Мальта - английский - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - gadoteric acid - solution for injection - gadoteric acid 279.3 mg - contrast media

Мальта - английский - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - gadoteric acid - solution for injection - gadoteric acid 279.3 mg - contrast media

ЮАР - английский - South African Health Products Regulatory Authority (SAHPRA)

ge healthcare (pty) ltd - injection - see ingredients - each 1,0 ml solution contains gadoteric acid 279,3 mg

Соединенные Штаты - английский - NLM (National Library of Medicine)

guerbet llc - gadopiclenol (unii: s276568koy) (gadopiclenol - unii:s276568koy) - eluciremtm is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (mri) to detect and visualize lesions with abnormal vascularity in: - the central nervous system (brain, spine, and associated tissues), - the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). elucirem is contraindicated in patients with history of hypersensitivity reactions to elucirem. risk summary there are no available data on elucirem use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the available human data on gbca exposure during pregnancy and adverse fetal outcomes are limited and inconclusive (see data). in animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of elucirem during organogenesis (see data). because of the potential risks of gadolinium to the fetus, use elucirem 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 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: animal reproduction studies conducted with gadopiclenol showed some signs of maternal toxicity in rats at 10 mmol/kg and rabbits at 5 mmol/kg (corresponding to 52 times and 57 times the recommended human dose, respectively). this maternal toxicity was characterized in both species by swelling, decreased activity, and lower gestation weight gain and food consumption. no effect on embryo-fetal development was observed in rats at 10 mmol/kg (corresponding to 52 times the recommended human dose). in rabbits, a lower mean fetal body weight was observed at 5 mmol/kg (corresponding to 57 times the recommended human dose) and this was attributed as a consequence of the lower gestation weight gain. risk summary there are no data on the presence of gadopiclenol 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. gadopiclenol is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for elucirem and any potential adverse effects on the breastfed infant from elucirem or from the underlying maternal condition. data in lactating rats receiving single intravenous injection of [153 gd]-gadopiclenol, 0.3% and 0.2% of the total administered radioactivity was transferred to the pups via maternal milk at 6 hours and 24 hours after administration, respectively. furthermore, in nursing rat pups, oral absorption of gadopiclenol was 3.6%. the safety and effectiveness of elucirem for use with mri to detect and visualize lesions with abnormal vascularity in the cns (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) have been established in pediatric patients aged 2 years and older. use of elucirem in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from an open-label, uncontrolled, multicenter, single dose study of elucirem (0.05 mmol/kg) in 80 pediatric patients aged 2 to 17 years. the 80 patients consisted of 60 patients who underwent a cns mri and 20 patients who underwent a body mri [see adverse reactions (6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of elucirem have not been established in pediatric patients younger than 2 years of age. of the total number of elucirem-treated patients in clinical studies, 270 (26%) patients were 65 years of age and over, while 62 (6%) patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. in patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. this may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (nsf). avoid use of gbcas among these patients unless the diagnostic information is essential and not available with non-contrast mri or other modalities. no dose adjustment of elucirem is recommended for patients with renal impairment. elucirem can be removed from the body by hemodialysis [see warnings and precautions (5.2, 5.4, 5.5) and clinical pharmacology (12.3)].

Соединенные Штаты - английский - NLM (National Library of Medicine)

bracco diagnostics inc - gadopiclenol (unii: s276568koy) (gadopiclenol - unii:s276568koy) - vueway® is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (mri) to detect and visualize lesions with abnormal vascularity in: - the central nervous system (brain, spine, and associated tissues), - the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). vueway is contraindicated in patients with history of hypersensitivity reactions to vueway. risk summary there are no available data on vueway use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the available human data on gbca exposure during pregnancy and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of vueway during organogenesis (see data) . because of the potential risks of gadolinium to the fetus, use vueway 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 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: animal reproduction studies conducted with gadopiclenol showed some signs of maternal toxicity in rats at 10 mmol/kg and rabbits at 5 mmol/kg (corresponding to 52 times and 57 times the recommended human dose, respectively). this maternal toxicity was characterized in both species by swelling, decreased activity, and lower gestation weight gain and food consumption. no effect on embryo-fetal development was observed in rats at 10 mmol/kg (corresponding to 52 times the recommended human dose). in rabbits, a lower mean fetal body weight was observed at 5 mmol/kg (corresponding to 57 times the recommended human dose) and this was attributed as a consequence of the lower gestation weight gain. risk summary there are no data on the presence of gadopiclenol 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. gadopiclenol is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vueway and any potential adverse effects on the breastfed infant from vueway or from the underlying maternal condition. data in lactating rats receiving single intravenous injection of [153 gd]-gadopiclenol, 0.3% and 0.2% of the total administered radioactivity was transferred to the pups via maternal milk at 6 hours and 24 hours after administration, respectively. furthermore, in nursing rat pups, oral absorption of gadopiclenol was 3.6%. the safety and effectiveness of vueway for use with mri to detect and visualize lesions with abnormal vascularity in the cns (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) have been established in pediatric patients aged 2 years and older. use of vueway in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from an open-label, uncontrolled, multicenter, single dose study of vueway (0.05 mmol/kg) in 80 pediatric patients aged 2 to 17 years. the 80 patients consisted of 60 patients who underwent a cns mri and 20 patients who underwent a body mri [see adverse reactions (6.1) and clinical pharmacology (12.3)] . the safety and effectiveness of vueway have not been established in pediatric patients younger than 2 years of age. of the total number of vueway-treated patients in clinical studies, 270 (26%) patients were 65 years of age and over, while 62 (6%) patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. in patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. this may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (nsf). avoid use of gbcas among these patients unless the diagnostic information is essential and not available with non-contrast mri or other modalities. no dose adjustment of vueway is recommended for patients with renal impairment. vueway can be removed from the body by hemodialysis [see warnings and precautions (5.2, 5.4, 5.5) and clinical pharmacology (12.3)] .

Бельгия - английский - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ge healthcare a.s. - tetraxetan 202,46 mg/ml; gadolinium oxide 90,62 mg/ml; gadoterate meglumine - eq. gadoteric acid 279,3 mg/ml - solution for injection - gadoteric acid

Бельгия - английский - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ge healthcare a.s. - tetraxetan 202,46 mg/ml; gadolinium oxide 90,62 mg/ml; gadoterate meglumine - eq. gadoteric acid 279,3 mg/ml - solution for injection - gadoteric acid

Ирландия - английский - HPRA (Health Products Regulatory Authority)

bayer limited - gadobutrol - solution for injection - 1.0 millimole(s)/millilitre - paramagnetic contrast media; gadobutrol