LIPIODOL ultra fluid iodised oil 10 mL injection solution ampoule

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

iodised oil, Quantity: 1 mL/mL (Equivalent: iodine, Qty 480 mg/mL)

Доступна с:

Guerbet Australia Pty Ltd

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients:

Администрация маршрут:

Intracavitary, Intrauterine, Intraarterial

Штук в упаковке:

1 x 10mL ampoules

Тип рецепта:

Not scheduled. Not considered by committee

Терапевтические показания :

In diagnostic radiology: Hysterosalpingography in women undergoing infertility workup; lymphangiography; urethrography; radiography of the seminal vesicles, vas deferens and epididymis; nasal sinuses (for which purpose dilution to one-half or one-third strength with liquid paraffin or a suitable vegetable oil is generally advised); dacryocystography; sialography and the exploration of sinuses, fistulae, etc. It has also been used in the form of a 20% emulsion for the X-ray examination of empyema cavities.,In interventional radiology: As an imaging agent for visualisation and localisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma (HCC) at intermediate stage in adults (see section 4.3 -Contraindications and Section 4.4 Special Warnings and Precautions for Use).

Обзор продуктов:

Visual Identification: A clean, bright pale yellow oil; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

1991-12-18

тонкая брошюра

LIPIODOL ULTRA FLUID - Consumer Medicine Information
Page 1 of 3
LIPIODOL ULTRA FLUID
SOLUTION FOR INJECTION
_IODISED OIL _
CONSUMER MEDICINE INFORMATION (CMI)
_ _
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE YOU ARE GIVEN
AN INJECTION OF LIPIODOL
ULTRA FLUID.
It tells you some of the more
important points you need to
know about this product.
IF YOU HAVE ANY QUESTIONS,
WANT TO KNOW MORE ABOUT
LIPIODOL ULTRA FLUID OR
ARE UNSURE ABOUT ANYTHING,
ASK YOUR SPECIALIST OR
RADIOLOGIST.
This leaflet provides only a
summary of the information
known about LIPIODOL ULTRA
FLUID.
Remember that this injection is
only for you. Only a doctor can
prescribe it for you.
WHAT IS LIPIODOL
ULTRA FLUID
LIPIODOL ULTRA FLUID is a
diagnostic agent. It belongs to
the class of iodinated contrast
agents used for radiological
examinations.
LIPIODOL ULTRA FLUID is
used to enhance the contrast of
the images obtained during
these radiological
examinations, which improves
the visualisation and outline of
certain body parts.
When mixed with certain
medicines to treat cancer,
LIPIODOL ULTRA FLUID
carries and delivers the cancer
medicine into the area to be
treated.
LIPIODOL ULTRA FLUID is
used in radiological
examinations of the uterus and
Fallopian tubes when searching
for causes of infertility.
WHAT LIPIODOL
ULTRA FLUID IS
USED FOR
This medicine is used:
•
during radiological
examinations,
•
during surgery.
BEFORE RECEIVING IT
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN
LIPIODOL ULTRA FLUID:
•
If you are allergic to the
active substance, iodised oil,
also known as ethyl ester of
iodised fatty acids of poppy
seed oil,
•
If you need to undergo a
bronchography, a type of X-
ray examination where a
dye is directly administered
into the lower lungs,
•
If you have or have recently
had severe injuries or major
bleeding,
•
If you are pregnant or think
you are pregnant; or have
acute pelvic inflammation,
and are due to undergo
hysterosalpingography, an
examination of the uterus
and fallopian tubes,
•
If

Характеристики продукта

1 (14)
AUSTRALIAN PRODUCT INFORMATION
LIPIODOL
® ULTRA FLUID (IODISED OIL) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Iodised oil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lipiodol Ultra Fluid, 480 mg I/mL, solution for injection is an
iodinated, non water-soluble contrast
agent.
Lipiodol Ultra Fluid is for diagnostic use only.
It is an opaque medium for use in certain radiological investigations,
where it is desired to outline a
viscus or other structure with directly instilled radio-opaque
material. It is slowly absorbed from
most sites in the body, but from the peritoneal cavity (after
hysterosalpingography) absorption is
relatively rapid.
Each ampoule contains 10 mL of the active, ethyl esters of iodised
fatty acids of poppy seed oil
corresponding to an iodine content of 480 mg/mL. This medicine does
not contain any excipients.
Viscosity at 15⁰C: 70 cP (centipoises)
Viscosity at 37⁰C: 25 cP
Relative density at 15⁰C: 1.280
ATC code: V08AD01 (V: other).
3
PHARMACEUTICAL FORM
Solution for injection.
Lipiodol Ultra Fluid is a clear, bright pale yellow, sterile oil in a
glass ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_IN DIAGNOSTIC RADIOLOGY: _
Hysterosalpingography
in
women
undergoing
infertility
workup;
lymphangiography;
urethrography; radiography of the seminal vesicles, vas deferens and
epididymis; nasal sinuses (for
which purpose dilution to one-half or one-third strength with liquid
paraffin or a suitable vegetable
oil is generally advised); dacryocystography; sialography and the
exploration of sinuses, fistulae, etc.
It has also been used in the form of a 20% emulsion for the X-ray
examination of empyema cavities.
_IN INTERVENTIONAL RADIOLOGY: _
As an imaging agent for visualisation and localisation during
Trans-Arterial Chemo-Embolisation
(TACE)
of
hepatocellular
carcinoma
(HCC)
at
intermediate
stage
in
adults
(see
section
4.3
-
Contraindications and Section 4.4 Special Warnings and Precautions for
Use).
2 (14)
4.2
D
OSE AND METHOD OF ADMINISTRATION
Lipiodol Ultra Fluid is for