국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Glucose anhydrous ; Glucose monohydrate; Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate
Baxter Holding B.V.
B05DB
Glucose anhydrous ; Glucose monohydrate; Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate
3.86 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 전체 문서 읽기
Health Products Regulatory Authority 19 November 2019 CRN009GH0 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianeal PD4 Glucose 3.86 % w/v (38.6 mg/ml), Solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Anhydrous Glucose 3.86 % w/v 38.60 g/L or Glucose Monohydrate 4.25 % w/v 42.50 g/L Sodium Chloride 0.538 % w/v 5.38 g/L Sodium Lactate 0.448 % w/v 4.48 g/L Calcium Chloride Dihydrate 0.0184 % w/v 184.00 mg/L Magnesium Chloride Hexahydrate 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 a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Peritoneal Dialysis. A clear colourless to pale yellow, solution in PVC containers, which may have an integral administration set and drainage bag. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dianeal PD4 is indicated whenever peritoneal dialysis is employed, including: 1. Acute and chronic renal failure. 2. Severe water retention. 3. Electrolyte disorders. 4. Drug intoxication, when a more adequate therapeutic alternative is not available. Dianeal PD4 is particularly useful for the control of serum calcium and phosphate levels in renal failure patients receiving calcium or magnesium-containing phosphate binders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_: The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the attending physician. Adults Health Products Regulatory Authority 19 November 2019 CRN009GH0 Page 2 of 7 Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 litres. Paediatric population (i.e., newborn to 18 years of age) 800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as tolerated, is recommended. Fil 전체 문서 읽기