United States - English - NLM (National Library of Medicine)

ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - iodine 140 mg in 1 ml - adults omnipaque 180, 240, and 300 - myelography (lumbar, thoracic, cervical, total columnar) - computerized tomography (ct) (myelography, cisternography, ventriculography) pediatrics omnipaque 180 - myelography (lumbar, thoracic, cervical, total columnar) - ct (myelography, cisternography) adults omnipaque 140 - intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels omnipaque 240 - ct head imaging - peripheral venography (phlebography) omnipaque 300 - aortography including studies of the aortic arch, abdominal aorta and its branches - ct head and body imaging - cerebral arteriography - peripheral venography (phlebography) - peripheral arteriography - excretory urography omnipaque 350 - angiocardiography (ventriculography, selective coronary arteriography) - aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches - ct head and body imaging - intravenous digital subtraction angiography of the head, neck,

United States - English - NLM (National Library of Medicine)

ge healthcare - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - iodine 300 mg in 1 ml - omnipaque imaging bulk package is indicated for - computed tomographic (ct) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/ml) pediatric patients (300 mg iodine/ml) - adults (300 and 350 mg iodine/ml) - pediatric patients (300 mg iodine/ml) for use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with omnipaque imaging bulk package. none. risk summary postmarketing data with omnipaque use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes. iohexol crosses the placenta and reaches fetal tissues in small amounts (see data). in animal reproduction studies, no adverse developmental effects were observed following intravenous iohexol administration to pregnant rats and rabbits during organogenesis at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose (see data) . the estimated background

United States - English - NLM (National Library of Medicine)

interpharma praha, a.s. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - iodine 4.5 g - oraltag is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology. limitations of use oraltag is not indicated for diagnostic examination of the gastrointestinal tract. oraltag is contraindicated in patients with a known hypersensitivity to iodinated contrast agents, including iohexol [see warnings and precautions (5.2)] . risk summary there are no human data on risks associated with the use of oraltag during pregnancy. the background risk in the u.s. general population of major birth defects is 2% to 4% and risk of miscarriage is 15% to 20% of clinically recognized pregnancies. in animal reproduction studies, no evidence of fetal harm was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose. risk summary iohexol administered intravenously is present in human

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 377.5 g (equivalent: iodine, qty 175 g) - injection, solution - excipient ingredients: trometamol; hydrochloric acid; water for injections; sodium calcium edetate - the 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), hemiography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract.,intrathecal: onmipaque is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the cns in adults and children.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 323.5 g (equivalent: iodine, qty 150 g) - injection, solution - excipient ingredients: trometamol; hydrochloric acid; water for injections; sodium calcium edetate - the 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), hemiography, hysterosalpingography, and in adults, children and premature babies for studies of the gastrointestinal tract.,intrathecal: onmipaque is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the cns in adults and children.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 518 mg/ml (equivalent: iodine, qty 240 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; hydrochloric acid; water for injections - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 647 mg/ml (equivalent: iodine, qty 300 mg/l) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; hydrochloric acid; water for injections - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 388 mg/ml (equivalent: iodine, qty 180 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; hydrochloric acid; water for injections - intrathecal: omnipaque is indicated for lumbar, thoracic, cervical and total columnar myelography and in computerised tomography of the cns in adults and children. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 755 mg/ml (equivalent: iodine, qty 350 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; hydrochloric acid; water for injections - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - iohexol, quantity: 647 mg/ml (equivalent: iodine, qty 300 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; hydrochloric acid; water for injections - 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.