PARICALCITOL FRESENIUS 2 Microgram/ML Solution for Injection
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
11-06-2024
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Δραστική ουσία:
PARICALCITOL
Διαθέσιμο από:
Fresenius Medical Care Nephrologica Deutschland GmbH
INN (Διεθνής Όνομα):
PARICALCITOL
Δοσολογία:
2 Microgram/ML
Φαρμακοτεχνική μορφή:
Solution for Injection
Τρόπος διάθεσης:
Product subject to prescription which may not be renewed (A)
Καθεστώς αδειοδότησης:
Authorised
Ημερομηνία της άδειας:
0000-00-00
Αρχείο Π.Χ.Π.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paricalcitol Fresenius 2 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paricalcitol Fresenius solution 2 mcg/ml
Each 1ml of solution for injection contains 2 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 elevated corrected Ca x
product greater than 5.2 mmol
2
/l
2
(65 mg
2
/dl
2
) is
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