Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
amidotrizoate meglumine, Quantity: 660 mg/mL; sodium amidotrizoate, Quantity: 100 mg/mL
Bayer Australia Ltd
Injection, solution
Excipient Ingredients: sodium calcium edetate; water for injections
Intravenous, Intraarticular
50mLx10
Not scheduled. Not considered by committee
Intravenous and retrograde urography. Computerized tomography. Also for all angiographic examinations as well as for aminography, arthrography, intraoperative cholangiography, fistulography, hysterosalpingography, splenoportography, vesiculography and others. Urografin is not to be used for myelography, ventriculography of cisternography, since it is likely to provoke neurotoxic symptoms in these examinations.
Visual Identification: Clear solution, colour no darker than B5 or BY5 or Y5; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1992-09-22
UROGRAFIN® 1 UROGRAFIN® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I GIVEN UROGRAFIN? UROGRAFIN contains the active ingredients sodium amidotrizoate and amidotrizoate meglumine. UROGRAFIN is a contrast agent used during an X-ray examination. For more information, see Section 1. Why am I given UROGRAFIN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN UROGRAFIN? Do not use if you have ever had an allergic reaction to UROGRAFIN or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. If you are to have an X-ray of your abdominal area or kidneys, you may be asked to change your diet for 2 days prior and to not eat (fast) after 6pm the evening before your procedure. It is important that you still drink fluids as normal. For more information, see Section 2. What should I know before I am given UROGRAFIN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with UROGRAFIN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW AM I GIVEN UROGRAFIN? UROGRAFIN is injected by the doctor or radiographer into different parts of your body depending on the area of your body to be examined. More instructions can be found in Section 4. How am I given UROGRAFIN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING UROGRAFIN? THINGS YOU SHOULD DO Tell your doctor, radiographer or nurse if you: • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock • experience any asthma symptoms e.g. chest tightening. DRIVING OR USING Prečítajte si celý dokument
1 190213 Urografin PI AUSTRALIAN PRODUCT INFORMATION UROGRAFIN ® Sodium amidotrizoate / Amidotrizoate meglumine Injection 1 NAME OF THE MEDICINE Sodium amidotrizoate / Amidotrizoate meglumine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Urografin 30% contains 40 mg/mL sodium amidotrizoate and 260 mg/mL amidotrizoate meglumine in aqueous solution. Urografin 76% contains 100 mg/mL sodium amidotrizoate and 660 mg/mL amidotrizoate meglumine in aqueous solution. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Presentation Urografin is a clear, colourless to faintly yellowish aqueous solution for injection or infusion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous and retrograde urography. Computerized tomography. Also for all angiographic examinations as well as for amniography, arthrography, intraoperative cholangiography, fistulography, hysterosalpingography, splenoportography, vesiculography and others. Urografin is not to be used for myelography, ventriculography of cisternography, since it is likely to provoke neurotoxic symptoms in these examinations. 4.2 DOSE AND METHOD OF ADMINISTRATION General information • Dietary suggestions In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are emptied of faecal matter and gas. On the two days prior to the examination patients should therefore avoid flatulent food, in particular peas, beans and lentils, salads, fruit, dark and fresh bread and all kinds of uncooked vegetables. On the day before the examination, patients should refrain from eating after 6 p.m. Moreover, it can be appropriate to administer a laxative in the evening. In babies and young children, however, prolonged fasting and the administration of a laxative before the examination are contraindicated. • Hydration Adequate hydration must be assured before and after contrast medium administration. This applies especially to patients with multiple myeloma, diabetes mellitus and nephropathy, polyuria, ol Prečítajte si celý dokument