Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose anhydrous ; Glucose monohydrate
Baxter Holding B.V.
B05DB
Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose anhydrous ; Glucose monohydrate
2.27 percent weight/volume
Solution for peritoneal dialysis
Hypertonic solutions
Marketed
1993-06-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIANEAL PD4 GLUCOSE 1.36% W/V / 13.6 MG/ML DIANEAL PD4 GLUCOSE 2.27% W/V / 22.7 MG/ML DIANEAL PD4 GLUCOSE 3.86% W/V / 38.6 MG/ML SOLUTIONS 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 DIANEAL PD4 is and what it is used for 2. What you need to know before you use DIANEAL PD4 3. How to use DIANEAL PD4 4. Possible side effects 5. How to store DIANEAL PD4 6. Contents of the pack and other information 1. WHAT DIANEAL PD4 IS AND WHAT IT IS USED FOR DIANEAL PD4 is a solution for peritoneal dialysis. It removes water and waste products from the blood. It also corrects abnormal levels of different blood components. DIANEAL PD4 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. DIANEAL PD4 may be prescribed to you if you have: either temporary or permanent kidney failure severe water retention severe disturbances in the acidity or alkalinity and the level of salts in your blood certain types of drug intoxication where no other treatments are available. DIANEAL PD4 is particularly indicated for the control of your serum calcium and phosphate levels if you receive calcium or magnesium containing phosphate binders. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIANEAL PD4 DO NOT USE DIANEAL PD4 If you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6). If you have severe lactic acidosis (too much acid in the blood) before you use this solution for the first time. If you have a surgically uncorrectable problem affe Perskaitykite visą dokumentą
HealthProductsRegulatoryAuthority 25February2019 CRN008KFL Page1of6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DianealPD4Glucose2.27%w/v(22.7mg/ml),Solutionforperitonealdialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AnhydrousGlucose 2.27% w/v 22.70 g/L or GlucoseMonohydrate 2.50% w/v 25.00 g/L SodiumChloride 0.538% w/v 5.38 g/L SodiumLactate 0.448% w/v 4.48 g/L CalciumChlorideDihydrate 0.0184% w/v 184.00 mg/L MagnesiumChlorideHexahydrate 0.0051% w/v 51.00 mg/L MMOL/L Na + 132.00 Ca 2+ 1.25 Mg 2+ 0.25 Cl - 95.00 C 3 H 5 O 3 - 40.00 For afulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM SolutionforPeritonealDialysis. Aclearcolourlesstopaleyellow,solutioninPVCcontainers,whichmayhaveanintegraladministrationsetanddrainagebag. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DianealPD4isindicatedwheneverperitonealdialysisisemployed,including: 1. Acuteandchronicrenalfailure. 2. Severewaterretention. 3. Electrolytedisorders. 4. Drugintoxication,whenamoreadequatetherapeuticalternativeisnotavailable. DianealPD4isparticularlyusefulforthecontrolofserumcalciumandphosphatelevelsinrenalfailurepatientsreceiving calciumormagnesium-containingphosphatebinders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_: Themodeoftherapy,frequencyoftreatment,exchangevolume,durationofdwellandlengthofdialysisshouldbeselectedby theattendingphysician. Adults HealthProductsRegulatoryAuthority 25February2019 CRN008KFL Page2of6 Patientsoncontinuousambulatoryperitonealdialysis(CAPD)typ Perskaitykite visą dokumentą