Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS
Baxter Healthcare Limited
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYD
4 mMol.
Solution for Haemofiltration
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
EMEA ARTWORK DESIGN CENTRE ARTWORK APPROVAL 4TH DRAFT DATE 16 JAN 2014 RA TO APPROVE LAYOUT AND FORMAT PLANT APPROVAL HALLE ONLY COUNTRY N/A NAME N/A SIGNATURE N/A DATE N/A RA PROOFREADING CHECKLIST PRODUCT INFORMATION PROOFREAD AS PER RA SOP CE-RAPV-009 PRODUCT NAME,STRENGTH,COMPOSITION (API & EXCIPIENTS) COMPLIANCE WITH NATIONAL REGULATIONS CONSISTENCY CHECK WITH ALL FIGURES CITED IN THE PRODUCT INFORMATION BARCODES, SYMBOLS AND RE- IMBURSEMENT INFORMATION STORAGE CONDITIONS AND SHELF-LIFE CB-30-01-853 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ACCUSOL 35 POTASSIUM 4 MMOL/L, 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. What is in this leaflet 1. What ACCUSOL 35 Potassium 4 mmol/l is and what it is used for 2. What you need to know before you are given ACCUSOL 35 Potassium 4 mmol/l 3. How you will be given ACCUSOL 35 Potassium 4 mmol/l 4. Possible side effects 5 How to store ACCUSOL 35 Potassium 4 mmol/l 6. Contents of the pack and other information 1. WHAT ACCUSOL 35 POTASSIUM 4 MMOL/L IS AND WHAT IT IS USED FOR ACCUSOL 35 Potassium 4 mmol/l is a solution for haemofiltration, haemodialysis and haemodiafiltration. ACCUSOL 35 Potassium 4 mmol/l 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). Prio Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accusol 35 Potassium 4 mmol/l Solution for haemofiltration, haemodialysis and haemodiafiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Equivalent to the following ionic composition: 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 COMPOSITION PER 1000 ML ACCUSOL 35 LARGE CHAMBER ‘A’ Calcium chloride dihydrate 0.343 g Magnesium chloride hexahydrate 0.136 g Sodium chloride Potassium chloride Glucose monohydrate 7.52 g 0.398g 1.47g 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 Potassium chloride Glucose anhydrous 2.94 g 0.298g 1.0g IONIC COMPOSITION OF FINAL SOLUTION PER 1000 ML ACCUSOL 35 Calcium (Ca ++ ) 1.75 mmol Magnesium (Mg ++ ) 0.5 mmol Sodium (Na + ) 140 mmol Potassium (K +) Chloride (Cl - ) Glucose anhydrous 4mmol 113.3 mmol 5.55mmol Bicarbonate (HCO 3 - ) 35 mmol Theoretical Osmolarity 300 MOSM/L HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/07/2014_ _CRN 2130021_ _page number: 1_ 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 Baca dokumen lengkapnya