PARICALCITOL FRESENIUS
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
13-06-2024
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Viambatanisho vya kazi:
PARICALCITOL
Inapatikana kutoka:
Fresenius Medical Care Nephrologica Deutschland GmbH
Kipimo:
5 Microgram/ML
Dawa fomu:
Solution for Injection
Idhini ya tarehe:
2011-12-05
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paricalcitol Fresenius 5 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paricalcitol Fresenius solution 5 mcg/ml
Each 1 ml of solution for injection contains 5 micrograms of paricalcitol.
Each 2 ml of solution for injection contains 10 micrograms of paricalcitol.
Excipients: Ethanol anhydrous (11% v/v, 0.110ml/1ml) and propylene glycol
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 Fresenius 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
Paricalcitol Fresenius 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 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 µg.
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/1 (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 el
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