ZEMPLAR CAPSULES 1 MCG

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

PARICALCITOL

Disponible depuis:

ABBVIE SDN BHD

DCI (Dénomination commune internationale):

PARICALCITOL

Unités en paquet:

30Capsule Capsules

Fabriqué par:

Catalent Pharma Solutions, LLC

Notice patient

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_Consumer Medication Information Leaflet (RiMUP)_
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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

Résumé des caractéristiques du produit

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