United States - English - 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

United States - English - 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

United States - English - 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

United States - English - 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

Israel - English - 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.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

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

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

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

United States - English - 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

United States - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

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