AND METHOD OF ADMINISTRATION
LIPIODOL ULTRA FLUID must be administered by slow injection or by
catheter, using glass syringes or
other devices which have studies demonstrating the compatibility with
LIPIODOL ULTRA FLUID.
Instructions for use applicable to those devices should be followed
(see Section 6.2).
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 patient), i.e. 10 to 14 mL for bilateral
lymphography of the feet. The dose must be
reduced proportionally in children. In infants 1 to 2 years of age, a
dose of 1 mL per extremity is
sufficient.
•
Hysterosalpingography
Inject increments of 2 mL of LIPIODOL ULTRA FLUID into the endometrial
cavity under fluoroscopic
control until tu