REXTOL 5 MCGML

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

PARICALCITOL

Prieinama:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC kodas:

A11CC07

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

PARICALCITOL 5 MCG / 1 ML

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

RAFARM S.A., GREECE

Gydymo sritis:

PARICALCITOL

Terapinės indikacijos:

Rextol 5 mcg/ml is indicated for the prevention and treatment of secondary hyperparathyrodism in patients with chronic renal failure who are undergoing haemodialysis.

Leidimo data:

2023-01-31

Prekės savybės

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rextol 5 mcg/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 anhydrous (11% v/v) and propylene glycol (39% v/v)
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
A clear and colourless aqueous solution that is free from visible
particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rextol 5 mcg/ml is indicated for the prevention and treatment of
secondary
hyperparathyrodism in patients with chronic renal failure 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:
Initial dose (micrograms) = baseline intact PTH level in pmol/l
8
OR
= baseline intact PTH level in pg/mL
80
Page 2 of 10
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.
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 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 decreased as the PTH levels decrease
i