Zemplar 5 micrograms/ml Solution for Injection, glass vial

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paricalcitol

Available from:

AbbVie Limited

ATC code:

H05BX; H05BX02

INN (International Name):

Paricalcitol

Dosage:

5 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other anti-parathyroid agents; paricalcitol

Authorization status:

Marketed

Authorization date:

2014-08-01

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZEMPLAR 5 MICROGRAMS/ML SOLUTION FOR INJECTION
paricalcitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 are given Zemplar
3.
How Zemplar is used
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, in patients
with chronic kidney disease namely high levels of parathyroid hormone
which can cause bone
problems. Zemplar is used in adult patients with kidney disease Stages
5.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEMPLAR
YOU SHOULD NOT BE GIVEN 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 conditions apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before being given Zemplar.
-
before the treatment begins, it is important to limit the amount of
phospho

Summary of Product characteristics

Health Products Regulatory Authority
03 July 2020
CRN009RM0
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zemplar 5 micrograms/ml Solution for Injection, glass vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zemplar 5 micrograms/ml solution for injection:
Each ml of solution for injection contains 5 micrograms of
paricalcitol.
Each 1 ml ampoule contains 5 micrograms of paricalcitol.
Each 2 ml ampoule contains 10 micrograms of paricalcitol.
Each 1 ml vial contains 5 micrograms of paricalcitol.
Each 2 ml vial contains 10 micrograms of paricalcitol.
Excipients with known effect:
Ethanol (20% v/v) and propylene glycol (30% v/v)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear and colourless aqueous solution free from visible particles
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paricalcitol is indicated in adults for the prevention and treatment
of secondary hyperparathyroidism in patients with chronic
kidney disease Stage 5 who are undergoing haemodialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
1) Initial dose should be calculated based on baseline parathyroid
hormone (PTH) levels:
The initial dose of paricalcitol is based on the following formula:
and administered as an intravenous (IV) bolus dose no more frequently
then every other day at any time during dialysis.
The maximum dose safely administered in clinical studies was as high
as 40 micrograms.
Health Products Regulatory Authority
03 July 2020
CRN009RM0
Page 2 of 9
2) Titration dose:
The currently accepted target range for PTH levels in end-stage renal
failure subjects undergoing dialysis is no more than 1.5 to
3 times the non-uremic upper limit of normal, 15.9 to 31.8 pmol/l
(150-300 pg/ml), for intact PTH. Close monitoring and
individual dose titration are necessary to reach appropriate
physiological endpoints. If hypercalcaemia or a persistently
elevated corrected Ca x P product greater than 5.2 mmol
2
/l
2
(65 mg
2
/dl
2
) is noted, the dosa