Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate
Baxter Holding B.V.
B05ZB
Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate
Solution for haemodialysis/haemofiltration
Hemofiltrates
Marketed
1999-06-11
PACKAGE LEAFLET: INFORMATION FOR THE USER HEMOSOL B0 SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/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 Hemosol B0 is and what it is used for 2. What you need to know before you use Hemosol B0 3. How to use Hemosol B0 4. Possible side effects 5. How to store Hemosol B0 6. Contents of the pack and other information 1. WHAT HEMOSOL B0 IS AND WHAT IT IS USED FOR Hemosol B0 is used in hospitals in intensive care treatments to correct chemical imbalance of the blood which is caused by kidney failure. The treatments are designed to remove accumulated waste products from the blood when the kidneys are not functioning. Hemosol B0 is used in the following types of treatment in adult and children of all ages: • haemofiltration, • haemodiafiltration and • haemodialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HEMOSOL B0 DO NOT USE HEMOSOL B0: If you are allergic to one of the active substances or any of the other ingredients (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Hemosol B0. Hemosol B0 is a product to be used in hospitals and administered by medical professionals only. They will ensure a safe use of the medicine. Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and concentrations of salts in the blood (electrolytes) will be monitored, including all fluid you are given (intravenous infusion) and that you produce (urine production), even those not directly related to the the Lue koko asiakirja
Health Products Regulatory Authority 21 March 2024 CRN00F6WN Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hemosol B0 solution for haemodialysis/haemofiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hemosol B0 consists of a two compartment PVC bag containing the electrolyte solution in the small compartment (compartment A) and the buffer solution in the large compartment (compartment B). BEFORE RECONSTITUTION 1 000 ml of electrolyte solution (small compartment A) contains: active substances: Calcium chloride, 2H 2 O Magnesium chloride, 6H 2 O Lactic acid 5,145 g 2,033 g 5,4 g 1 000 ml of buffer solution (large compartment B) contains: active substances: Sodium hydrogen carbonate Sodium chloride 3,09 g 6,45 g AFTER RECONSTITUTION The small and the large compartments are mixed to give one reconstituted solution whose ionic composition is: IN MMOL/L IN MEQ/L Calcium Ca 2+ 1,75 3,50 Magnesium Mg 2+ 0,5 1,0 Sodium Na + 140 140 Chloride Cl - 109,5 109,5 Lactate 3 3 Hydrogen carbonate HCO 3 - 32 32 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for haemodialysis/haemofiltration. Clear and colourless reconstituted solution. Theoretical Osmolarity: 287 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis for acute renal failure in adult and children of all ages. Health Products Regulatory Authority 21 March 2024 CRN00F6WN Page 2 of 7 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: The rate at which Hemosol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered will also depend on the desired intensity (dose) of the treatment. The solution should be prescribed and administration (dose, infusion rate, and cumulative volume) should be established only b Lue koko asiakirja