Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
ICODEXTRIN, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM (S)-LACTATE SOLUTION
Baxter Healthcare Limited
B05DA
ICODEXTRIN, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM (S)-LACTATE SOLUTION
Per Cent
Soln for Peritoneal Dialysis
Intraperitoneal administration
bag sizes 1500 ml, 2000 ml and 2500 ml; supplied as single bag or twin bag with a PVC or polypropylene transfer Y-line
Product subject to prescription which may not be renewed (A)
Baxter Healthcare S.A
Peritoneal dialytics, Isotonic solutions
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
2015-05-29
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 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 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 BEFORE YOU USE 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 (e.g. corn (maize) starch) or any of the other ing Perskaitykite visą dokumentą
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. Theoretical osmolarity 284 (milliosmoles per litre) Theoretical osmolality 301 (milliosmoles per kg) Contents per 1000 ml electrolyte solution: 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 an 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 APD therapy in such patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Extraneal Clear-Flex is recommended for use 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 exchange in each 24 hour-period, as part of an APD regimen. 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 dihydrate 0.257 g/l Magnesium chloride hexahydrate 0.051 g/l Sodium 133 mmol/l Calcium 1.75 mmol/l Magnesium 0.25 mmol/l Chloride 96 mmol/l Lactate 40 mmol/l HEALTH PRODUCTS REGULATORY AUTHORITY ___________________________________________________________________________________________________________________ Perskaitykite visą dokumentą