Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
ioversol, Quantity: 741 mg/mL (Equivalent: iodine, Qty 350 mg/mL)
Guerbet Australia Pty Ltd
Injection, solution
Excipient Ingredients: trometamol hydrochloride; trometamol; sodium calcium edetate; sodium hydroxide; hydrochloric acid; water for injections
Intraarterial, Intravenous
1 x 125 mL, 20 x 125 mL, 10 x 125 mL
Not scheduled. Not considered by committee
Shelf Life: Other Conditions: Protect from secondary x-rays. Optiray 350 is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. These include coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. Optiray may be used for intravenous excretary urography.
Visual Identification: Clear, colourless to faint yellow solution.; Container Type: Syringe; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1997-11-10
Page 1 of 6 OPTIRAY® 240 _(Ioversol Injection 51% w/v)_ OPTIRAY® 320 _(Ioversol Injection 68% w/v) _ OPTIRAY® 350 _(Ioversol Injection 74% w/v) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OPTIRAY. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of using OPTIRAY against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING OPTIRAY, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. IN THIS LEAFLET: 1. What is OPTIRAY and what it is used for 2. Before you are given OPTIRAY 3. How OPTIRAY is given 4. When you are given OPTIRAY 5. Possible side effects 6. Product Description 1. WHAT IS OPTIRAY AND WHAT IT IS USED FOR OPTIRAY is an injectable contrast medium. It is used to make clearer diagnostic images of the brain and body in adults and children. As a result, it helps to clearly show abnormalities in the brain or body. This medicine is for diagnostic use only. 2. BEFORE YOU ARE GIVEN OPTIRAY _WHEN YOU MUST NOT USE IT _ Do not use OPTIRAY if you are allergic (hypersensitive): Page 2 of 6 • to the active substance ioversol, or • to any of the other ingredients in OPTIRAY _TAKE SPECIAL CARE WITH OPTIRAY _ Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. _BEFORE YOU START TO USE IT _ TELL YOUR DOCTOR IF: • you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma • you had any reaction to previous injections of a contrast agent, including a previous history of reaction to iodine-based agents • your kidneys do not function properly • OPTIRAY is planned to be used in your child who is under the age of two years TELL YOUR DOCTOR IF: • you are pregnant, intend to become pregnant or breast-fee Прочитајте комплетан документ
1(18) AUSTRALIAN PRODUCT INFORMATION OPTIRAY® 240 (IOVERSOL) SOLUTION FOR INJECTION OPTIRAY® 320 (IOVERSOL) SOLUTION FOR INJECTION OPTIRAY® 350 (IOVERSOL) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ioversol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OPTIRAY (ioversol injection) formulations are sterile, non-pyrogenic, aqueous solutions intended for intravascular administration as diagnostic radiopaque media. Each millilitre of OPTIRAY 240 (ioversol injection 51% w/v) provides 509 mg of ioversol with 3.6 mg of trometamol as a buffer and 0.2 mg of sodium calcium edetate as a stabiliser. OPTIRAY 240 provides 24% (240 mg/mL) organically bound iodine. Each millilitre of OPTIRAY 320 (ioversol injection 68% w/v) provides 678 mg of ioversol with 3.6 mg of trometamol as a buffer and 0.2 mg of sodium calcium edetate as a stabiliser. OPTIRAY 320 provides 32% (320 mg/mL) organically bound iodine. Each millilitre of OPTIRAY 350 (ioversol injection 74% w/v) provides 741 mg of ioversol with 3.6 mg of trometamol as a buffer and 0.2 mg of sodium calcium edetate as a stabiliser. OPTIRAY 350 provides 35% (350 mg/mL) organically bound iodine. The pH of the OPTIRAY formulations has been adjusted to 6.0 to 7.4 with hydrochloric acid or sodium hydroxide. Some physical and chemical properties of these formulations are listed below: OPTIRAY 240 OPTIRAY 320 OPTIRAY 350 Ioversol content (mg/mL) 509 678 741 Iodine content (mg/mL) 240 320 350 Osmolality (mOsm/kg water) 502 702 792 Viscosity (cps) at 25°C 4.6 9.9 14.3 at 37°C 3.0 5.8 9.0 Specific gravity at 37°C 1.281 1.371 1.405 For the full list of excipients, see Section 6.1 List of excipients. 2(18) 3 PHARMACEUTICAL FORM Solution for injection. The OPTIRAY formulations are clear, colourless to pale yellow solutions containing no undissolved solids. Crystallisation does not occur at temperatures above 15°C. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY solutions have osmolalities 1.2 to 2.5 times that of plasma (285 mOsm/kg wat Прочитајте комплетан документ