アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

bryant ranch prepack - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

bryant ranch prepack - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.1) ]. vitamin d toxicity [see warnings and precautions ( 5.1) ]. risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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. clinical considerations disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m 2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [ 3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [ 3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [ 3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

bryant ranch prepack - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.1) ]. vitamin d toxicity [see warnings and precautions ( 5.1) ]. risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [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. clinical considerations disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m 2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [ 3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [ 3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [ 3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

lotus pharmaceutical co., ltd. nantou plant - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m 2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m 2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times the 14 mcg human dose based on sur

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional llc - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (ckd) on dialysis. paricalcitol is contraindicated in patients with: risk summary limited data with paricalcitol in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see clinical considerations) . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, a human dose of 14 mcg (equivalent to 0.24 mcg/kg), based on body surface area (mg/m2 ). adverse reproductive outcomes were observed at doses that caused maternal toxicity (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is u

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

eugia us llc - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (ckd) on dialysis. paricalcitol is contraindicated in patients with: - hypercalcemia [see warnings and precautions (5.1)] - vitamin d toxicity [see warnings and precautions (5.1)] - known hypersensitivity to paricalcitol or any of the inactive ingredients in paricalcitol. hypersensitivity adverse reactions have been reported [e.g., angioedema (including laryngeal edema) and urticaria] [see adverse reactions (6.2)] . risk summary limited data with paricalcitol in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see clinical considerations) . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously duri

イスラエル - 英語 - Ministry of Health

abbvie biopharmaceuticals ltd, israel - paricalcitol - solution for injection - paricalcitol 5 mcg/ml - paricalcitol - paricalcitol - paricalcitol is indicated for the prevention and treatment of secondary hyperparathyrodism associated with chronic renal failure.

パナマ - 英語 - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

sandoz gmbh - paricalcitol - paricalcitol....0.005 mg

パナマ - 英語 - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

accord healthcare, s.l.u. - paricalcitol - paricalcitol....5.00 mcg

アイルランド - 英語 - HPRA (Health Products Regulatory Authority)

fresenius medical care nephrologica deutschland gmbh - paricalcitol - solution for injection - 2 microgram/ml