ZEMPLAR 5 MCGML SOLUTION FOR INJECTION

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

PARICALCITOL

Доступно од:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

АТЦ код:

H05BX02

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

PARICALCITOL 5 MCG/ML

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

ABBVIE S.R.L., ITALY

Терапеутска група:

PARICALCITOL

Терапеутска област:

PARICALCITOL

Терапеутске индикације:

Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyrodism associated with chronic renal failure.

Датум одобрења:

2011-12-31

Карактеристике производа

PRESCRIBING INFORMATION
ZEMPLAR 5 MICROGRAMS/ML SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Zemplar 5 micrograms/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipients: Ethanol (20% v/v) and propylene glycol (30% v/v)
For a 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 for the prevention and treatment of
secondary hyperparathyroidism associated with chronic renal
failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zemplar solution for injection is administered via haemodialysis
access.
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
80
and administered as an intravenous (IV) bolus dose not 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-uraemic 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 dosage should be reduced or interrupted until
these parameters are normalised. Then, paricalcitol administration
should be reinitiated at a lower dose. Doses may need to be
decr