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

ge healthcare australia pty ltd - gadodiamide, quantity: 287 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; caldiamide sodium hydrate; water for injections; sodium hydroxide - 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.

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

ge healthcare australia pty ltd - gadodiamide, quantity: 287 mg/ml - injection, solution - excipient ingredients: water for injections; caldiamide sodium hydrate; hydrochloric acid; sodium hydroxide - 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.

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

ge healthcare australia pty ltd - gadodiamide, quantity: 287 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; purified water; hydrochloric acid; caldiamide sodium hydrate - 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 vascularlity 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.

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

ge healthcare - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - 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 ). t

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

ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - omnipaque 300 is indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography). omnipaque should not be administered to patients with a known hypersensitivity to iohexol. myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely. intrathecal administration of corticosteroids with omnipaque is contraindicated. because of the possibility of overdosage, immediate repeat myelography in the event of technical failure is contraindicated (see dosage and administration). omnipaque 350 is indicated in adults for angiocardiography (ventriculography, selective coronary arteriography), aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches, intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels

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.

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

sandoz inc - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to prader-willi syndrome (pws). the diagnosis of pws should be confirmed by appropriate genetic testing [see contraindications (4) and warnings and precautions (5.2)] . omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to manifest catch-up growth by age 2 years. omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with turner syndrome. omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (iss), also called non-growth hormone-deficient short stature, defined by height standard deviation score (sds) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adul

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: sodium calcium edetate; trometamol; sodium hydroxide; water for injections; hydrochloric acid - 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.

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,