Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Sodium citrate; Sodium chloride
Gambro Lundia AB
B05ZB
Sodium citrate; Sodium chloride
18/140 mmol/L
Solution for haemofiltration
Product subject to prescription which may not be renewed (A)
Hemofiltrates
Not marketed
2014-11-14
07-19-00-0586 Regiocit UK, IE, MT The following information is intended for healthcare professionals only .......................................15 HU Az alábbi információk kizárólag egészségügyi szakembereknek szólnak ...........................17 RO Următoarele informaţii sunt destinate numai profesioniştilor din domeniul sănătăţii .....................19 BG Посочената по-долу информация е предназначена само за медицински специалисти ..................................21 UK, IE, MT Package leaflet: Information for the user .............................3 HU Betegtájékoztató: Információk a felhasználó számára ........6 RO Prospect: Informaţii pentru utilizator ....................................9 BG Листовка: Информация за потребителя ........................12 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 07-19-00-0586 Date: 28-MAR-2019 Proofread No.: 01 Designer: GSB Page: 1 of 24 BLACK Colour Reference: DRAFT (ITERATION 2) THIS PAGE IS INTENTIONALLY LEFT BLANK BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: 07-19-00-0586 Date: 28-MAR-2019 Proofread No.: 01 Designer: GSB Page: 2 of 24 BLACK Colour Reference: DRAFT (ITERATION 2) PACKAGE LEAFLET: INFORMATION FOR THE USER 3 07-19-00-0586 UK IE MT REGIOCIT SOLUTION FOR HAEMOFILTRATION Citrate, Sodium, Chloride 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, 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 this medicine is and what it is used for 2. What you need to know before you use this medicine 3. How to use this medicine 4. Possible side effects 5. How to store this medicine 6. Content Læs hele dokumentet
Health Products Regulatory Authority 31 January 2020 CRN008TSZ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Regiocit Solution for haemofiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition: Sodium chloride 5.03 g/l Sodium citrate 5.29 g/l Sodium, Na + 140 mmol/l Chloride, Cl - 86 mmol/l Citrate, C 6 H 5 O 7 3- 18 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for haemofiltration The solution is sterile, clear and colourless and free from bacterial endotoxins. Theoretical osmolarity: 244 mOsm/l pH ≈ 7.4 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Regiocit is indicated as replacement fluid for continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Citrate is particularly relevant when systemic anticoagulation with heparin is contraindicated, for example in patients with increased bleeding risks. In paediatric patients, Regiocit is indicated in all age groups provided that the equipment used is adapted to the weight of the child. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The rate at which Regiocit is administered depends on the targeted citrate dose and the prescribed blood flow rate (BFR). The prescription of Regiocit must consider the flow rates of the effluent and other therapeutic fluids, the patient's fluid removal requirements, additional fluid inputs and outputs, and the desired acid-base and electrolyte balance. Regiocit should be prescribed and administration (dose, infusion rate, and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT. The pre-filter infusion rate of Regiocit must be prescribed and adapted relative to the blood flow rate to achieve target blood citrate concentration of 3 to 4 mmol/l of blood. Flow rate for anticoagulation of the extracorporeal circuit should be titrated to achieve a post-filter concentration of ionized calcium in the range 0.25 to 0.35 mmol/l. The patient's systemic ionized calcium conc Læs hele dokumentet