USA - engelsk - NLM (National Library of Medicine)

ge healthcare inc. - gadodiamide (unii: 84f6u3j2r6) (gadodiamide - unii:84f6u3j2r6) - omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see clinical studies (14.1)]. omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see clinical studies (14.2)]. omniscan is contraindicated in patients with: - chronic, severe kidney disease (glomerular filtration rate, gfr < 30 ml/min/1.73m2 ) or acute kidney injury - prior hypersensitivity to omniscan risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, no adverse fetal effects were observed with administration of gadodiamide to pregnant rats during organogenesis at doses 1.3 times the maximum human dose based on body surface area (see data) . because of the potential risks of gadolinium to the fetus, use omniscan only if imaging is essential during pregnancy and cannot be delayed. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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 contrast enhancement is visualized in the human placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the maternal indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. reproductive toxicology gadodiamide has been shown to have an adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/kg/day for 13 days during gestation (approximately 0.6 times the human dose based on a body surface area comparison). these adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since the body weight of the dams was reduced in response to gadodiamide administration during pregnancy. in rat studies, fetal abnormalities were not observed at doses up to 2.5 mmol/kg/day for 10 days during gestation (1.3 times the maximum human dose based on a body surface area comparison); however, maternal toxicity was not achieved in these studies and a definitive conclusion about teratogenicity in rats at doses above 2.5 mmol/kg/day cannot be made. risk summary there are no data on the presence of gadodiamide in human milk, the effects on the breastfed infant, or the effects on milk production. however, published lactation data on other gbcas indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. additionally, there is limited gbca gastrointestinal absorption in the breast-fed infant. animal data show transfer of gadodiamide into rat milk (see data). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omniscan and any potential adverse effects on the breastfed infant from omniscan or from the underlying maternal condition. data gadodiamide is detected in the breast milk of rats injected intravenously with 0.3 mmol/kg up to 4 hours post dosing and is below the level of quantification after 8 hours. the safety and efficacy of omniscan at a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients over 2 years of age based on adequate and well controlled studies of omniscan in adults, a pediatric cns imaging study, and safety data in the scientific literature. however, the safety and efficacy of doses greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients. pharmacokinetics of omniscan have not been studied in pediatrics. the glomerular filtration rate of neonates and infants is much lower than that of adults. the pharmacokinetics volume of distribution is also different. therefore, the optimal dosing regimen and imaging times in patients under 2 years of age have not been established. in clinical studies of omniscan, 243 patients were between 65 and 80 years of age while 15 were over 80 years of age. no overall differences in safety or effectiveness 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 in the elderly 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. omniscan is excreted by the kidney, and the risk of toxic reactions to omniscan may be greater in patients with impaired renal function [see warnings and precautions (5.4)]. because elderly patients are more likely to have decreased renal function, select dose carefully and consider assessment of renal function before omniscan use. dose adjustments in renal or hepatic impairment have not been studied. caution should be exercised in patients with impaired renal insufficiency [see warnings and precautions (5.2, 5.5)].

USA - engelsk - NLM (National Library of Medicine)

ge healthcare inc. - gadodiamide (unii: 84f6u3j2r6) (gadodiamide - unii:84f6u3j2r6) - gadodiamide 287 mg in 1 ml - omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see clinical studies (14.1)]. omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see clinical studies (14.2)]. omniscan is contraindicated in patients with: - chronic, severe kidney disease (glomerular filtration rate, gfr < 30 ml/min/1.73m2 ) or acute kidney injury - prior hypersensitivity to omniscan risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, no adverse

USA - engelsk - NLM (National Library of Medicine)

ge healthcare inc. - gadodiamide (unii: 84f6u3j2r6) (gadodiamide - unii:84f6u3j2r6) - gadodiamide 287 mg in 1 ml - omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see clinical studies (14.1)]. omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see clinical studies (14.2)]. omniscan is contraindicated in patients with: - chronic, severe kidney disease (glomerular filtration rate, gfr < 30 ml/min/1.73m2 ) or acute kidney injury - prior hypersensitivity to omniscan gbcas cross the placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive. because of the potential risks of gadolinium to the fetus, use omniscan only if imaging is essential during pregnancy and cannot be delayed. contrast enhancement is visualized in the human placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the maternal indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. omniscan has been shown to have an adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/kg/day for 13 days during gestation (approximately 0.6 times the human dose based on a body surface area comparison). these adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since the body weight of the dams was reduced in response to omniscan administration during pregnancy. in rat studies, fetal abnormalities were not observed at doses up to 2.5 mmol/kg/day for 10 days during gestation (1.3 times the maximum human dose based on a body surface area comparison); however, maternal toxicity was not achieved in these studies and a definitive conclusion about teratogenicity in rats at doses above 2.5 mmol/kg/day cannot be made. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, exercise caution when administering omniscan to a nursing woman. the safety and efficacy of omniscan at a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients over 2 years of age based on adequate and well controlled studies of omniscan in adults, a pediatric cns imaging study, and safety data in the scientific literature. however, the safety and efficacy of doses greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients. pharmacokinetics of omniscan have not been studied in pediatrics. the glomerular filtration rate of neonates and infants is much lower than that of adults. the pharmacokinetics volume of distribution is also different. therefore, the optimal dosing regimen and imaging times in patients under 2 years of age have not been established. in clinical studies of omniscan, 243 patients were between 65 and 80 years of age while 15 were over 80. no overall differences in safety or effectiveness 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 in the elderly 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. omniscan is excreted by the kidney, and the risk of toxic reactions to omniscan may be greater in patients with impaired renal function [see warnings and precautions (5.4)]. because elderly patients are more likely to have decreased renal function, select dose carefully and consider assessment of renal function before omniscan use. dose adjustments in renal or hepatic impairment have not been studied. caution should be exercised in patients with impaired renal insufficiency [see warnings and precautions (5.2, 5.5) ].

Latvia - latvisk - Zāļu valsts aģentūra

ge healthcare as, norway - gadodiamīds - Šķīdums injekcijām - 0,5 mmol/ml

Norge - norsk - Statens legemiddelverk

ge healthcare as - gadodiamid - injeksjonsvæske, oppløsning i ferdigfylt sprøyte - 0.5 mmol/ ml

Norge - norsk - Statens legemiddelverk

ge healthcare as - gadodiamid - injeksjonsvæske, oppløsning - 0.5 mmol/ ml

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

ge healthcare a.e. - gadodiamide - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 0,5mmol (287mg)/ml - ineof00854 - gadodiamide - 287.000000 mg - gadodiamide

Brasil - portugisisk - ANVISA (Agência Nacional de Vigilância Sanitária)

ge healthcare do brasil comÉrcio e serviÇos para equipamentos medico-hospitalares ltda - gadodiamida - contrastes radiologicos

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

ge healthcare australia pty ltd - gadodiamide, quantity: 287 mg/ml - injection - excipient ingredients: caldiamide sodium hydrate; sodium hydroxide; water for injections; hydrochloric acid - 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 - engelsk - Department of Health (Therapeutic Goods Administration)

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