paricalcitol 2 ug
1 INDICATIONS AND USAGE Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1 ). CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2 ). 1.1 Chronic Kidney Disease Stages 3 and 4 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. 1.2 Chronic Kidney Disease Stage 5 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.
bionpharma inc.
OVAL ORANGE PA2
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16 HOW SUPPLIED/STORAGE AND HANDLING
PARICALCITOL capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules. The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size: Bottles of 30 (NDC 69452-145-13) The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size: Bottles of 30 (NDC 69452-146-13) The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size: Bottles of 30 (NDC 69452-147-13) Storage Store
PARICALCITOL capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.
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