Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Iopromide 769 mg/mL equivalent to iodine 370 mg/ml
Bayer New Zealand Limited
Iopromide 769 mg/mL (= iodine 370 mg/ml)
370 mg/mL
Solution for infusion
Active: Iopromide 769 mg/mL equivalent to iodine 370 mg/ml Excipient: Hydrochloric acid Sodium calcium edetate Trometamol Water for injection
Bottle, glass, 100 mL
General sale
General sale
Bayer AG
For intravascular use and use in body cavities. Contrast enhancement in computerised tomography (CT), arteriography and venography, intravenous/intra-arterial digital subtraction angiography (DSA), intravenous urography, use for ERCP, arthrography and examination of other body cavities. ULTRAVIST 240: Also for intrathecal use. ULTRAVIST 370: Especially for angiocardiography. ULTRAVIST 300/370: Not for intrathecal use.
Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, - 200 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, 10 x 50ml - 500 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, 10 x 75mL - 750 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, 10 x 100mL - 1000 mL - 36 months from date of manufacture stored at or below 30°C - Vial, glass, 10 x 30ml - 300 mL - 36 months from date of manufacture stored at or below 30°C protect from light
1988-09-08
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
220125 ULTRAVIST DS – CCDS v15 & v16 Page 1 of 21 NEW ZEALAND DATA SHEET ULTRAVIST ® (IOPROMIDE) 1. NAME OF THE MEDICINE Iopromide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ultravist 240 solution for injection / infusion contains 499 mg of iopromide per mL, equivalent to 240 mg iodine Ultravist 300 solution for injection/infusion contains 623 mg of iopromide per mL, equivalent to 300 mg iodine Ultravist 370 solution for injection/infusion contains 769 mg of iopromide per mL, equivalent to 370mg iodine 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. It contains no antimicrobial preservatives. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is for diagnostic use only. For intravascular use and use in body cavities. Contrast enhancement in computerised tomography (CT), arteriography and venography, intravenous/intra-arterial digital subtraction angiography (DSA), intravenous urography, use for ERCP, arthrography and examination of other body cavities. ULTRAVIST 240: Also for intrathecal use. ULTRAVIST 370: Especially for angiocardiography. ULTRAVIST 300 / 370: Not for intrathecal use. 4.2 DOSE AND METHOD OF ADMINISTRATION ADMINISTRATION TECHNIQUE _VISUAL INSPECTION PRIOR TO USE _ Contrast media should be visually inspected prior to use and must not be used in the presence of particulate matter (including crystals), if discoloured, or if the container is defective in any way. As ULTRAVIST is a highly concentrated solution, crystallisation (evident as a milky-cloudy appearance and/or sediment or floating crystals) may occur very rarely. 220125 ULTRAVIST DS – CCDS v15 & v16 Page 2 of 21 _WARMING PRIOR TO USE _ Contrast media that are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity. ULTRAVIST must not be mixed with any other medicines, su Read the complete document