Paricalcitol 5 microgram/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARICALCITOL

Available from:

Accord Healthcare Limited

ATC code:

H05BX02

INN (International Name):

PARICALCITOL

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PARICALCITOL 5 µg/ml

Prescription type:

POM

Therapeutic area:

CALCIUM HOMEOSTASIS

Authorization status:

Authorised

Authorization date:

2015-02-24

Patient Information leaflet

Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARICALCITOL 2 MICROGRAM/ML SOLUTION FOR INJECTION
PARICALCITOL 5 MICROGRAM/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 Paricalcitol solution for injection is and what it is used for
2.
What you need to know before you use Paricalcitol solution for
injection
3.
How to use Paricalcitol solution for injection
4.
Possible side effects
5.
How to store Paricalcitol solution for injection
6.
Contents of the pack and other information
1.
WHAT PARICALCITOL SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Activated vitamin D is required for normal functioning of many tissues
of the body, including the
kidneys and bones. Paricalcitol solution for injection is a synthetic
manufactured form of activated
vitamin D that is used to prevent and treat high levels of parathyroid
hormone in the blood in people
who have kidney failure and are being treated on a kidney machine
(haemodialysis). High levels of
parathyroid hormone can be caused by low levels of “activated”
vitamin D in patients with kidney
failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARICALCITOL SOLUTION FOR
INJECTION
_ _
DO NOT USE PARICALCITOL SOLUTION FOR INJECTION:
-
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 monitor
your blood levels and be able to tell you if these conditions apply to
you.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Paricalcitol
solution for injection
-
before the treatment beg

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paricalcitol 2 microgram/ml solution for injection
Paricalcitol 5 microgram/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mcg/ml: Each ml of solution for injection contains 2 micrograms of
paricalcitol.
5 mcg/ml: Each ml of solution for injection contains 5 micrograms of
paricalcitol.
2 mcg/ml, 1 ml: Each 1 ml vial contains 2 micrograms of paricalcitol.
5 mcg/ml, 1 ml: Each 1 ml ampoule contains 5 micrograms of
paricalcitol.
5 mcg/ml, 2 ml: Each 2 ml ampoule contains 10 micrograms of
paricalcitol.
5 mcg/ml, 1 ml: Each 1 ml vial contains 5 micrograms of paricalcitol.
5 mcg/ml, 2 ml: Each 2 ml vial contains 10 micrograms of paricalcitol.
Excipients with known effect: Ethanol anhydrous 35 % v/v (276.15
mg/ml) and propylene glycol
30 % v/v (310.8 mg/ml)
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
pH: 6.5 to 9.0
Osmolarity: 11,077 mOsm/L
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paricalcitol is indicated for the prevention and treatment of
secondary hyperparathyroidism in
patients with chronic renal failure 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:
Initial dose (micrograms)
= baseline intact PTH level in pmol/l
8
OR
= baseline intact PTH level in pg/ml
Page 2 of 9
80
and administered as an intravenous (IV) bolus dose no more frequently
than every other day at any
time during dialysis.
The maximum dose safely administered in clinical studies was as high
as 40 micrograms.
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
(150-30