国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paricalcitol
AbbVie Ltd
H05BX02
Paricalcitol
5microgram/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 8032853450086
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZEMPLAR 5 MICROGRAMS/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 Zemplar is and what it is used for 2. What you need to know before you are given Zemplar 3. How Zemplar is used 4. Possible side effects 5. How to store Zemplar 6. Contents of the pack and other information 1. WHAT ZEMPLAR IS AND WHAT IS IT USED FOR Zemplar contains the active substance paricalcitol, which is a synthetic form of active vitamin D. Active vitamin D is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin D, when the body cannot produce enough and helps to prevent the consequences of low levels of active vitamin D, in patients with chronic kidney disease namely high levels of parathyroid hormone which can cause bone problems. Zemplar is used in adult patients with kidney disease Stages 5. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEMPLAR YOU SHOULD NOT BE GIVEN ZEMPLAR - 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 be able to tell you if these conditions apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before being given Zemplar. - before the treatment begins, it is important to limit the amount of phosph 完全なドキュメントを読む
OBJECT 1 ZEMPLAR 5 MICROGRAM/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 19-Apr-2018 | AbbVie Limited 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. Each 1 ml vial contains 5 micrograms of paricalcitol. Each 2 ml vial contains 10 micrograms of paricalcitol. Excipients with known effect: Ethanol (20% v/v) and propylene glycol (30% v/v) 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 4. Clinical particulars 4.1 Therapeutic indications Paricalcitol is indicated in adults for the prevention and treatment of secondary hyperparathyroidism in patients with chronic kidney disease Stage 5 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: 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 完全なドキュメントを読む