Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, GLUCOSE MONOHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, SODIUM LACTATE
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05DB
CALCIUM CHLORIDE DIHYDRATE 0.184 g/l GLUCOSE MONOHYDRATE 25 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l SODIUM CHLORIDE 5.38 g/l SODIUM HYDROGEN CARBONATE 2.1 g/l SODIUM LACTATE 1.68 g/l
SOLUTION FOR PERITONEAL DIALYSIS
CALCIUM CHLORIDE DIHYDRATE 0.184 g/l GLUCOSE MONOHYDRATE 25 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l SODIUM CHLORIDE 5.38 g/l SODIUM HYDROGEN CARBONATE 2.1 g/l SODIUM LACTATE 1.68 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2006-03-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PHYSIONEAL 40 GLUCOSE 1.36% W/V / 13.6 MG/ML, SOLUTION FOR PERITONEAL DIALYSIS PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 MG/ML, SOLUTION FOR PERITONEAL DIALYSIS PHYSIONEAL 40 GLUCOSE 3.86% W/V / 38.6 MG/ML, 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. - 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 PHYSIONEAL 40 is and what it is used for 2. What you need to know before you use PHYSIONEAL 40 3. How to use PHYSIONEAL 40 4. Possible side effects 5. How to store PHYSIONEAL 40 6. Contents of the pack and other information 1. WHAT PHYSIONEAL 40 IS AND WHAT IT IS USED FOR PHYSIONEAL 40 is a solution for peritoneal dialysis. It removes water and waste products from the blood. It also corrects abnormal levels of different blood components. PHYSIONEAL 40 contains varying levels of glucose (1.36%, 2.27% or 3.86%). The higher the strength of glucose in the solution, the greater the amount of water that will be removed from the blood. PHYSIONEAL 40 may be prescribed to you if you have: • either temporary or permanent kidney failure; • severe water retention; • severe disturbances in the acidity or alkalinity (pH) and the level of salts in your blood; • certain types of drug intoxication where no other treatments are available. PHYSIONEAL 40 solution has an acidity (pH) close to that of your blood. Therefore it may be particularly useful if you experience inflow pain or discomfort with other more acidic Peritoneal Dialysis solutions. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHYSIONEAL 40 Your doctor must supervise you the first time you use this product. DO NOT USE PHYSIONEAL 40 • If you are allergic to the active substances or any of the other i Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Physioneal 40 Glucose 2.27% w/v / 22.7 mg/ml Solution for peritoneal dialysis 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Before mixing 1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER ″ A ″ ) Glucose Monohydrate equivalent to Anhydrous Glucose Calcium Chloride Dihydrate Magnesium Chloride Hexahydrate 68.85 g/l 62.6 g/l 0.507 g/l 0.140 g/l 1000 ML OF BUFFER SOLUTION (LARGE CHAMBER ″ B ″ ) Sodium Chloride Sodium Bicarbonate Sodium Lactate 8.43 g/l 3.29 g/l 2.63 g/l After mixing 1000 ML OF THE MIXED SOLUTION CONTAINS: Glucose monohydrate equivalent to Anhydrous Glucose Sodium Chloride Calcium Chloride Dihydrate Magnesium Chloride Hexahydrate Sodium Bicarbonate Sodium Lactate 25.0 g/l 22.7 g/l 5.38 g/l 0.184 g/l 0.051 g/l 2.10 g/l 1.68 g/l 1000 ml of final solution after mixing corresponds to 362.5 ml of solution A and 637.5 ml of solution B. COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L Anhydrous Glucose (C 6 H 12 O 6 ) Sodium (Na+) Calcium (Ca ++ ) Magnesium (Mg ++ ) Chloride (Cl - ) Bicarbonate (HCO 3 - ) Lactate (C 3 H 5 O 3 - ) 126 mmol/l 132 mmol/l 1.25 mmol/l 0.25 mmol/l 95 mmol/l 25 mmol/l 15 mmol/l For the full list of excipients see section 6.1 The number ‘40’ in the name specifies the buffer concentration of the solution (15 mmol/l of lactate + 25 mmol/l of bicarbonate = 40 mmol/l). 3. PHARMACEUTICAL FORM Solution for peritoneal dialysis. Sterile, clear, colourless solution. The pH of the final solution is 7.4. Osmolarity (MOSMOL/L) 395 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Physioneal 40 is indicated whenever peritoneal dialysis is employed, including: - Acute and chronic renal failure; - Severe water retention; - Severe electrolyte imbalance; - Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available. Bicarbonate/lactate _ _ based Physioneal 40 peritoneal dialysis solutions with a physiological pH are particularly indicated in patients in whom solutions Olvassa el a teljes dokumentumot