LIPIODOL ULTRA FLUIDE

Land: Indónesía

Tungumál: indónesíska

Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Virkt innihaldsefni:

ETHER, SOLVENT

Fáanlegur frá:

NICHOLAS LAB INDONESIA - Indonesia

INN (Alþjóðlegt nafn):

ETHER, SOLVENT

Skammtar:

48%

Lyfjaform:

CAIRAN INJEKSI

Einingar í pakka:

DUS, 50 AMPUL @ 10 ML

Framleitt af:

UERBET AULNAY SOUS BOIS - France

Leyfisdagur:

2019-01-21

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
LIPIODOL ULTRA-FLUIDE (480 mg I/ml), solution for injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ethyl esters of iodized fatty acids of poppy seed oil * qs ad for one
ampoule
* Iodine content: 48 %, i.e. 480 mg per ml.
PHARMACEUTICAL FORM
Solution for injection.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
In diagnostic radiology
-
Lymphography
-
Hysterosalpingography (HSG) in women undergoing infertility workup
In interventional radiology
- Visualisation, localisation and vectorisation during Trans-Arterial
Chemo-Embolisation
(TACE) of hepatocellular carcinoma at intermediate stage, in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
LIPIODOL ULTRA-FLUIDE must be administered by slow injection or by
catheter using an
appropriate a glass syringeand a catheter.
In diagnostic radiology
-
Lymphography
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.
-
Hysterosalpingography
Inject increments of 2 mL of LIPIODOL ULTRA FLUIDE 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 FLUIDE for hysterosalpingography should be
kept as low as
possible to minimize the potential risk of thyroid dysfunction.
DISETUJUI OLEH BPOM: 10 OKTOBER 2022
ID EREG10028812100002
Administration in hysterosalpingography is by slow injection into the
uterine cervical canal
via a suitable catheter or cannula. Stop the injection if the patient
develops excessive
discomfort. The examination should be preferably carried out during
the follicular phase of
the menstrual cycle.
In interventional radiology:
• Trans-Arterial Chemo-Embolisation of hepatocellular carcinoma:
The administration is by selective intra-arterial catheterism of the
hepatic artery. The
procedure should b