Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
iohexol, Quantity: 647 mg/mL (Equivalent: iodine, Qty 300 mg/mL)
GE Healthcare Australia Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; trometamol; sodium hydroxide; water for injections; sodium calcium edetate
Intravenous, Intraarterial, Oral
100 mLx10
Medicine Registered
Not scheduled. Not considered by committee
INDICATIONS AS AT 12 NOVEMBER 2003: Intravascular: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography. Oral/Body Cavities: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography and in adults, children and premature babies for studies of the gastrointestinal tract.
Visual Identification: Clear colourless to pale yellow slightly viscous liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1994-03-15
Omnipaque™ CMI Page 1 of 5 CONSUMER PRODUCT INFORMATION OMNIPAQUE™ INJECTION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about OMNIPAQUE. 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 you receiving OMNIPAQUE 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 OMNIPAQUE IS USED FOR OMNIPAQUE is one of a group of medicines known as “contrast media” for diagnostic use. OMNIPAQUE is used in X- ray examinations in many different parts of the body for adults and children. It can make it easier to find and see abnormalities, and improves the diagnostic information needed by the doctor. BEFORE YOU ARE GIVEN OMNIPAQUE WHEN YOU MUST NOT BE GIVEN IT. OMNIPAQUE SHOULD NOT BE GIVEN TO YOU IF : 1. You have ever had or are allergic to OMNIPAQUE, to any of the ingredients listed at the end of this leaflet (see Product Description) or to any other contrast medium. Symptoms of an allergic reaction may include wheeziness, difficulty in breathing or tightness or pain in the chest, skin rash, swelling or itching. 2. You have thyroid gland problems. 3. You have had recent heart disease or problems with your heart. 4. The expiry date on the pack has passed. If you use it after the expiry date, it may have no effect at all, or worse, an entirely unexpected effect. 5. You have an infection or open wound near the site to be examined. 6. You are pregnant or intend to become pregnant. If you receive Omnipaque whilst pregnant, your newborn should be tested to ensure they are producing the correct amount of thyroid hormone. BEFORE YOU ARE GIVEN IT. YOU MUST TELL YOUR DOCTOR IF: 1. You are pregnant, intend to beco Belgenin tamamını okuyun
020507 OMNIPAQUE™ Product Page 1 of 30 AUSTRALIAN PRODUCT INFORMATION OMNIPAQUE TM (IOHEXOL) INJECTION FOR INTRAVASCULAR, ORAL AND BODY CAVITIES AND INTRATHECAL USE 1. NAME OF THE MEDICINE Iohexol 2 . QUALITATIVE AND QUANTITATIVE COMPOSITON OMNIPAQUE 180 mgI/mL, 240 mgI/mL, 300 mgI/mL, 350 mg/mL Solution for Injection Active ingredient Strength Content per mL Iohexol (INN) Iohexol (INN) Iohexol (INN) Iohexol (INN) 180 mg I/ml 240 mg I/ml 300 mg I/ml 350 mg I/ml 388 mg equiv. 180 mg I 518 mg equiv. 240 mg I 647 mg equiv. 300 mg I 755 mg equiv. 350 mg I 020507 OMNIPAQUE™ Product Page 2 of 30 LIST OF EXCIPIENTS For the full list of excipients, see Section 6.1 List of Excipients 3. PHARMACEUTICAL FORM Omnipaque Solution for injection. OMNIP AQ UE is supplied ready to use as clear, colourless to pale yellow, sterile aqueous solutions. OMNIPAQUE at a concentration of 140 mg I/mL is isotonic to blood. OMNIPAQUE contains no preservative. Each vial or bottle should be used only once and any residue discarded. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. INTRAVASCULAR: OMNIPAQUE is indicated in adults for angiography, excretory urography and contrast enhancement in computerised tomography. In children, OMNIPAQUE is indicated for angiography and urography. ORAL/BODY CAVITIES: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract. INTRATHECAL: OMNIPAQUE is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the CNS in adults and children. 4.2 DOSE AND METHOD OF ADMINISTRATION General Administration of contrast media should be performed by qualified personnel familiar with the procedure, and an appropriate technique should be utilised. As in all diagnostic procedures, the lowest dose of OMNIPAQU Belgenin tamamını okuyun