Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
iopromide, Quantity: 498.72 mg/mL
Bayer Australia Ltd
Injection, solution
Excipient Ingredients: water for injections; trometamol; sodium calcium edetate; dilute hydrochloric acid; sodium hydroxide
Intraarterial, Intracardial, Intrathecal, Intravenous
10 x 100mL bottles
Not scheduled. Not considered by committee
INDICATIONS: Ultravist is indicted for all angiographic and urographic examinations and for contrast enhancements in computerised tomography. Ultravist 240 is additionally indicated for lumbar myelography in adults.
Visual Identification: Clear solution, free of particles.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2001-08-13
ULTRAVIST® 1 ULTRAVIST® 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 ULTRAVIST? ULTRAVIST contains the active ingredient iopromide. ULTRAVIST is a contrast agent used during an X-ray examination. For more information, see Section 1. Why am I given ULTRAVIST? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN ULTRAVIST? Do not use if you have ever had an allergic reaction to ULTRAVIST 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. For more information, see Section 2. What should I know before I am given ULTRAVIST? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ULTRAVIST 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 ULTRAVIST? ULTRAVIST is injected by the doctor, radiographer or nurse 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 ULTRAVIST? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING ULTRAVIST? THINGS YOU SHOULD DO Tell your doctor, radiographer or nurse if you have: • 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 MACHINES Avoid driving a car or operating machinery for 24 hours after receiving ULTRAVIST LABORATORY TEST ULTRAVIST can affect the results of some thyroid tests up to several weeks after receiving it. LOOKING AFTER YOUR MEDICINE The X-Ray unit will store ULTRAVIST Read the complete document
211117 ULTRAVIST PI – CCDS v15 & v16 Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION ULTRAVIST ® (IOPROMIDE) 1. NAME OF THE MEDICINE Iopromide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ultravist 150 injection contains 312 mg of iopromide per mL, equivalent to 150 mg iodine per mL. Ultravist 240 injection contains 499 mg of iopromide per mL, equivalent to 240 mg iodine per mL. Ultravist 300 injection contains 623 mg of iopromide per mL, equivalent to 300 mg iodine per mL. Ultravist 370 injection contains 769 mg of iopromide per mL, equivalent to 370 mg iodine per mL. Iopromide is a triiodinated, non-ionic, water-soluble X-ray contrast medium. PHYSICOCHEMICAL PROPERTIES The iodine concentrations (mg I/mL) available have the following physicochemical properties: Property ULTRAVIST 150 150 mg I/mL ULTRAVIST 240 240 mg I/mL ULTRAVIST 300 300 mg I/mL ULTRAVIST 370 370 mg I/mL Viscosity (mPa.s or cP) at 20°C at 37°C 2.3 1.5 4.9 2.8 8.9 4.7 22.0 10.0 Osmolality at 37°C (osm/kg H 2 O) 0.33 0.48 0.59 0.77 Osmolarity at 37°C (osm/L solution) 0.28 0.36 0.43 0.49 Osmotic pressure Density (g/mL) 20°C Density (g/mL) 37°C 1.164 1.157 1.262 1.255 1.330 1.322 1.409 1.399 Solutions of ULTRAVIST injection 150 mg I/mL, 240 mg I/mL, 300 mg I/mL and 370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that of plasma (285 mOsmol/kg water). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM ULTRAVIST solution for injection/infusion is a clear, colourless to pale yellow solution, free of particles and has a pH of 6.5-8.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ULTRAVIST is indicated for all angiographic and urographic examinations and for contrast enhancement in computerised tomography. ULTRAVIST 240 is additionally indicated for lumbar myelography in adults. 211117 ULTRAVIST PI – CCDS v15 & v16 Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION ADMINISTRATION TECHNIQUE • Contrast media should be visually inspected prior to use and must not be used, if discolour Read the complete document