Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Potassium chloride; Sodium chloride
B. Braun Melsungen AG
B05BB; B05BB01
Potassium chloride; Sodium chloride
0.3%w/ + 0.9 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes
Not marketed
2012-08-24
1d1d1d0d1d1d0d1d1d1d0 1d1d1d0d1d1d0d1d1d1d0 1d1d1d0d1d1d0d1d1d1d0 1d1d1d0d1d1d0d1d1d1d0 273/436492/0417 WHAT IS IN THIS LEAFLET: 1. What Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v is and what it is used for 2. What you need to know before you use Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v 3. How to use Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v 4. Possible side effects 5. How to store Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE 0.3% W/V AND SODIUM CHLORIDE 0.9% W/V IS AND WHAT IT IS USED FOR This medicine contains a solution of potassium chloride and sodium chlo- ride. It is administered given to you through a tube placed into a vein (intravenous drip). You will receive it to maintain or restore your potassium, sodium, chloride and fluid levels when the levels are low. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE DO NOT USE POTASSIUM CHLORIDE 0.3% W/V AND SODIUM CHLORIDE 0.9% W/V • if you have high levels of potassium (hyperkalaemia) or chloride (hyper- chloraemia) or too high levels of sodium (severe hypernatraemia) in your blood • if you have serious kidney disease • if you have too much water in your body (hyperhydration) WARNINGS AND PRECAUTIONS Talk to your doctor before you are given Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Before or when giving you this medicine, your doctor will pay special attention to the following: • High levels of sodium in your blood (hypernatraemia) • Swelling of the lower limbs (oedematous states) or water on your lungs (pulmonary oedema): If you have one of these conditions, you will be given large amounts of this medicine only carefully. • Kidney and liver function: You will receive this medicine as a slow intravenous drip after your doc- tor has made sure that your kidneys and liver are working properly. If they don’t do so, your potassium blood levels and your heart will be monitored while you receive this medicin read_full_document
Health Products Regulatory Authority 22 October 2018 CRN008HGK Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion contains: in 1 000 ml Potassium chloride 3.00 g Sodium chloride 9.00 g _Electrolyte concentrations:_ Potassium 40 mmol/l Sodium 154 mmol/l Chloride 194 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion A clear colourless aqueous solution Theoretical osmolarity (approx.) 380 mOsmol/l pH (approx.) 4.5 – 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Correction or maintenance of potassium, sodium, chloride and fluid balance, depending upon the clinical condition of the patient. The solution is particularly indicated in the treatment of hypokalaemia, hypotonic and isotonic dehydration, and hypochloraemic alkalosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage is dependent on age, weight and clinical condition of the patient, especially those with renal or cardiac insufficiency. Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring. Health Products Regulatory Authority 22 October 2018 CRN008HGK Page 2 of 11 Adequate urine flow must be ensured. _Adults:_ The following recommendations are general guidelines on potassium, however prescribing should follow local guidelines. Potassium The amount required for correction of moderate potassium deficiency and in maintenance may be calculated according to the following formula: mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** – serum-K+actual [mmol/l]) *Term represents the extracellular fluid volume ** should be 4.5 mmol/l The maximum recommended dose of potassium is 2 – 3 mmol/kg b.w./24 h. Fluids Generally, not more than 40 ml fluid/kg b.w./day should be supplied. In cases where more potassium is needed, other read_full_document