البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PARICALCITOL
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
H05BX02
SOLUTION FOR INJECTION
PARICALCITOL 5 MCG/ML
I.V
Required
ABBVIE S.R.L., ITALY
PARICALCITOL
PARICALCITOL
Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyrodism associated with chronic renal failure.
2011-12-31
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 اقرأ الوثيقة كاملة