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.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

ge healthcare sas - gadodiamide 287 mg - solution - 287 mg - pour 1 ml > gadodiamide 287 mg - produit de contraste pour imagerie par résonance - produits de contraste pour imagerie par resonance magnetique (v-divers) - code atc : v08ca03ce médicament est à usage diagnostique uniquement.ce médicament est un produit de contraste radiologique (propriétés opacifiantes), il vous a été prescrit en vue d’un examen par irm (imagerie par résonance magnétique).

Malta - engelsk - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - gadodiamide - solution for injection - gadodiamide - contrast media

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

bracco pty ltd - gadoteridol, quantity: 279.3 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; calteridol calcium; trometamol; sodium hydroxide; water for injections - do not freeze (syringe only). prohance is indicated for use in adults and children from 2 years of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. prohance can also be used for whole body mri.

USA - engelsk - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - gadoxetate disodium (unii: hoy74vze0m) (gadolinium cation (3+) - unii:azv954tz9n) - gadoxetate disodium 181.43 mg in 1 ml - eovist is indicated for intravenous use in magnetic resonance imaging (mri) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease. eovist is contraindicated in patients with history of severe hypersensitivity reactions to eovist [see warnings and precautions ( 5.3 )] . gbcas have been shown to 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 teratogenicity was observed with repeated daily intravenous administration of gadoxetate disodium to rats during organogenesis at doses up to 32 times the recommended single human dose; however, an increase in preimplantation loss was noted at doses 3.2 times the single human dose. post implantation loss was observed with repeated daily intravenous administration of gadoxetate disodium to rabbits on gestation days 6 through 18 at doses 26 times the recommended single human dose (see data) . because of the potential risks of gadolinium to the fetus, use eovist only if imaging is essential during pregnancy and cannot be delayed. the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. 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 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, 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. animal reproductive and developmental toxicity studies were done in rats and rabbits. gadoxetate disodium was not teratogenic when given intravenously during organogenesis to pregnant rats at doses up to 32 times the recommended single human dose (mmol/m2 basis). however, an increase in preimplantation loss was noted at 3.2 times the human dose (mmol/m2 basis). compared to untreated controls, rates of postimplantation loss and absorption increased and litter size decreased when pregnant rabbits received gadoxetate disodium at doses 26 times the recommended human single dose (mmol/m2 basis). this occurred without evidence of maternal toxicity. because pregnant animals received repeated daily doses of gadoxetate disodium, their overall exposure was significantly higher than that achieved with the standard single dose administered to humans. risk summary there is no information regarding the presence of gadoxetate disodium in human milk, the effects of the drug in a breastfed infant, or the effects of the drug on milk production. however, published lactation data on other gbcas report that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk and there is limited gbca gastrointestinal absorption in the breastfed infant. in rat lactation studies with [153 gd] gadoxetate disodium, less than 0.5% of the total administered radioactivity was transferred to the nursing pup. clinical considerations a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for up to 10 hours after eovist administration in order to minimize exposure to a breastfed infant. data animal data in lactating rats given 0.1 mmol/kg [153 gd] gadoxetate disodium, less than 0.5% of the total administered radioactivity was transferred to the neonates via maternal milk, mostly within 2 hours. adequate and well-controlled studies of eovist in pediatric patients have not been conducted. an observational study with eovist was performed in 52 patients (aged > 2 months and < 18 years) referred for evaluation of suspected or known focal liver lesions. eovist improved border delineation and increased contrast of the primary lesion in the majority of patients when compared to non-contrast images. no safety issues were identified. no dose adjustment according to age is necessary in pediatric patients. the safety and effectiveness of eovist have not been established in premature infants. nsf risk no case of nsf associated with eovist or any other gbca has been identified in pediatric patients ages 6 years and younger. juvenile animal data single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. in clinical studies of eovist, 674 (34%) patients were 65 years of age and over, while 20 (1%) were 80 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, use of eovist in an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. in a clinical pharmacology study, slight to moderate differences in pharmacokinetic parameters of gadoxetate disodium (increased auc and terminal half-life, decreased total clearance) were found in a group of geriatric volunteers in comparison to non-geriatric volunteers. no clinically relevant differences in liver contrast enhancement were found. in a clinical pharmacology study in a group of patients with moderate renal impairment, a moderate increase in auc and terminal half-life was observed in comparison to healthy volunteers with normal renal function. hepatic contrast did not differ among the groups. end-stage renal failure may impair eovist imaging performance [see warnings and precautions (5.6)]. in a study of patients with end-stage renal failure, the terminal half-life was prolonged about 12-fold and the auc was increased about 6-fold. hepatic contrast was markedly reduced in these patients, which was attributed to significantly elevated serum ferritin levels [see warnings and precautions ( 5.2 )] . approximately 30% of the injected dose was removed by dialysis in a single 3-hour dialysis session, which started one hour after an eovist dose. eovist was almost completely eliminated via dialysis and biliary excretion within the observation period of 6 days, predominantly within the first 3 days. in a clinical pharmacology study in groups of patients with mild or moderate hepatic impairment, a slight to moderate increase in plasma auc, half-life and urinary excretion, as well as decrease in hepatobiliary excretion was observed in comparison to healthy subjects with normal liver function. hepatic contrast signal did not differ among the groups. severe hepatic impairment may impair eovist imaging performance [see warnings and precautions (5.6)] . in patients with severe hepatic impairment, especially in patients with abnormally high (> 3 mg/dl) serum bilirubin levels, the auc was increased up to 60% and the elimination half-life was increased up to 49%. the hepatobiliary excretion substantially decreased to about 5% of the administered dose and reduced hepatic contrast signal was observed. a dose adjustment is not necessary for patients with hepatic impairment. in clinical studies, 489 patients had a diagnosis of liver cirrhosis (child-pugh category a, n = 270; category b, n = 98; category c, n = 24; unknown category, n = 97). no difference in diagnostic performance and safety was observed among these patients.

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

bracco pty ltd - gadoteridol, quantity: 279.3 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid; trometamol; calteridol calcium - do not freeze (syringe only). prohance is indicated for use in adults and children from 2 years of ge for enhancement of magnetic images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. prohance can also be used for whole body mri.

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

bracco pty ltd - gadoteridol, quantity: 279.3 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; calteridol calcium; trometamol; sodium hydroxide; water for injections - do not freeze (syringe only). prohance is indicated for use in adults and children from 2 years of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. prohance can also be used for whole body mri.

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

bracco pty ltd - gadoteridol, quantity: 279.3 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; calteridol calcium; trometamol; hydrochloric acid; water for injections - do not freeze (syringe only). prohance is indicated for use in adults and children from 2 years ofage for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. prohance can also be used for whole body mri.

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

bracco pty ltd - gadoteridol, quantity: 279.3 mg/ml - injection, solution - excipient ingredients: trometamol; sodium hydroxide; calteridol calcium; water for injections; hydrochloric acid - do not freeze (syringe only). prohance is indicated for use in adults and children from 2 yaers of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. prohance can also be used for whole body mri.

USA - engelsk - NLM (National Library of Medicine)

ge healthcare - gadoterate meglumine (unii: l0nd3981ag) (gadolinium cation (3+) - unii:azv954tz9n) - clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (mri) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (bbb) and/or abnormal vascularity. history of clinically important hypersensitivity reactions to clariscan [see warnings and precautions (5.2)]. 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, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see data) . because of the potential risks of gadolinium to the fetus, use clariscan 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 2-4% and 15-20%, 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 material 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 gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (rhd) based on body surface area (bsa)] to female rats for 14 days before mating, throughout the mating period and until gestation day (gd) 17. pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day (3, 10 and 23 times the rhd based on bsa) from gd6 to gd19. no effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day. this maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption. risk summary there are no data on the presence of gadoterate 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 breastfed infant. gadoterate is present in goat milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clariscan and any potential adverse effects on the breastfed infant from clariscan or from the underlying maternal condition. data nonclinical data demonstrate that gadoterate is detected in goat milk in amounts < 0.1% of the dose intravenously administered. furthermore, in rats, absorption of gadoterate via the gastrointestinal tract is poor (1.2% of the administered dose was absorbed and eliminated in urine). the safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dosage adjustment according to age is necessary in pediatric patients [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of gadoterate meglumine has not been established in preterm neonates. no cases of nsf associated with gadoterate meglumine or any other gbca have been identified in pediatric patients age 6 years and younger [see warnings and precautions (5.1)] . normal estimated gfr (egfr) is approximately 30 ml/minute/1.73 m2 at birth and increases to adult values by 2 years of age. juvenile animal data single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. in clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. in general, use of clariscan in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. no age-related dosage adjustment is necessary. no clariscan dosage adjustment is recommended for patients with renal impairment. gadoterate meglumine can be removed from the body by hemodialysis [see warnings and precautions (5.1) and clinical pharmacology (12.3)].