Страна: Малта
Език: английски
Източник: Medicines Authority
DISODIUM PHOSPHATE, DIHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE
Gambro Lundia AB
B05ZB
DISODIUM PHOSPHATE, DIHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE
SOLUTION FOR HAEMODIALYSIS, SOLUTION FOR HAEMOFILTRATION
DISODIUM PHOSPHATE DIHYDRATE 0.187 gram(s)/litre ; MAGNESIUM CHLORIDE HEXAHYDRATE 3.05 gram(s)/litre ; SODIUM CHLORIDE 7.01 gram(s)/litre ; SODIUM HYDROGEN CARBONATE 2.12 gram(s)/litre ; POTASSIUM CHLORIDE 0.314 gram(s)/litre
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2015-02-19
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, DISODIUM PHOSPHATE DIHYDRATE 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 Biphozyl is and what it is used for 2. What you need to know before you use Biphozyl 3. How to use Biphozyl 4. Possible side effects 5. How to store Biphozyl 6. Contents of the pack and other information 1. WHAT BIPHOZYL IS AND WHAT IT IS USED FOR This medicine is a solution for dialysis treatment (haemofiltration, haemodialysis and haemodiafiltration) which is used to remove waste products from the blood when the kidneys are not functioning. This medicine is used in hospitals during intensive care treatment using Continuous Renal Replacement Therapy (CRRT). This medicine is particularly used to treat critically ill patients with acute kidney injury having: • a normal concentration of potassium (normal kalaemia) in the blood • a normal pH in the blood • a normal or low concentration of phosphate (normal or hypophosphataemia) in the blood • a high concentration of calcium (hypercalcaemia) in the blood This medicine may also be used • when other bicarbonate sources are available or when extracorporeal circuit is anticoagulated with citrate. • in case of drug poisoning or intoxications with dialysable or filterable substances. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BIPHOZYL _ _ DO NOT USE BIPHOZYL IN CASE OF: • allergy to one of the active substances or any of the other ingredients (listed in section 6) • a low concentration of calcium (hypo Прочетете целия документ
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 9 1. NAME OF THE MEDICINAL PRODUCT Biphozyl Solution for haemodialysis / haemofiltration 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Biphozyl is presented in a two-compartment bag. The final reconstituted solution is obtained after opening the peel seal and mixing the contents of the two compartments. BEFORE RECONSTITUTION Composition in the small compartment: Magnesium chloride hexahydrate 3.05 g/l Composition in the large compartment: Sodium chloride 7.01 g/l Sodium hydrogen carbonate 2.12 g/l Potassium chloride 0.314 g/l Disodium phosphate dihydrate 0.187 g/l AFTER RECONSTITUTION Composition of the reconstituted solution: - Active substances mmol/l mEq/l - Sodium Na + 140 140 - Potassium K + 4 4 - Magnesium Mg 2+ 0.75 1.5 - Chloride Cl - 122 122 - Hydrogen phosphate HPO 4 2- 1 2 - Hydrogen carbonate HCO 3 - 22 22 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for haemodialysis / haemofiltration Clear and colourless solution Theoretical osmolarity: 290 mOsm/l pH = 7.0 – 8.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Biphozyl is used as replacement solution and as dialysate for treatment of acute kidney injury during continuous renal replacement therapy (CRRT). Biphozyl is used in a post-acute phase after initiation of renal replacement therapy when pH, potassium and phosphate concentration have returned to normal. Biphozyl is also used when other buffer sources are available as well as during regional citrate anticoagulation. Moreover, Biphozyl is used in patients with hypercalcaemia. Page 3 of 9 Biphozyl may also be used in cases of drug poisoning or intoxications when the substances are dialysable or filterable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The volume and rate at which Biphozyl is administered depends on the blood concentration of phosphate and other electrolytes, acid–base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or Прочетете целия документ