미국 - 영어 - NLM (National Library of Medicine)

physicians total care, inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in adults. safety and effectiveness of balsalazide disodium capsules beyond 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clea

미국 - 영어 - 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.

미국 - 영어 - NLM (National Library of Medicine)

bausch health us, llc - edetate calcium disodium (unii: 25ih6r4sgf) (edetic acid - unii:9g34hu7rv0) - edetate calcium disodium 200 mg in 1 ml - edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead. edetate calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.

미국 - 영어 - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - etidronate disodium (unii: m16pxg993g) (etidronic acid - unii:m2f465roxu) - etidronate disodium 200 mg - etidronate disodium tablets, usp are indicated for the treatment of symptomatic paget’s disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. etidronate disodium tablets are not approved for the treatment of osteoporosis. etidronate disodium tablets are indicated for the treatment of symptomatic paget’s disease of bone. etidronate disodium therapy usually arrests or significantly impedes the disease process as evidenced by: in addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients. in many patients, the disease process will be suppressed for a period of at least one year following cessation of therapy. the upper limit of this period has not been determined. the effects of the etidronate disodium treatment in patients with asymptomatic paget’s disease have not been studied. however, etidronate disodium treatment of such patients may be warranted if extensive invo

미국 - 영어 - NLM (National Library of Medicine)

areva pharmaceuticals inc. - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium for injection usp, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium for injection usp. vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 l/day throughout treatment. mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. diuretic therapy should not be employed prior to correction of hypovolemia. the safety and efficacy of pamidronate disodium for injection usp in the treatment of hypercalcemia associated with hyperparat

미국 - 영어 - NLM (National Library of Medicine)

mylan institutional llc - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 l/day throughout treatment. mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. diuretic therapy should not be employed prior to correction of hypovolemia. the safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions h

미국 - 영어 - NLM (National Library of Medicine)

hospira, inc. - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 6 mg in 1 ml - hypercalcemia of malignancy   pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 l/day throughout treatment. mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. diuretic therapy should not be employed prior to correction of hypovolemia. the safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. paget’s disease   pamidronate disodium is indicated for the treatment of patients with moderate to severe paget’s disease of bone. the effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥ 3 times the upper limit of normal. pamidronate disodium therapy in patients with paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥ 50% in at least 50% of patients, and by ≥ 30% in at least 80% of patients. pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with paget’s disease who failed to respond, or no longer responded to other treatments. osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. the pamidronate disodium treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see clinical pharmacology, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma, clinical trials section). pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

미국 - 영어 - NLM (National Library of Medicine)

golden state medical supply, inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. limitations of use: safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see warnings and precautions (5.3), adverse reactions ( 6.2), description ( 11)] . risk summary: published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are adve

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - flurbiprofen sodium dihydrate, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: polyvinyl alcohol; potassium chloride; sodium chloride; sodium citrate dihydrate; citric acid monohydrate; disodium edetate; thiomersal; sodium hydroxide; hydrochloric acid; purified water - for the inhibition of intraoperative miosis.

미국 - 영어 - NLM (National Library of Medicine)

edetate disodium, anhydrous (unii: 8nlq36f6mm) (edetic acid - unii:9g34hu7rv0) - injection, solution - endrate (edetate disodium injection, usp) is indicated in selected patients for the emergency treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity. endrate (edetate disodium injection, usp) is contraindicated in anuric patients. it is not indicated for the treatment of generalized arteriosclerosis associated with advancing age.