Zemplar 2 micrograms capsules, soft

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Paricalcitol

Tilgjengelig fra:

AbbVie Limited

ATC-kode:

H05BX; H05BX02

INN (International Name):

Paricalcitol

Dosering :

2 microgram(s)

Legemiddelform:

Capsule, soft

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other anti-parathyroid agents; paricalcitol

Autorisasjon status:

Marketed

Autorisasjon dato:

2008-01-25

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZEMPLAR 1 MICROGRAM CAPSULES, SOFT
ZEMPLAR 2 MICROGRAMS CAPSULES, SOFT
paricalcitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zemplar is and what it is used for
2.
What you need to know before you take Zemplar
3.
How to take Zemplar
4.
Possible side effects
5.
How to store Zemplar
6.
Contents of the pack and other information
1.
WHAT ZEMPLAR IS AND WHAT IT IS USED FOR
Zemplar contains the active substance paricalcitol, which is a
synthetic form of active vitamin D.
Active vitamin D is required for the normal functioning 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, namely high
levels of parathyroid hormone which can cause bone problems. Zemplar
is used in adult patients with
kidney disease Stages 3, 4 and 5 and children aged 10 to 16 years with
kidney disease Stages 3 and 4.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEMPLAR
DO NOT TAKE ZEMPLAR
-
if you are allergic to paricalcitol or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have very high levels of calcium or vitamin D in your blood.
Your doctor will be able to tell you if these condi

Preparatomtale

Health Products Regulatory Authority
04 November 2022
CRN00D0D2
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zemplar 2 micrograms capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule of Zemplar 2 microgram contains 2 microgram of
paricalcitol.
Excipient with known effect:
Each capsule of Zemplar 2 microgram contains 1.42 mg of ethanol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, soft
2 micrograms capsule: oval, orange-brown soft capsule imprinted with
ZF
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zemplar is indicated in adult and paediatric patients 10 to 16 years
of age for the prevention and treatment of secondary
hyperparathyroidism associated with chronic kidney disease Stages 3
and 4.
Zemplar is indicated in adult patients for the prevention and
treatment of secondary hyperparathyroidism associated with
chronic kidney disease Stage 5 in patients who are on haemodialysis or
peritoneal dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4
Zemplar should be administered once a day, either daily or three times
a week taken every other day.
INITIAL DOSE
The initial dose is based on baseline intact parathyroid hormone
(iPTH) levels.
TABLE 1. INITIAL DOSE
​
​
BASELINE IPTH LEVEL
DAILY DOSE
THREE TIMES A WEEK DOSE
*
≤ 500 pg/ml (56 pmol/l)
1 microgram
2 micrograms
> 500 pg/ml (56 pmol/l)
2 micrograms
4 micrograms
Health Products Regulatory Authority
04 November 2022
CRN00D0D2
Page 2 of 11
* TO BE ADMINISTERED NO MORE FREQUENTLY THAN EVERY OTHER DAY
DOSE TITRATION
Dosing must be individualised based on serum or plasma iPTH levels,
with monitoring of serum calcium and serum
phosphorus. Table 2 presents a suggested approach for dose titration.
TABLE 2. DOSE TITRATION
​
​
IPTH LEVEL RELATIVE TO BASELINE
DOSE ADJUSTMENT AT 2 TO 4 WEEK
INTERVALS ​
​
DAILY DOSE
THREE TIMES A WEEK DOSE
1
The same or increased
Increase
1 microgram
Increase
2 micrograms
Decreased by