Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM, CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM, POTASSIUM CHLORIDE, GLUCOSE, GLUCOSE MONOHYDRATE, MAGNESIUM, MAGNESIUM CHLORIDE, HEXAHYDRATE
Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany
B05ZB
CALCIUM CHLORIDE DIHYDRATE 0.1017 g/l CHLORIDE 38 mmol/l POTASSIUM 1.5 mmol/l POTASSIUM CHLORIDE 4.26 g/l GLUCOSE 5.961 mmol/l GLUCOSE MONOHYDRATE 140 g/l LACTATE 5.5 mmol/l MAGNESIUM 108 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 1.1 g/l SODIUM 2 mmol/l SODIUM CHLORIDE 0.1491 g/l SODIUM LACTATE 0.2205 g/l CALCIUM 0.5 mmol/l
SOLUTION FOR HAEMOFILTRATION
CALCIUM CHLORIDE DIHYDRATE 0.1017 g/l CHLORIDE 38 mmol/l POTASSIUM 1.5 mmol/l POTASSIUM CHLORIDE 4.26 g/l GLUCOSE 5.961 mmol/l GLUCOSE MONOHYDRATE 140 g/l LACTATE 5.5 mmol/l MAGNESIUM 108 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 1.1 g/l SODIUM 2 mmol/l SODIUM CHLORIDE 0.1491 g/l SODIUM LACTATE 0.2205 g/l CALCIUM 0.5 mmol/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Withdrawn
2008-12-18
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER MULTILAC 2 MMOL/L POTASSIUM, SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION 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 or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What multiLac 2 mmol/l potassium is and what it is used for 2. What you need to know before you use multiLac 2 mmol/l potassium 3. How to use multiLac 2 mmol/l potassium 4. Possible side effects 5. How to store multiLac 2 mmol/l potassium 6. Contents of the pack and other information 1. WHAT MULTILAC 2 MMOL/L POTASSIUM IS AND WHAT IT IS USED FOR multiLac 2 mmol/l potassium is a continuous Renal Replacement Therapy solution for removal of waste products from the body in people with kidney disease. It is used in patients with kidney injury and also for the treatment of poisoning. The type of solution you are given depends on the amount of potassium (a salt) in your blood. Your doctor will check your potassium levels regularly. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MULTILAC 2 MMOL/L POTASSIUM DO NOT USE MULTILAC 2 MMOL/L POTASSIUM IF you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6) you have hypokalaemia (your potassium level is very low) you have metabolic alkalosis (a condition where there is too much bicarbonate in the blood) you have hyperlactataemia (the amount of lactate in your blood is too high) or a pre-existing liver disease with significantly reduced liver function you have a pre-existing significant cardiac disease you are concomitantly treated with metformin (antidiabetic agent) WARNINGS AND PRECAUTIONS Talk to your doctor before using multiLac 2 mmol/l potassium Must not be Leggi il documento completo
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT multiLac potassium-free solution for haemodialysis/haemofiltration multiLac 2 mmol/l potassium solution for haemodialysis/haemofiltration multiLac 3 mmol/l potassium solution for haemodialysis/haemofiltration multiLac 4 mmol/l potassium solution for haemodialysis/haemofiltration 2. QUALITATIVE AND QUANTITATIVE COMPOSITION multiLac potassium-free/2/3/4 mmol/l potassium is provided in a one-compartment bag containing 5000 ml solution for haemodialysis/haemofiltration. 1000 ML SOLUTION CONTAIN: multiLac potassium-free multiLac 2 mmol/l potassium multiLac 3 mmol/l potassium multiLac 4 mmol/l potassium POTASSIUM CHLORIDE 0.1491 G 0.2237 G 0.2982 G Sodium chloride 5.961 g 5.961 g 5.961 g 5.961 g Sodium (S)-lactate solution 50 % 8.520 g 8.520 g 8.520 g 8.520 g (Sodium (S)-lactate) (4.260 g) (4.260 g) (4.260 g) (4.260 g) Calcium chloride dihydrate 0.2205 g 0.2205 g 0.2205 g 0.2205 g Magnesium chloride hexahydrate 0.1017 g 0.1017 g 0.1017 g 0.1017 g Glucose monohydrate 1.100 g 1.100 g 1.100 g 1.100 g (Glucose) (1.000 g) (1.000 g) (1.000 g) (1.000 g) K + 0 MMOL/L 2.0 MMOL/L 3.0 MMOL/L 4.0 MMOL/L Na + 140 mmol/l 140 mmol/l 140 mmol/l 140 mmol/l (S)-lactate - 38 mmol/l 38 mmol/l 38 mmol/l 38 mmol/l Ca 2+ 1.5 mmol/l 1.5 mmol/l 1.5 mmol/l 1.5 mmol/l Mg 2+ 0.50 mmol/l 0.50 mmol/l 0.50 mmol/l 0.50 mmol/l Cl - 106 mmol/l 108 mmol/l 109 mmol/l 110 mmol/l Glucose 5.5 mmol/l 5.5 mmol/l 5.5 mmol/l 5.5 mmol/l For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for haemodialysis/haemofiltration The solution is clear and colourless and free from visible particles. Theoretical osmolarity multiLac potassium-free 292 mOsm/l Page 2 of 10 multiLac 2 mmol/l potassium 296 mOsm/l multiLac 3 mmol/l potassium 298 mOsm/l multiLac 4 mmol/l potassium 300 mOsm/l pH 4.5 – 6.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS multiLac potassium-free/2/3/4 mmol/l potassium is indicated for intravenous use as substitution solution in haemofi Leggi il documento completo