ประเทศ: สหภาพยุโรป
ภาษา: อังกฤษ
แหล่งที่มา: EMA (European Medicines Agency)
etelcalcetide hydrochloride
Amgen Europe B.V.
H05BX04
etelcalcetide
Anti-parathyroid agents, Calcium homeostasis
Hyperparathyroidism, Secondary
Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Revision: 9
Authorised
2016-11-11
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARSABIV 2.5 MG SOLUTION FOR INJECTION PARSABIV 5 MG SOLUTION FOR INJECTION PARSABIV 10 MG SOLUTION FOR INJECTION_ _ ETELCALCETIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Parsabiv is and what it is used for 2. What you need to know before you use Parsabiv 3. How to use Parsabiv 4. Possible side effects 5. How to store Parsabiv 6. Contents of the pack and other information 1. WHAT PARSABIV IS AND WHAT IT IS USED FOR Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as PTH. Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products. In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small glands in the neck). “Secondary” means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Secondary hyperparathyroidism can cause the loss of calcium from the bones, which can lead to bone pain and fractures and problems with blood and heart vessels. By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARSABIV DO NOT USE PARSABIV - if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6). - if you have very low levels of calcium in your blood. Your doctor will monitor your blood calcium levels. WARNINGS AND PRECAUTIONS Before you are given Parsabiv, tell your doctor if you have or have ever had: heart problems, such as heart failure or arrhythmia อ่านเอกสารฉบับเต็ม
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Parsabiv 2.5 mg solution for injection Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution. Each mL contains 5 mg etelcalcetide. Parsabiv 5 mg solution for injection Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution. Each mL contains 5 mg etelcalcetide. Parsabiv 10 mg solution for injection Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution. Each mL contains 5 mg etelcalcetide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week. Corrected serum calcium should be at or above the lower limit of the normal range prior to administration of first dose of Parsabiv, a dose increase, or reinitiation after a dose stop (see also dose adjustments based on serum calcium levels). Parsabiv should not be administered more frequently than 3 times per week. _Dose titration_ Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg. The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target. 3 _Dose adjustments based on PTH levels_ PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and approximately every 1-3 months during maintenance. Dose adjustment may be necessary at any time during อ่านเอกสารฉบับเต็ม