Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, LACTIC ACID, CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, GLUCOSE ANHYDROUS
Gambro Lundia AB
B05ZB
MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, LACTIC ACID, CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, GLUCOSE ANHYDROUS
SOLUTION FOR HAEMOFILTRATION
MAGNESIUM CHLORIDE HEXAHYDRATE 0.102 millimole(s)/litre ; SODIUM CHLORIDE 6.128 millimole(s)/litre ; SODIUM HYDROGEN CARBONATE 2.936 millimole(s)/litre ; LACTIC ACID 0.27 millimole(s)/litre ; CALCIUM CHLORIDE DIHYDRATE 0.257 millimole(s)/litre ; POTASSIUM CHLORIDE 0.149 millimole(s)/litre ; GLUCOSE ANHYDROUS 1.1 millimole(s)/litre
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2010-03-23
1 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 conc Olvassa el a teljes dokumentumot
Page 1 of 11 S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration 2 Q UALITATIVE 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 or peel seal 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: 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 Page 2 of 11 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. 3 P HARMACEUTICAL FORM Solution for haemodialysis/haemofiltration Clear reconstituted solution with a slightly yellow colour. Theoretical Osmolarity: 297 mOsm/l pH of the reconstituted solution: 7.0–8.5 4 C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prismasol 2 mmol/l Potassium is used in the treatment of renal failure, as substitution solution in haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodia Olvassa el a teljes dokumentumot