Country: Malta
Language: English
Source: Medicines Authority
PARICALCITOL
Accord Healthcare Limited
H05BX02
PARICALCITOL
SOLUTION FOR INJECTION
PARICALCITOL 2 µg/ml
POM
CALCIUM HOMEOSTASIS
Authorised
2015-02-24
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARICALCITOL 2 MICROGRAM/ML SOLUTION FOR INJECTION PARICALCITOL 5 MICROGRAM/ML SOLUTION FOR INJECTION paricalcitol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Paricalcitol solution for injection is and what it is used for 2. What you need to know before you use Paricalcitol solution for injection 3. How to use Paricalcitol solution for injection 4. Possible side effects 5. How to store Paricalcitol solution for injection 6. Contents of the pack and other information 1. WHAT PARICALCITOL SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Activated vitamin D is required for normal functioning of many tissues of the body, including the kidneys and bones. Paricalcitol solution for injection is a synthetic manufactured form of activated vitamin D that is used to prevent and treat high levels of parathyroid hormone in the blood in people who have kidney failure and are being treated on a kidney machine (haemodialysis). High levels of parathyroid hormone can be caused by low levels of “activated” vitamin D in patients with kidney failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARICALCITOL SOLUTION FOR INJECTION _ _ DO NOT USE PARICALCITOL SOLUTION FOR INJECTION: - if you are allergic to paricalcitol or any of the other ingredients of this medicine listed in section 6. - if you have very high levels of calcium or vitamin D in your blood. Your doctor will monitor your blood levels and be able to tell you if these conditions apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Paricalcitol solution for injection - before the treatment beg Read the complete document
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paricalcitol 2 microgram/ml solution for injection Paricalcitol 5 microgram/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2 mcg/ml: Each ml of solution for injection contains 2 micrograms of paricalcitol. 5 mcg/ml: Each ml of solution for injection contains 5 micrograms of paricalcitol. 2 mcg/ml, 1 ml: Each 1 ml vial contains 2 micrograms of paricalcitol. 5 mcg/ml, 1 ml: Each 1 ml ampoule contains 5 micrograms of paricalcitol. 5 mcg/ml, 2 ml: Each 2 ml ampoule contains 10 micrograms of paricalcitol. 5 mcg/ml, 1 ml: Each 1 ml vial contains 5 micrograms of paricalcitol. 5 mcg/ml, 2 ml: Each 2 ml vial contains 10 micrograms of paricalcitol. Excipients with known effect: Ethanol anhydrous 35 % v/v (276.15 mg/ml) and propylene glycol 30 % v/v (310.8 mg/ml) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear and colourless aqueous solution free from visible particles pH: 6.5 to 9.0 Osmolarity: 11,077 mOsm/L 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paricalcitol 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 _ _ 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 Page 2 of 9 80 and administered as an intravenous (IV) bolus dose no 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-uremic upper limit of normal, 15.9 to 31.8 pmol/l (150-30 Read the complete document