Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
CALCIUM CHLORIDE, ICODEXTRIN, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05DA
CALCIUM CHLORIDE 0.257 g/l ICODEXTRIN 75 g/l MAGNESIUM CHLORIDE 0.051 g/l SODIUM CHLORIDE 5.4 g/l SODIUM LACTATE 4.5 g/l
SOLUTION FOR PERITONEAL DIALYSIS
CALCIUM CHLORIDE 0.257 g/l ICODEXTRIN 75 g/l MAGNESIUM CHLORIDE 0.051 g/l SODIUM CHLORIDE 5.4 g/l SODIUM LACTATE 4.5 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2005-12-29
PACKAGE LEAFLET: INFORMATION FOR THE USER EXTRANEAL SOLUTION FOR PERITONEAL DIALYSIS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • 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 EXTRANEAL is and what it is used for 2. What you need to know before you use EXTRANEAL 3. How to use EXTRANEAL 4. Possible side effects 5. How to store EXTRANEAL 6. Contents of the pack and other information 1. WHAT EXTRANEAL IS AND WHAT IT IS USED FOR EXTRANEAL 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 solution is placed into the peritoneal cavity where it removes water and waste products from the blood. It also corrects abnormal levels of different blood components. EXTRANEAL 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 Your doctor must supervise you the first time you use this product. DO NOT USE EXTRANEAL • if you are allergic to icodextrin or starch derivatives (e.g. maize starch) or any of the other ingredients of EXTRANEAL • if you are intolerant to maltose or isomaltose (sugar coming from starch) • if you have glycogen storage disease • if you already have severe lactic acidosis (too much acid in the blood) • if you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections • if you have documented loss of peritoneal function due to severe peritoneal scarring WARNING Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT EXTRANEAL (Icodextrin 7.5%) 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 g/L Sodium Chloride 5.4 g/L 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) Electrolyte solution content per 1000 ml: Sodium 133 mmol/L Calcium 1.75 mmol/L Magnesium 0.25 mmol/L Chloride 96 mmol/L Lactate 40 mmol/L pH = 5 to 6 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for peritoneal dialysis. Extraneal is a sterile, clear, colorless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Extraneal 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 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 exchange in each 24 hour-period, as part of a CAPD or APD regimen. The volume to be instilled should be given over a period of approximately 10 to 20 minutes at a rate which the patient finds comfortable. For adult patients of normal body size the instilled volume should not exceed 2.0 L. For larger patients (more than 70-75 kg), a fill volume of 2.5 L may be used. If the instilled Lesen Sie das vollständige Dokument