Land: Storbritannia
Språk: engelsk
Kilde: myHealthbox
Icodextrin
Baxter Healthcare Limited
B05DA
Icodextrin
7.5% w/v
Solution for peritoneal dialysis
intraperitoneal administration
1, 3, 4, 5, 6 unit box
POM - Prescription Only Medicine
Baxter Healthcare S.A
Peritoneal dialytics, Isotonic solutions
It is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.
Authorised
2015-05-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXTRANEAL CLEAR-FLEX SOLUTION FOR PERITONEAL DIALYSIS 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. WHAT IS IN THIS LEAFLET: 1. What EXTRANEAL CLEAR-FLEX is and what it is used for 2. What you need to know before you use EXTRANEAL CLEAR-FLEX 3. How to use EXTRANEAL CLEAR-FLEX 4. Possible side effects 5. How to store EXTRANEAL CLEAR-FLEX 6. Contents of the pack and other information 1. WHAT EXTRANEAL CLEAR-FLEX IS AND WHAT IT IS USED FOR EXTRANEAL CLEAR-FLEX is a solution for peritoneal dialysis. The peritoneal cavity is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. The EXTRANEAL CLEAR-FLEX solution is placed into the peritoneal cavity where it removes water and waste products from your blood. It also corrects abnormal levels of different blood components. EXTRANEAL CLEAR-FLEX may be prescribed for you if: - you are an adult with permanent kidney failure which needs peritoneal dialysis. - standard glucose peritoneal dialysis solutions alone cannot remove sufficient water. 2. WHAT YOU NEED TO KNOW ABOUT EXTRANEAL CLEAR-FLEX Your doctor must supervise you the first time you use this product. DO NOT USE EXTRANEAL CLEAR-FLEX • if you are allergic to icodextrin, starch derivatives or any of the other ingredients of EXTRA Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Extraneal Clear-Flex Solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin 75.0 g/l Sodium chloride 5.4 g/l Sodium (S)-lactate solution equivalent to sodium (S)-lactate 4.5 g/l Calcium chloride 0.257 g/l Magnesium chloride 0.051 g/l Theoretical osmolarity 284 (milliosmoles per litre) Theoretical osmolality 301 (milliosmoles per kg) Contents per 1000 ml electrolyte solution: Sodium 133 mmol/l Calcium 1.75 mmol/l Magnesium 0.25 mmol/l Chloride 96 mmol/l Lactate 40 mmol/l pH = 5,0 to 6,0 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for peritoneal dialysis. Extraneal Clear-Flex is a sterile, clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Extraneal Clear-Flex is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Extraneal Clear-Flex is recommended for use during the longest dwell period, i.e. in CAPD usually overnight and in APD for the long daytime dwell. • The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the physician. _Adults: _ By intraperitoneal administration limited to a single Les hele dokumentet