Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sodium chloride; Calcium chloride; Magnesium chloride; Sodium bicarbonate
Nikkiso Belgium bvba
B05ZB
Sodium chloride; Calcium chloride; Magnesium chloride; Sodium bicarbonate
N/A
Solution for haemofiltration
Product subject to prescription which may not be renewed (A)
Hemofiltrates
Marketed
2006-04-28
Accusol 35 PACKAGE LEAFLET: INFORMATION FOR THE USER ACCUSOL 35, SOLUTION FOR HAEMOFILTRATION, HAEMODIALYSIS AND HAEMODIAFILTRATION 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. If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Accusol 35 is and what it is used for 2. What you need to know before you are given Accusol 35 3. How you will be given Accusol 35 4. Possible side effects 5 How to store Accusol 35 6. Contents of the pack and other information 1. WHAT ACCUSOL 35 IS AND WHAT IT IS USED FOR Accusol 35 is a solution for haemofiltration, haemodialysis and haemodiafiltration. Accusol 35 is prescribed to you if you have temporary or permanent kidney failure. It purifies your blood of waste products; it corrects the acidity or alkalinity and the level of salts in your blood. As a replacement fluid in haemodiafiltration and haemofiltration, it can also be used as a source of salts and water for hydration. Accusol 35 solutions are supplied in a non-PVC bag with two chambers. The two chambers are separated by a long- seal (interchamber seal). Prior to use, the two chambers of Accusol 35 solutions must first be mixed by activating the long-seal (interchamber seal), followed by the activation of the short SafetyMoon seal near the access port. Accusol 35 may be given to you, especially if you have a high level of potassium _. _ Accusol 35 solutions must only be used by or under the direction of a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACCUSOL 35 Before starting the therapy, your doctor will ensure that you have a good access to your vein and artery. He will also ensure that you do not present a high risk of bleeding. Accusol 35 solutions are available in different potassium and glucose concentrations. Your Read the complete document
Health Products Regulatory Authority 30 November 2020 CRN00C23M Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accusol 35 Solution for haemofiltration, haemodialysis and haemodiafiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION PER 1000 ML ACCUSOL 35 LARGE CHAMBER ‘A’ Calcium chloride dihydrate 0.343 g Magnesium chloride hexahydrate 0.136 g Sodium chloride 7.52 g SMALL CHAMBER ‘B’ Sodium bicarbonate 13.4 g FINAL SOLUTION AFTER MIXING PER 1000 ML ACCUSOL 35 Calcium chloride dihydrate 0.257 g Magnesium chloride hexahydrate 0.102 g Sodium chloride 6.12 g Sodium bicarbonate 2.94 g Equivalent to the following ionic composition: IONIC COMPOSITION OF FINAL SOLUTION PER 1000 ML ACCUSOL 35 Calcium (Ca ++ ) 1.75 mmol Magnesium (Mg ++ ) 0.5 mmol Sodium (Na + ) 140 mmol Chloride (Cl - ) 109.3 mmol Bicarbonate (HCO 3 - ) 35 mmol Theoretical osmolarity 287 MOSM/L The 5000 ml of final solution results from the mixing of 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’. The pH of the final solution is between 7.0 -7.5. For the full list of excipients, see section 6.1. The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35 mmol/l). 3 PHARMACEUTICAL FORM Solution for haemofiltration, haemodialysis and haemodiafiltration. Accusol 35 is a sterile, non pyrogenic, clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Accusol 35 is indicated for the treatment of acute and chronic renal failure, as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration. Accusol 35 is primarily intended for use in patients with hyperkalaemia. Health Products Regulatory Authority 30 November 2020 CRN00C23M Page 2 of 6 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For haemofiltration, haemodialysis and haemodiafiltration. Accusol 35 as substitution solution The amount of substitution solution to be administered in adults is determined by the ultra Read the complete document