দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
iopamidol, Quantity: 755.3 mg/mL (Equivalent: iodine, Qty 370 mg/mL)
Bracco Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; trometamol; hydrochloric acid; sodium calcium edetate
Intravenous, Intraarterial
50mL x 1
Not scheduled. Not considered by committee
In adults, Isovue is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, peripheral venography (phlebography), coronary arteriography and ventriculography, selective visceral arteriography and aortography, intravenous excretory urography and contrast enhancement of computed tomographic head and body imaging. Isovue is also indicated for myelography (lumbar, total columnar) and for contrast enhancement in computed tomography of the central nervous system. In children, Isovue is indicated for intravascular use only, including intravenous excretory urography.
Visual Identification: Clear colourless liquid; Container Type: Vial; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1993-12-06
ISOVUE® CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers common questions about ISOVUE®. 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 your receiving ISOVUE® 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 IS ISOVUE® ISOVUE® is the trade name for iopamidol, an iodine‐containing dye, called a “contrast medium”. It comes as a solution for injection in ampoules or vials. WHAT ISOVUE® IS USED FOR AND HOW IT WORKS ISOVUE® is used for making blood vessels and other parts of the body visible to X‐rays. Injection of ISOVUE® into the blood vessels dyes the blood vessels through which the blood flows. This allows the blood vessels in that area to be seen on an X‐ray. Injection of ISOVUE® into the spinal cord allows the nerves within the spine to be seen on an X‐ray. The resulting X‐ray photographs may help your doctor to diagnose your illness or problem. In children, Isovue® is injected only into the blood vessels. BEFORE YOU HAVE AN INJECTION OF ISOVUE® _YOU MUST NOT HAVE AN INJECTION OF _ISOVUE®: •If you are ALLERGIC TO IOPAMIDOL OR TO ANY OF THE INGREDIENTS IN ISOVUE® (listed under “PRODUCT DESCRIPTION, WHAT IT LOOKS LIKE”, at the end of this leaflet) or to any other iodine‐containing contrast media. There have been some cases of severe and life‐threatening reactions occurring with iodine‐containing contrast media. The possibility of such reactions occurring with ISOVUE® therefore cannot be ruled out. Your radiologist has appropriate medicines and equipment on hand to treat you, in the unlikely event that you should experience a reaction to ISOVUE®. সম্পূর্ণ নথি পড়ুন
AUSTRALIAN PRODUCT INFORMATION – ISOVUE ® 300 (IOPAMIDOL) AND ISOVUE ® 370 (IOPAMIDOL) 1 NAME OF THE MEDICINE Iopamidol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isovue ® 300 (lopamidol Injection 61%) provides 612mg iopamidol. Isovue ® 370 (lopamidol Injection 76%) provides 755 mg iopamidol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection, solution. Clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults, Isovue ® is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, peripheral venography (phlebography), coronary arteriography and ventriculography, selective visceral arteriography and aortography, intravenous excretory urography and contrast enhancement of computed tomographic head and body imaging. Isovue ® is also indicated for myelography (lumbar, total columnar) and for contrast enhancement in computed tomography of the central nervous system. In children, Isovue ® is indicated for intravascular use only, including intravenous excretory urography. 4.2 DOSE AND METHOD OF ADMINISTRATION Depending on age, weight, cardiac output, general state of health, the clinical problem, examination technique, kind and volume of the region to be examined, an appropriate dose should be used. Examinations of infants and children always require individualisation of dosages, to be chosen in the first place in relation to the region to be demonstrated, the weight and the age. It is desirable that solutions of radiopaque diagnostic agents for intrathecal or intravascular use be at body temperature when injected. Isovue ® solutions should be used only if clear and within the normal colourless to pale yellow range. In the event that crystallisation of the medium has occurred, the solution should not be used. Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast a সম্পূর্ণ নথি পড়ুন