Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium (s)-lactate solution; Sodium bicarbonate
Baxter Holding B.V.
B05DB
Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium (s)-lactate solution; Sodium bicarbonate
22.7 micromole(s)
Solution for peritoneal dialysis
Hypertonic solutions
Marketed
2004-09-10
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PHYSIONEAL 35 GLUCOSE 1.36% W/V / 13.6 MG/ML CLEAR-FLEX, SOLUTION FOR PERITONEAL DIALYSIS PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7 MG/ML CLEAR-FLEX, SOLUTION FOR PERITONEAL DIALYSIS PHYSIONEAL 35 GLUCOSE 3.86% W/V / 38.6 MG/ML 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. - 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 35 is and what it is used for 2. What you need to know before you use PHYSIONEAL 35 3. How to use PHYSIONEAL 35 4. Possible side effects 5. How to store PHYSIONEAL 35 6. Contents of the pack and other information 1. WHAT PHYSIONEAL 35 IS AND WHAT IT IS USED FOR PHYSIONEAL 35 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 35 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 35 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 35 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 35 Your doctor must supervise you the first time you use this product. DO NOT USE PHYSIONEAL 35 - If you are allergic to the Прочетете целия документ
HealthProductsRegulatoryAuthority 29March2019 CRN008KFV Page1of9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Physioneal35Glucose2.27%w/v/22.7mg/mlClear-Flex, Solutionforperitonealdialysis. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Beforemixing 1000 ML OF ELECTROLYTE SOLUTION (LARGE CHAMBER ²A²) CONTAINS: Activesubstances: Glucosemonohydrate equivalenttoGlucoseanhydrous Calciumchloridedihydrate Magnesiumchloridehexahydrate 33.3g 30.3g 0.343g 0.068g 1000 ML OF BUFFER SOLUTION (SMALL CHAMBER ²B²) CONTAINS: Activesubstances: Sodiumchloride Sodiumhydrogencarbonate Sodium(S)-lactatesolutionequivalenttosodium(S)-lactate 21.12g 9.29g 4.48g Aftermixing 1000 ML OF THE MIXED SOLUTION CONTAINS: Activesubstances: Glucosemonohydrate equivalenttoGlucoseanhydrous Sodiumchloride Calciumchloridedihydrate Magnesiumchloridehexahydrate Sodiumhydrogencarbonate Sodium(S)-lactatesolutionequivalenttosodium(S)-lactate 25.0g 22.7g 5.67g 0.257g 0.051g 2.10g 1.12g 1000mloffinalsolutionaftermixingcorrespondsto750mlofsolutionAand250mlofsolutionB. COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L Glucoseanhydrous(C 6 H 12 O 6 ) Na + Ca ++ Mg ++ Cl - HCO 3 - C 3 H 5 O 3 - 126mmol/l 132mmol/l 1.75mmol/l 0.25mmol/l 101mmol/l 25mmol/l 10mmol/l Forthefulllistofexcipients,seesection6.1. Thenumber‘35’inthenamespecifiesthebufferconcentrationofthesolution(10mmol/loflactate+25mmol/lofhydrogen carbonate=35mmol/l). HealthProductsRegulatoryAuthority 29March2019 CRN008KFV Page2of9 3 PHARMACEUTICAL FORM Solutionforperitonealdial Прочетете целия документ