Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Dipotassium phosphate ; Potassium dihydrogen phosphate
B. Braun Medical Limited
B05XA; B05XA06
Dipotassium phosphate ; Potassium dihydrogen phosphate
1mmol/ml + 0.6 millimole(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Electrolyte solutions; potassium phosphate, incl. combinations with other potassium salts
Marketed
1993-02-24
PACKAGE LEAFLET: INFORMATION FOR THE USER B. Braun Medical Limited, Dublin 12 POTASSIUM PHOSPHATE 1 MMOL/ML + 0.6 MMOL/ML CONCENTRATE FOR SOLUTION FOR INFUSION Dipotassium Phosphate, Potassium Dihydrogen Phosphate 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 pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. What Potassium Phosphate is and what it is used for 2. What you need to know before you use Potassium Phosphate 3. How to use Potassium Phosphate 4. Possible side effects 5. How to store Potassium Phosphate 6. Contents of the pack and other information 1. WHAT POTASSIUM PHOSPHATE IS AND WHAT IT IS USED FOR Potassium Phosphate is a concentrated solution of potassium phosphate intended for the intravenous supply of phosphate (intravenous = administration by a vein drip).. Potassium Phosphate is used if you are lacking both potassium and phosphate at the same time. Potassium Phosphate is administered to you by a doctor or other health professional. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTASSIUM PHOSPHATE POTASSIUM PHOSPHATE SHOULD NOT BE GIVEN TO YOU IF YOU HAVE • excessively high blood levels of phosphate or potassium • abnormally low blood calcium level • kidney impairment • a disease or condition associated with an abnormally high blood potassium level, such as - lack of fluid - high levels of acidic substances in your blood due to decompensated diabetes (diabetic ketoacidosis) - kidney impairment with low urine excretion -a specific disease of the adrenal gland (ADDISON’S disease), - a certain inherited disease of potassium metabolism associated Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 10 September 2019 CRN0099LT Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Phosphate 1mmol/ml + 0.6mmol/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule (=20 ml) of concentrate for solution for infusion contains Dipotassium phosphate 1.394 g Potassium dihydrogen phosphate 0.544 g _Electrolyte concentrations_ Potassium 1 mmol/ml Phosphate 0.6 mmol/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear, colourless aqueous solution Theoretical osmolarity 1600 mOsm/l pH 6.8 – 7.2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phosphate substitution in intensive-care patients, with co-existing potassium deficiency, in whom close monitoring of serum potassium and phosphate concentrations can be performed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The dose is adjusted according to the actual basic or correction requirements, according to the analytical values of the serum electrolyte concentrations. _Adults_ In the setting of parenteral nutrition the basic phosphate requirement in adults is 0.3 – 0.5 mmol per kg body weight (BW) per day, corresponding to 0.5 – 0.8 ml per kg BW per day. In therapy of severe hypophosphataemia the dose is adjusted according to the serum phosphate concentration. Then higher amounts than those stated above may be needed. Per 0.6 mmol phosphate 1 mmol of potassium is administered. The maximum daily dose of potassium is 2 – 3 mmol per kg BW Health Products Regulatory Authority 10 September 2019 CRN0099LT Page 2 of 8 _Paediatric patients_ The dose should be adjusted strictly according to the prevailing serum potassium and phosphate concentrations which may be affected by fluid retention, dehydration or excessive water losses. In children potassium intake during parenteral nutrition is recommended not to exceed 1 – 3 mmol/kg body weight per day. Parenteral phosphat Lesen Sie das vollständige Dokument