País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
gadodiamide, Quantity: 287 mg/mL
GE Healthcare Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; purified water; caldiamide sodium hydrate; sodium hydroxide
Intravenous
1 X 10mL
Not scheduled. Not considered by committee
Other conditions: Do not freeze. Omniscan is indicated for use in adults and children from 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood brain barrier or abnormal vascularity. INDICATIONS AS AT 10 DECEMBER 1999: Omniscan is indicated for use in adults and children from 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity and whole body imaging. INDICATIONS AS AT 25 JUNE 2003: OMNISCAN is indicated for: 1) use in adults and children, including infants and neonates less than 6 months of age for the enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity, and; 2) whole body imaging for adults and children over 6 months of age.
Visual Identification: Clear, colourless to slighty yellow, particulate- free solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
1997-10-29
AUSTRALIA CMI PAGE 1 OF 6 OMNISCAN™ CONSUMER MEDICINE INFORMATION AMENDED MARCH 2007 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet tells you about OMNISCAN™. The information in this leaflet applies only to OMNISCAN. This leaflet answers some common questions about OMNISCAN. It does not contain all the available information about the product and is not intended to replace discussions you may wish to have with your doctor, radiologist or other health professional. All medicines have risks and benefits. Your doctors have weighed the risks of you being given this medicine against the benefits they expect it will have for you. PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN OMNISCAN. IF YOU HAVE ANY QUESTIONS, ARE NOT SURE ABOUT ANYTHING OR IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE - ASK YOUR DOCTOR, RADIOGRAPHER OR NURSE. KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. WHAT OMNISCAN IS USED FOR OMNISCAN is one of a group of medicines known as ‹contrast media› which are used in Magnetic Resonance Imaging (MRI) examinations. OMNISCAN is used in MRI examinations of the brain or spine, as well as other parts of the body. OMNISCAN makes it easier to detect and locate changes and to improve the diagnostic information your radiologist needs. OMNISCAN is intended for use in hospitals and radiology clinics only. OMNISCAN is for use in adults, children and babies over 4 weeks of age. HOW OMNISCAN WORKS MRI uses the magnetic properties of molecules in the body to “see” organs and other structures in the body and how they may have changed as a result of any condition you may have. OMNISCAN can greatly improve the clarity of the images the radiologist looks at to enable better, and more accurate, diagnosis of your condition. AUSTRALIA CMI PAGE 2 OF 6 OMNISCAN™ CONSUMER MEDICINE INFORMATION AMENDED MARCH 2007 WHAT IS IN OMNISCAN The name of your medicine is OMNISCAN. It contains an active substance known as gadodiamide. OMNISCAN is a sterile, aqueous solution for injection, and con Llegiu el document complet
OMNISCAN TM PRODUCT INFORMATION 80307 AUSTRALIA PI PAGE 1 OF 17 AUSTRALIAN PRODUCT INFORMATION 1. NAME OF MEDICINE GADODIAMIDE 2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Sterile Aqueous Injection 287 mg/mL OMNISCAN (gadodiamide) injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, non-ionic, linear, paramagnetic, extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is to be administered by intravenous injection. OMNISCAN is provided as a sterile, clear, and colourless to slightly yellow aqueous solution. Each mL contains 287 mg gadodiamide, 12 mg caldiamide sodium and water for injection. The pH is adjusted between 6.0 and 7.0 with hydrochloric acid or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OMNISCAN is indicated for: 1) use in adults and children, including infants and neonates less than 6 months of age for the enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity, and; 2) whole body imaging for adults and children over 6 months of age. AUSTRALIA PI PAGE 2 OF 18 OMNISCAN TM PRODUCT INFORMATION 80307 4.2 DOSE AND METHOD OF ADMINISTRATION Gadolinium containing contrast agents (GdCAs) should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). No special preparation of the patient is required. OMNISCAN should be drawn into the syringe immediately before use. For use in single patient only and any unused portion must be discarded. For intravenous use. The required dose should be administered as a single intravenous injection. To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL, sodium chloride 0.9% (normal saline flush). Unless otherwise specified, the imaging procedure should be completed within 1 hour of admi Llegiu el document complet