Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
iodised oil, Quantity: 1 mL/mL (Equivalent: iodine, Qty 480 mg/mL)
Guerbet Australia Pty Ltd
Injection, solution
Excipient Ingredients:
Intracavitary, Intrauterine, Intraarterial
1 x 10mL ampoules
Not scheduled. Not considered by committee
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).
Visual Identification: A clean, bright pale yellow oil; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-12-18
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 read_full_document
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 read_full_document