Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
iodixanol, Quantity: 652 mg/mL
GE Healthcare Australia Pty Ltd
Iodixanol
Injection, solution
Excipient Ingredients: water for injections; sodium calcium edetate; trometamol; calcium chloride dihydrate; sodium hydroxide; sodium chloride; hydrochloric acid
Intraarterial, Intravenous
20mL x 10
Not scheduled. Not considered by committee
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
Visual Identification: A clear to practically clear, colourless to slightly yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2008-10-29
Visipaque ™ CMI Page 1 of 5 CONSUMER PRODUCT INFORMATION VISIPAQUE™ INJECTION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about VISIPAQUE. It does not contain all the available information. It does not take the place of talking to your radiologist (the specialist doctor who does X-rays), doctor or pharmacist. All preparations of this type have risks and benefits. Your radiologist and/or your doctor have weighed the risks of you receiving VISIPAQUE against the benefits they expect it will have for you. If you have any concerns about being given this preparation, ask your radiologist, doctor or pharmacist. Keep this leaflet. You may need to read it again. WHAT VISIPAQUE IS USED FOR VISIPAQUE is one of a group of medicines known as “contrast media” for diagnostic use. VISIPAQUE is used to improve the clarity of X-ray images of the internal organs of the body by increasing the degree of contrast of different structures within the body. VISIPAQUE is used to study the heart, veins and arteries in the body’s circulatory system and the urinary tract. VISIPAQUE is intended for use in hospitals and radiology clinics only and will be given to you as an injection. Your doctor may have prescribed VISIPAQUE for another reason. Ask your doctor if you have any questions about why VISIPAQUE has been prescribed for you. HOW DOES VISIPAQUE WORK? As VISIPAQUE flows through your blood vessels and organs, the Iodine in VISIPAQUE makes them appear darker during radiographic examinations. This makes them stand out on the X-ray film. This aids the doctor in identifying any problems with a particular organ. BEFORE YOU ARE GIVEN VISIPAQUE WHEN YOU MUST NOT BE GIVEN IT. VISIPAQUE SHOULD NOT BE GIVEN TO YOU IF : 1. You have ever had an allergic reaction to VISIPAQUE or, to any of the ingredients listed at the end of this leaflet (see Product Description) or to any other contrast medium. Symptoms of an allergic reaction may include wheeziness, difficulty in breathing or tightness or pain in the chest, skin ra Perskaitykite visą dokumentą
Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION VISIPAQUE ® (IODIXANOL) INJECTION 1. NAME OF THE MEDICINE Iodixanol 2.&3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM VISIPAQUE 270 mg I/ml and 320 mg I/ml Solution for Injection. ACTIVE INGREDIENT STRENGTH CONTENT PER. ML. Iodixanol (INN) Iodixanol (INN) 270 mg I/ml 320 mg I/ml 550 mg equiv. 270 mg I 652 mg equiv. 320 mg I Solution for injection. VISIPAQUE is supplied ready to use as clear, colourless to pale yellow aqueous solutions. All solutions are terminally sterilised by autoclaving and contain no preservatives. Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble X-ray contrast medium. Pure aqueous solutions of iodixanol in all clinical relevant concentrations have a lower osmolality than whole blood and the corresponding strengths of the non-ionic monomeric contrast media. VISIPAQUE is made isotonic with normal body fluids by addition of electrolytes. For a full list of excipients, see section 6.1 List of Excipients 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. VISIPAQUE is indicated, in adult patients, for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, VISIPAQUE may be used for both conventional radiography and digital subtraction angiography (DSA). In children, VISIPAQUE is indicated for cardioangiography, urography, CT-enhancement and studies of the upper gastrointestinal tract. 4.2 DOSE AND METHOD OF ADMINISTRATION Diagnostic procedures that involve the use of radiopaque imaging agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Page 2 of 17 Preparation of the patient will vary with the particular agent used, preference of the radiologist and the type of radiologic procedure performed. Specific ra Perskaitykite visą dokumentą