국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PARICALCITOL
ABBVIE SDN BHD
PARICALCITOL
30Capsule Capsules
Catalent Pharma Solutions, LLC
_ _ _ _ _ _ _Consumer Medication Information Leaflet (RiMUP)_ _ _ _ _ ZEMPLAR ® CAPSULES Paricalcitol (1mcg, 2mcg) 1 WHAT IS IN THIS LEAFLET 1. What Zemplar Capsule is used for 2. How Zemplar Capsule works 3. Before you use Zemplar Capsule 4. How to use Zemplar Capsule 5. While you are using it 6. Side effects 7. Storage and disposal of Zemplar Capsule 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ZEMPLAR CAPSULE IS USED FOR Zemplar capsules are indicated for the prevention and treatment of secondary hyperparathyroidism (excess parathyroid hormone in the bloodstream due to overactivity of parathyroid glands) associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4) patients and chronic renal failure (chronic kidney disease stage 5) patients on hemodialysis or peritoneal dialysis (a treatment for kidney failure using an advanced dialysis machine to remove waste products from the blood). HOW ZEMPLAR CAPSULE WORKS Zemplar capsule contains the active ingredient, paracalcitol, which is a man- made active form of vitamin D. Active vitamin D is required for the normal function of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin D, when the body cannot produce enough and helps to prevent the consequences of low levels of active vitamin D, in patients with kidney disease (Stages 3, 4 and 5) namely high levels of parathyroid hormone which can cause bone problems. BEFORE YOU USE ZEMPLAR CAPSULE - _When you must not use it _ Do not take Zemplar - if you are allergic (hypersensitive) to paricalcitol or any of the ingredients of Zemplar. - if you have very high levels of calcium or vitamin D in your blood. Your doctor will be able to tell you if these conditions apply to you _Pregnancy and bre 전체 문서 읽기
PRODUCT NAME Paricalcitol Capsules BRAND NAME Zemplar® PRODUCT DESCRIPTION Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19 –nor) ring. Paricalcitol capsules are available as soft gelatin capsules for oral administration containing 1 microgram of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxy toluene. The capsule shell is composed of gelatin, glycerin, titanium dioxide, iron oxide black (1 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C 27H44O3, which corresponds to a molecular w eight of 416.64. Paricalcitol is chemically designated as 19 - nor -1 α,3 β,25 -trihydroxy -9,10 -secoergosta -5(Z),7( E),22( E)- triene. INDICATIONS Chronic Kidney Disease (CKD) Stages 3 , 4 and 5 Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism as sociated with chronic renal insufficiency (chronic kidney disease stage 3 and 4) patients and chronic renal failure (chronic kidney disease stage 5) patients on hemodialysis or peritoneal dialysis. DOSAGE AND ADMINISTRATION Paricalcitol capsules may be taken without regard to food . CKD Stages 3 and 4 Paricalcitol capsules are administered once a day, either daily or three times a week. When dosing three times a week, administer no more frequently than every other day. The average weekly doses for both daily and three times a week dosage regimens are similar. Although the therapeutic profile is similar in both dosing regimens, daily dosing is recommended as it may enhance patient compliance and reduce medication errors. Initial Dose 전체 문서 읽기