Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Glucose (as monohydrate); Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium chloride ph.eur.; Potassium chloride; Sodium hydrogen carbonate; Calcium; Magnesium; Sodium; Lactate; Hydrogen carbonate; Chloride; Potassium; Glucose
Gambro Lundia AB
B05ZB
Glucose (as monohydrate); Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium chloride ph.eur.; Potassium chloride; Sodium hydrogen carbonate; Calcium; Magnesium; Sodium; Lactate; Hydrogen carbonate; Chloride; Potassium; Glucose
2 millimole(s)/litre
Solution for haemodialysis/haemofiltration
Product subject to prescription which may not be renewed (A)
Hemofiltrates
Not marketed
2003-12-12
PACKAGE LEAFLET: INFORMATION FOR THE USER PRISMASOL 2 MMOL/L POTASSIUM SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION CALCIUM CHLORIDE DIHYDRATE/ MAGNESIUM CHLORIDE HEXAHYDRATE/ GLUCOSE MONOHYDRATE/ LACTIC ACID SOLUTION 90% W/W / SODIUM CHLORIDE/ POTASSIUM CHLORIDE/ SODIUM HYDROGEN CARBONATE 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, pharmacist or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Prismasol is and what it is used for 2. What you need to know before you use Prismasol 3. How to use Prismasol 4. Possible side effects 5. How to store Prismasol 6. Contents of the pack and other information 1. WHAT PRISMASOL IS AND WHAT IT IS USED FOR Prismasol contains the active substances calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid solution 90% w/w, sodium chloride, potassium chloride and sodium hydrogen carbonate. Prismasol is used in the treatment of renal failure as a solution for continuous haemofiltration or haemodiafiltration (as a replacement for fluid lost from the blood passing through a filter) and continuous haemodialysis or haemodiafiltration (the blood flows on one side of a dialysis membrane while a haemodialysis solution flows on the other side of the membrane). Prismasol solution may also be used in case of drug poisoning with dialysable or filterable substances. Prismasol 2 mmol/l Potassium is indicated particularly in patients who have tendency to hyperkalaemia (a high concentration of potassium in the blood). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PRISMASOL DO NOT USE PRISMASOL 2 MMOL/L POTASSIUM IN CASE OF: • allergy to one of the active substances or any of the other ingredients (listed in section 6), • a low concen Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prismasol 2 mmol/l Potassium is presented in a two-compartment bag containing in the smaller compartment A, the electrolyte solution, and in the larger compartment B, the buffer solution. The final reconstituted solution is obtained after breaking the frangible pin and mixing both solutions. BEFORE RECONSTITUTION 1 000 ml of electrolyte solution (small compartment A) contains: active substances: Calcium chloride dihydrate 5.145 g Magnesium chloride hexahydrate 2.033 g Glucose 22.00 g (as glucose monohydrate) (S)-Lactic acid 5.400 g (as lactic acid solution 90 %w/w) 1 000 ml of buffer solution (large compartment B) contains: active substances: Sodium chloride 6.45 g Potassium chloride 0.157 g Sodium hydrogen carbonate 3.090 g A+B Calcium chloride, 2 H 2 O 0.257 g Magnesium chloride, 6 H 2 O 0.102 g Glucose 1.100 g Lactic acid 0.270 g Sodium chloride 6.128 g Potassium chloride 0.149 g Sodium hydrogen carbonate 2.936 g AFTER RECONSTITUTION 1 000 ml of the reconstituted solution contains: EACH LITRE OF THE FINAL RECONSTITUTED SOLUTION CORRESPONDS TO 50 ML OF ELECTROLYTE SOLUTION A AND 950 ML OF BUFFER SOLUTION B. For the full list of excipients, see section 6.1. Active substances mmol/l mEq/l Calcium Ca 2+ 1.75 3.50 Magnesium Mg 2+ 0.5 1.0 Sodium Na + 140 140 Chloride Cl - 111.5 111.5 Lactate 3 3 Hydrogen carbonate HCO 3 - 32 32 Potassium K + 2 2 Glucose 6.1 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lees het volledige document