Marekani - Kiingereza - 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

Marekani - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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.

Marekani - Kiingereza - 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 - Kiingereza - 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.

Marekani - Kiingereza - 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,

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

sandoz pty ltd - somatropin, quantity: 3.3 mg/ml - injection - excipient ingredients: poloxamer; dibasic sodium phosphate heptahydrate; benzyl alcohol; sodium hydroxide; monobasic sodium phosphate; mannitol; water for injections; phosphoric acid - omnitrope is intended for long term treatment of children (above three years of age with growth disturbance due to insufficient secretion of pituitary growth hormone; growth disturbance associated with gonadal dysgenesis (turner's syndrome); & growth disturbance associated with chronic renal insufficiency.

Marekani - Kiingereza - NLM (National Library of Medicine)

ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - 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, abdominal, renal and peripheral vessels - peripheral arteriography - excretory urography pediatrics omnipaque 240 - ct head and body imaging omnipaque 300 - angiocardiography (ventriculography) - excretory urography - ct head and body imaging omnipaque 350 - angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) - aortography including the aortic root, aortic arch, ascending and descending aorta adults omnipaque 350 - oral radiographic examination of the gastrointestinal tract pediatrics omnipaque 180, 240 and 300 - oral and rectal radiographic examination of the gastrointestinal tract diluted omnipaque injection adults omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen omnipaque oral solution adults omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen adults omnipaque 240, 300, and 350 - arthrography adults omnipaque 240 - endoscopic retrograde pancreatography (erp) and cholangiopancreatography (ercp) - herniography - hysterosalpingography omnipaque 300 - hysterosalpingography pediatrics omnipaque 240, 300 and 350 diluted - voiding cystourethrography (vcu) - omnipaque 140 and omnipaque 350 are contraindicated for intrathecal use [see warnings and precautions (5.1)] : - omnipaque oral solution 9 and 12 are contraindicated for parenteral administration [see warnings and precautions (5.2)] : - omnipaque body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. risk summary hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see contraindications (4)]. there are no data with iohexol use in pregnant women to inform any drug-associated risks. iohexol crosses the placenta and reaches fetal tissues in small amounts (see data ). in animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. animal data iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy. risk summary published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. there is no information on the effects of the drug on the breastfed infant or on milk production. iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omnipaque and any potential adverse effects on the breastfed infant from omnipaque or from the underlying maternal condition. clinical considerations interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after omnipaque administration to minimize drug exposure to a breastfed infant. intrathecal use the safety and effectiveness of omnipaque 180 have been established in pediatric patients 2 weeks to 17 years of age for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography). use of omnipaque 180 is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. the safety and effectiveness of omnipaque 180 have not been established for intrathecal use in patient pediatric patients less than 2 weeks of age. the safety and effectiveness of omnipaque 240 and 300 have not been established in pediatric patients for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography, or ventriculography). intravascular use angiocardiography ( ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography the safety and effectiveness of omnipaque 300 have been established in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography) and of omnipaque 350 in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography. use of omnipaque 300 and 350 is supported by controlled clinical studies in adults for angiocardiography and aortography, in addition to controlled clinical studies in pediatric patients undergoing angiocardiography, including aortography. the safety and effectiveness of omnipaque 300 have not been established in pediatric patients for aortography. intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography the safety and effectiveness of omnipaque have not been established in pediatric patients for intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography. ct of the head and body the safety and effectiveness of omnipaque 240 and 300 have been established in pediatric patients from birth to 17 years of age for ct imaging of the head and body. use of omnipaque 240 and 300 is supported by controlled clinical studies in adults for head and body ct, in addition to clinical studies in pediatric patients undergoing head ct and in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. the safety and effectiveness of omnipaque 350 have not been established in pediatric patients for ct imaging of the head and body. urography the safety and effectiveness of omnipque 300 have been established in pediatric patients from birth to 17 years of age for urography. use of omnipaque 300 is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. oral or rectal use undiluted omnipaque injection the safety and effectiveness of omnipaque 180, 240, and 300 administered orally and rectally have been established in pediatric patients, from birth to 17 years of age for examination of the gi tract. use of omnipaque 180, 240, and 300 administered orally and rectally is supported by controlled studies in adults for examination of the gi tract, in addition to clinical studies in pediatric patients undergoing examination of the gi tract. oral use in conjunction with intravenous use diluted omnipaque injection the safety and effectiveness of omnipaque injection diluted to concentrations from 9 to 21 mg iodine/ml administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen have been established in pediatric patients from birth to 17 years of age. use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. omnipaque oral solution the safety and effectiveness of omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients have been established in pediatric patients from birth to 17 years of age. use is supported by the data establishing safety and effectiveness for omnipaque injection diluted and administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients. intraarticular use the safety and effectiveness of omnipaque have not been established in pediatric patients for arthrography. body cavity use omnipaque 240, 300, 350 diluted to concentrations from 50 mg iodine/ml to 100 mg iodine/ml is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (vcu). the use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing vcu. the safety and effectiveness of omnipaque have not been established in pediatric patients for ercp, herniography, or hysterosalpingography. in general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [ see adverse reactions (6.1) ]. pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dl or those less than 12 months of age. thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates. some patients were treated for hypothyroidism. after exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see warnings and precautions (5.9)and adverse reactions (6.2)]. in clinical studies of omnipaque for ct, 52/299 (17%) of patients were 70 and over. no overall differences in safety were observed between these patients and younger patients. other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Israeli - Kiingereza - Ministry of Health

cts ltd - tamsulosin hydrochloride - modified release capsules hard - tamsulosin hydrochloride 0.4 mg - treatment of functional symptoms of benign prostatic hyperplasia (bph).